Medical device - Knowledge (XXG)

1582:, and technical glitches with this technology. While only a few studies have looked at the susceptibility of medical devices to hacking, there is a risk. In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly via radio hardware, an antenna, and a personal computer. These researchers showed they could shut down a combination heart defibrillator and pacemaker and reprogram it to deliver potentially lethal shocks or run out its battery. Jay Radcliff, a security researcher interested in the security of medical devices, raised fears about the safety of these devices. He shared his concerns at the Black Hat security conference. Radcliff fears that the devices are vulnerable and has found that a lethal attack is possible against those with insulin pumps and glucose monitors. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the safety of their devices. As recently as June 2011, security experts showed that by using readily available hardware and a user manual, a scientist could both tap into the information on the system of a wireless insulin pump in combination with a glucose monitor. With the PIN of the device, the scientist could wirelessly control the dosage of the insulin. Anand Raghunathan, a researcher in this study, explains that medical devices are getting smaller and lighter so that they can be easily worn. The downside is that additional security features would put an extra strain on the battery and size and drive up prices. Dr. William Maisel offered some thoughts on the motivation to engage in this activity. Motivation to do this hacking might include acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer's reputation; sabotage; intent to inflict financial or personal injury or just satisfaction for the attacker. Researchers suggest a few safeguards. One would be to use rolling codes. Another solution is to use a technology called "body-coupled communication" that uses the human skin as a wave guide for wireless communication. On 28 December 2016, the US 197: 1333:, published in JAMA Internal Medicine, examined the scientific evidence that is publicly available about medical implants that were cleared by the FDA 510(k) process from 2008 to 2012. They found that scientific evidence supporting "substantial equivalence" to other devices already on the market was required by law to be publicly available, but the information was available for only 16% of the randomly selected implants, and only 10% provided clinical data. Of the more than 1,100 predicate implants that the new implants were substantially equivalent to, only 3% had any publicly available scientific evidence, and only 1% had clinical evidence of safety or effectiveness. The researchers concluded that publicly available scientific evidence on implants was needed to protect the public health. 1040: 437:, is "any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in: the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in a human being; the restoration, correction or modification of a body function or the body structure of a human being; the diagnosis of pregnancy in a human being; or the care of a human being during pregnancy and at and after the birth of a child, including the care of the child. It also includes a 47:. The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own regulatory framework); but more updates are triggered as also the relation related to the recognition of conformity assessment certificates between the European Union and Switzerland changed since 26 May 2021. 1959:

1980s when the potential health hazards of medical waste on the East Coast beaches became highlighted by the media. Connecting the large demand for medical equipment and single-use medical devices, with a need for waste reduction, as well as the problem of unequal access for low-income communities led to the Congress enacting the Medical Waste Tracking Act of 1988. Medical equipment can be donated either by governments or non-governmental organizations, domestic or international. Donated equipment ranges from bedside assistance to radiological equipment.

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over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions.

75: 1322:, showed that most medical devices recalled in the last five years for "serious health problems or death" had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases, the devices had been deemed so low-risk that they did not they did not undergo any FDA regulatory review. Of the 113 devices recalled, 35 were for cardiovascular issues. This study was the topic of Congressional hearings re-evaluating FDA procedures and oversight. 1443:

other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants 3. ASTM F3172: Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices

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review of current practice and guidelines for the donation of medical equipment for surgical and anaesthesia care in LMICs has demonstrated a high level of complexity within the donation process and numerous shortcomings. Greater collaboration and planning between donors and recipients is required together with evaluation of donation programs and concerted advocacy to educate donors and recipients on existing equipment donation guidelines and policies.

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country market share. The largest market shares in Europe (in order of market share size) belong to Germany, Italy, France, and the United Kingdom. The rest of the world comprises regions like (in no particular order) Australia, Canada, China, India, and Iran. This article discusses what constitutes a medical device in these different regions and throughout the article these regions will be discussed in order of their global market share.

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necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients".

1642: 463: 348:(CA) is a body with authority to act on behalf of the member state to ensure that member state government transposes requirements of medical device directives into national law and applies them. The CA reports to the minister of health in the member state. The CA in one Member State has no jurisdiction in any other member state, but exchanges information and tries to reach common positions. 1739: 4990: 67: 589: 133:(FD&C Act) in 1938 that medical devices were regulated. Later in 1976, the Medical Device Amendments to the FD&C Act established medical device regulation and oversight as we know it today in the United States. Medical device regulation in Europe as we know it today came into effect in 1993 by what is collectively known as the 1508:

Recipients of this typically developed an infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient.

874:. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not require sterilization or do not measure a function) can be marketed purely by self-certification. 1962:

Medical equipment donation has come under scrutiny with regard to donated-device failure and loss of warranty in the case of previous-ownership. Most medical devices and production company warranties to do not extend to reused or donated devices, or to devices donated by initial owners/patients. Such

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This refers chiefly to similarly low-risk measuring devices. Included in this category are: thermometers, droppers, and non-invasive blood pressure measuring devices. Once again the manufacturer must provide a technical file and be certified by a European Notified Body for manufacturing in accordance

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Class I devices are subject to the least regulatory control and are not intended to help support or sustain life or be substantially important in preventing impairment to human health, and may not present an unreasonable risk of illness or injury. Examples of Class I devices include elastic bandages,

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The regulatory authorities recognize different classes of medical devices based on their potential for harm if misused, design complexity, and their use characteristics. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in

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According to Article 1 of Council Directive 93/42/EEC, 'medical device' means any "instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic

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which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term 'device' does not include software functions excluded pursuant to

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and protect users from their unintended use, soon followed by European and other regulatory agencies. This guidance distinguishes the apps subjected to regulation based on the marketing claims of the apps. Incorporation of the guidelines during the development phase of such apps can be considered as

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For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body.

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Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue. Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and

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published in the peer-reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life-threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are

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The European classification depends on rules that involve the medical device's duration of body contact, invasive character, use of an energy source, effect on the central circulation or nervous system, diagnostic impact, or incorporation of a medicinal product. Certified medical devices should have

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Slightly more complex than IIa devices, class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. Identical compliance route to Class IIa devices with

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Medical device manufacturing requires a level of process control according to the classification of the device. Higher risk; more controls. When in the initial R&D phase, manufacturers are now beginning to design for manufacturability. This means products can be more precision-engineered to for

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A study by Dr. Stephanie Fox-Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients

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Similar to hazards, cybersecurity threats and vulnerabilities cannot be eliminated but must be managed and reduced to a reasonable level. When designing medical devices, the tier of cybersecurity risk should be determined early in the process in order to establish a cybersecurity vulnerability and

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decided that the "Sympto" app, used to analyze a woman's menstrual cycle, was a medical device because it calculates a fertility window for each woman using personal data. The manufacturer, Sympto-Therm Foundation, argued that this was a didactic, not a medical process. the court laid down that an

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A global definition for medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. Although these bodies often collaborate and discuss the definition in general, there are subtle differences in wording that prevent a

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The global medical device market was estimated to be between $ 220 and US$ 250 billion in 2013. The United States controls ≈40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%). Although collectively Europe has a larger share, Japan has the second largest

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Failure to meet cost targets will lead to substantial losses for an organisation. In addition, with global competition, the R&D of new devices is not just a necessity, it is an imperative for medical device manufacturers. The realisation of a new design can be very costly, especially with the

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Class III devices are strictly high risk devices. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. The steps to approval here include a full quality assurance system audit, along with examination of both the device's design and the device itself by a European Notified

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Class IIa devices generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term. Class IIa devices are those which are installed within the body for only between 60 minutes and 30 days. Examples include hearing-aids, blood transfusion tubes, and

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They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive

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The circulation of medical equipment is not limited to donations. The rise of reuse and recycle-based solutions, where gently-used medical equipment is donated and redistributed to communities in need, is another form of equipment distribution. An interest in reusing and recycling emerged in the

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sets precedence because it signifies that a company engages in the creation of new products. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. Further standards are

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The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and

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are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of

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estimates that 95% of medical equipment in low- and middle-income countries (LMICs) is imported and 80% of it is funded by international donors or foreign governments. While up to 70% of medical equipment in sub-Saharan Africa is donated, only 10%–30% of donated equipment becomes operational. A

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perspective, with low-resource countries unable to obtain or afford essential and life-saving equipment. In these settings, well-intentioned equipment donation from high- to low-resource settings is a frequently used strategy to address this through individuals, organisations, manufacturers and

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The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. Most AI/ML devices focus upon radiology. As of 2020, there was no

1421:. It is important to document and ensure that packages meet regulations and end-use requirements. Manufacturing processes must be controlled and validated to ensure consistent performance. EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling. 1336:

In 2014–2015, a new international agreement, the Medical Device Single Audit Program (MDSAP), was put in place with five participant countries: Australia, Brazil, Canada, Japan, and the United States. The aim of this program was to "develop a process that allows a single audit, or inspection to

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produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the

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Classifying medical devices based on their risk is essential for maintaining patient and staff safety while simultaneously facilitating the marketing of medical products. By establishing different risk classifications, lower risk devices, for example, a stethoscope or tongue depressor, are not

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recognizes four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer's declaration of device safety and

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Class Is devices are similarly non-invasive devices, however this sub-group extends to include sterile devices. Examples of Class Is devices include stethoscopes, examination gloves, colostomy bags, or oxygen masks. These devices also require a technical file, with the added requirement of an

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The ASTM F04.15.17 task group is working on several new standards that involve designing implants for cleaning, selection and testing of brushes for cleaning reusable devices, and cleaning assessment of medical devices made by additive manufacturing. Additionally, the FDA is establishing new

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India has introduced National Medical Device Policy 2023. However, certain medical devices are notified as DRUGS under the Drugs & Cosmetics Act. Section 3 (b) (iv) relating to definition of "drugs" holds that "Devices intended for internal or external use in the diagnosis, treatment,

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production to result in shorter lead times, tighter tolerances and more advanced specifications and prototypes. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.

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The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.

311:, defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators, to facilitate free movement of goods inside the EU. 558:

required to undergo the same level of testing that higher risk devices such as artificial pacemakers undergo. Establishing a hierarchy of risk classification allows regulatory bodies to provide flexibility when reviewing medical devices.

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Classes I and II distinguish between extremely low and low risk devices. Classes III and IV, moderate and high risk respectively, are highly and specially controlled medical devices. In vitro diagnostics have three risk classifications.

1929:) is a vital component of the healthcare delivery system. Employed primarily by hospitals, BMETs are the people responsible for maintaining a facility's medical equipment. BMET mainly act as an interface between doctor and equipment. 401:(PAL) defines medical devices as "instruments and apparatus intended for use in diagnosis, cure or prevention of diseases in humans or other animals; intended to affect the structure or functions of the body of man or other animals." 538: 448:

reviews medical devices to assess their safety, effectiveness, and quality before authorizing their sale in Canada. According to the Act, medical device does not include any device that is intended for use in relation to animals.

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Non-invasive, everyday devices or equipment. Class I devices are generally low risk and can include bandages, compression hosiery, or walking aids. Such devices require only for the manufacturer to complete a Technical File.

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of the definition of a medical device, thus the appropriate definition of a medical device depends on the region. Often a portion of the definition of a medical device is intended to differentiate between medical devices and

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reuse raises matters of patient autonomy, medical ethics, and legality. Such concerns conflict with the importance of equal access to healthcare resources, and the goal of serving the greatest good for the greatest number.

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For the remaining regions in the world, the risk classifications are generally similar to the United States, European Union, and Japan or are a variant combining two or more of the three countries' risk classifications.

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Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury and require

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The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, Ir, IIa, IIb or III, it must be verified by a

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is a medical device if it is to be used for any of the medical purposes provided by law, and creates or modifies health information by calculations or comparison, providing information about an individual patient.

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On September 25, 2013, the FDA released a draft guidance document for regulation of mobile medical applications, to clarify what kind of mobile apps related to health would not be regulated, and which would be.

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is highly regulated. Often medical devices and products are sterilized in the package. Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special

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effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny. A guidance document for device classification is published by Health Canada.

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The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the

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defines a device as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

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Fox-Rawlings S,. Gottschalk L.B., Doamekpor L., Zuckerman D.M. (2018) Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly, 96 (3); 499-529.

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specific regulatory pathway for AI/ML-based medical devices in the US or Europe. However, in January 2021, the FDA published a proposed regulatory framework for AI/ML-based software, and the

2562:"Title 21—Food and drugs: Chapter i—Food and drug administration: Department of health and human services: Subchapter H—Medical devices: Part 860 Medical device classification procedures" 976:. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control. Various rules identify the device's category 1106:

Cosmetics runs under 1945. CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices.

3100: 1253:. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for 735:. Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, stereotaxic navigation systems, and surgical robots. 1353: 1293:

Starting in the late 1980s, the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (

1297:) that overdosed patients because of software coding errors. FDA is now focused on regulatory oversight on medical device software development process and system-level testing. 129:

and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the

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Wu E, Wu K, Daneshjou R, Ouyang D, Ho DE, Zou J (April 2021). "How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals".

1039: 4730:"Medical equipment donation in low-resource settings: a review of the literature and guidelines for surgery and anaesthesia in low-income and middle-income countries" 444:

The term covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.

196: 2064: 743:. Examples of Class III devices include implantable pacemakers, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. 3681: 370:

In September 2012, the European Commission proposed new legislation aimed at enhancing safety, traceability, and transparency. The regulation was adopted in 2017.

3581:"Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)" 2896: 2871: 1906:

Air purifying equipment may be used in the periphery of the operating room or at point sources including near the surgical site for the removal of surgical plume.

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Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)"

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testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

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mitigation or prevention of disease or disorder in human beings or animals" are also drugs. As of April 2022, 14 classes of devices are classified as drugs.

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Zuckerman D, Brown P, Das A (November 2014). "Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices".

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In August 2013, the FDA released over 20 regulations aiming to improve the security of data in medical devices, in response to the growing risks of limited

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Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,

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Carroll GT, Kirschman DL (2023-01-23). "Catalytic Surgical Smoke Filtration Unit Reduces Formaldehyde Levels in a Simulated Operating Room Environment =".

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shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time.

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Yetisen AK, Martinez-Hurtado JL, da Cruz Vasconcellos F, Simsekler MC, Akram MS, Lowe CR (March 2014). "The regulation of mobile medical applications".

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developing a medical device; the regulations have to adapt and propositions for expedite approval may be required due to the nature of 'versions' of

3654: 2587: 1102:). Medical devices under the Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. 2621: 1470:

guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes. New research was published in

4512:"Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)" 751:

The classification of medical devices in the European Union is outlined in Article IX of the Council Directive 93/42/EEC and Annex VIII of the

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which replaces the EU Medical Device Directive in May 2021, defines regulatory requirements for medical devices, including AI/ML software.

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Eze S, Ijomah W, Wong TC (July 2020). "Remanufacturing: a potential sustainable solution for increasing medical equipment availability".

2536: 4606:"A Peripherally Located Air Recirculation Device Containing an Activated Carbon Filter Reduces VOC Levels in a Simulated Operating Room" 4347:"Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis" 3240:"Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health" 1950:), supply chains, user education and the appropriateness of donations means these frequently fail to deliver the intended benefits. The 1330: 1305: 886:

standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, do not reuse, etc.

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allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including

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purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

1943: 1922: 1659: 484: 363:. The conformity of a medium or high risk medical device with relevant regulations is also assessed by an external entity, the 206: 144:

Medical devices vary in both their intended use and indications for use. Examples range from simple, low-risk devices such as

4543:"The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics" 1706: 1663: 488: 2762: 1082:

Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and

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recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness.

355:(MHRA) acted as a CA. In Italy it is the Ministero Salute (Ministry of Health) Medical devices must not be mistaken with 4519: 4488: 4217: 3746: 2179: 1911: 1789: 1619: 1599: 1587: 1583: 1555: 1494: 752: 643: 604: 572: 378: 165: 138: 4085: 3503:"Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis" 3026: 2295: 3580: 3460: 2794:"Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)" 2715: 1685: 1418: 1218: 721: 248: 545:(U.S. FDA product code BZS), a popular Class I medical device as determined by the U.S. FDA, ubiquitous in hospitals. 473: 2705:

MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

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application to a European Notified Body for certification of manufacturing in conjunction with sterility standards.

755:. There are basically four classes, ranging from low risk to high risk, Classes I, IIa, IIb, and III (this excludes 4994: 1894: 1578:. Some of these devices can be remotely controlled. This has engendered concern about privacy and security issues, 732: 414: 160:

to complex, high-risk devices that are implanted and sustain life. One example of high-risk devices are those with

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Subchapter H—Medical Devices. Subpart B includes quality system requirements, an important component of which are

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The Danger Within Us: America's Untested, Unregulated Medical Device Industry and One Man's Battle to Survive It

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catheters. Requirements include technical files and a conformity test carried out by a European Notified Body.

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Halperin D, Heydt-Benjamin TS, Ransford B, Clark SS, Defend B, Morgan W, Fu K, Kohno T, Maisel WJ (May 2008).

2348: 307:, rules that relate to safety and performance of medical devices were harmonised in the EU in the 1990s. The 4293:"The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database" 3296:

Lenzer J (November 2018). "FDA recommends "modernizing" review of devices in wake of global investigation".

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Packaging materials and systems for medical devices to be sterilized, General requirements and test methods

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Canadian classes of medical devices correspond to the European Council Directive 93/42/EEC (MDD) devices:

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Medical devices (excluding in vitro diagnostics) in Japan are classified into four classes based on risk:

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Diagnostic medical equipment may also be used in the home for certain purposes, e.g. for the control of

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Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

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diagnostics including software, which fall in four classes: from A (lowest risk) to D (highest risk)):

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The future core legal framework consists of two regulations, replacing the previous three directives:

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Zuckerman DM, Brown P, Nissen SE (June 2011). "Medical device recalls and the FDA approval process".

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on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and

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and which does not achieve its principal intended action in or on the human body by pharmacological,

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ASTM F2475-11 – Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

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Class II devices are subject to special labeling requirements, mandatory performance standards and

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Globe and Mail. Thursday Oct. 27, 2011 Jim Finkle. Insulin Pumps Vulnerable to Attacks by Hackers

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Pacemakers and implantable cardiac defibrillators: Software radio attacks and zero-power defenses

3797: 3364: 3321: 2109: 1826: 1571: 1287: 740: 434: 244: 173: 3339:

Coombes R (November 2018). "Surgeons call for compulsory registers of all new medical devices".

618: 598: 102:

Discovery of what would be considered a medical device by modern standards dates as far back as

4129: 3219: 2482:"A review of medical device regulations in India, comparison with European Union and way-ahead" 1446:

In addition, the cleanliness of re-usable devices has led to a series of standards, including:

1368: 4968: 4918: 4859: 4761: 4670: 4635: 4564: 4465: 4406: 4368: 4324: 4066: 4027: 3848: 3789: 3721: 3439: 3356: 3313: 3269: 3195: 3160: 2742: 2686: 2513: 2378: 2328: 2206: 2104: 2039: 1918:(GMDN) which have been endorsed by the International Medical Device Regulatory Forum (IMDRF). 1883: 1773: 1758: 1087: 639: 356: 3659:

U.S. Department of Health and Human Services - Food and Drug Administration - Medical Devices

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practices. This approach further mitigates risks and increases visibility of quality issues.

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With the rise of smartphone usage in the medical space, in 2013, the FDA issued to regulate

1517: 1483: 1313: 214:, as the regulatory requirements of the two are different. Definitions also often recognize 145: 4109:. Proceedings of the 29th Annual IEEE Symposium on Security and Privacy. pp. 129–142. 1390:

Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

281:

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

4885:

Runge MW, Baman TS, Davis S, Weatherwax K, Goldman E, Eagle KA, Crawford TC (April 2017).

4045:

Pycroft L, Boccard SG, Owen SL, Stein JF, Fitzgerald JJ, Green AL, Aziz TZ (August 2016).

2850: 2119: 1777: 1595: 1410: 1341: 1326: 1301: 1283: 1242: 1241:

standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality and

1047: 423: 219: 161: 2921: 1337:

ensure the medical device regulatory requirements for all five countries are satisfied".

260:

Intended to affect the structure or any function of the body of man or other animals, and

3936: 3413: 2143: 1910:

The identification of medical devices has been recently improved by the introduction of

284:

investigation, replacement or modification of the anatomy or of a physiological process,

49:

Please help update this article to reflect recent events or newly available information.

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In 2018, an investigation involving journalists across 36 countries coordinated by the

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Medical devices in India are regulated by Central Drugs Standard Control Organisation (

419: 211: 4363: 4346: 1384:

measure the ability of the package to maintain sterility. Relevant standards include:

1356:(ICIJ) prompted calls for reform in the United States, particularly around the 510(k) 5004: 4871: 4682: 4418: 4241:"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" 2419: 2114: 1938: 1804: 1797: 1606: 1309: 1258: 1058: 871: 445: 438: 364: 153: 3996:"Security and privacy issues in implantable medical devices: A comprehensive survey" 3801: 3611:"Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors" 3368: 3325: 3191: 3528:"Standard Practice for Reporting and Assessment of Residues on Single Use Implants" 2124: 1818: 1222: 1083: 1043: 169: 3156: 3101:"A Formal Methods-based verification approach to medical device software analysis" 2157: 1570:, including deep-brain stimulators, can incorporate the ability to transmit vital 1458:

Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors

1183:

Iranian Health Ministry in terms of safety and performance based on EU-standards.

332:(IVDR) will replace the EU's current Directive on In-Vitro Diagnostic (98/79/EC)). 94:

is any device intended to be used for medical purposes. Significant potential for

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also published a series of guidances for industry regarding this topic against

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There are challenges surrounding the availability of medical equipment from a

1738: 1586:

released its recommendations that are not legally enforceable for how medical

1360:

process; the investigation prompted similar calls in the UK and Europe Union.

1279: 295:

or metabolic means, but which may be assisted in its function by such means;"

292: 177: 4863: 4674: 4666: 4621: 2498: 2180:"A History of Medical Device Regulation & Oversight in the United States" 1598:). The medical device design approach employed should be consistent with the 1197:

standards to applicant countries, including 40 Asian and European countries.

4715:"Barriers to innovation in the field of medical devices: background paper 6" 4146:

Hacking Medical Devices for Fun and Insulin: Breaking the Human SCADA System

3255: 3215:"Australia, Brazil, Canada, Japan, and the US: Safeguarding Medical Devices" 1754: 1631: 1430: 1377: 1294: 1271: 1266:

which is for electrical devices (mains-powered as well as battery powered),

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is generally needed when a health facility acquires a new device to perform

617:

to the section by replacing the section with a link and a summary or by

180:. The design of medical devices constitutes a major segment of the field of 122: 114: 4922: 4765: 4639: 4568: 4469: 4410: 4372: 4328: 4070: 4031: 3852: 3793: 3555: 3360: 3317: 3273: 3199: 3164: 2517: 1193:

Some producers in Iran export medical devices and supplies which adhere to

4989: 4903: 4185:"New cybersecurity guidelines for medical devices tackle evolving threats" 3610: 3588: 3527: 3502: 3483: 2763:"Australian regulatory guidelines for medical devices (ARGMD) Version 1.1" 4805: 4780: 3833: 2649:. American College of Acupuncture & Oriental Medicine. Archived from 1890: 757: 4854: 3632: 2249:"Council Directive 93/42/EEC of 14 June 1993 concerning medical devices" 1372:

Curette in sterile pouch. Porous tyvek material allows gas sterilization

4114: 4022: 3785: 2203:

Plastics in Medical Devices: Properties, Requirements, and Applications

1051: 879: 711:

General Controls + Special controls (510K) + Pre-Market Approval (PMA)

427: 360: 278:

diagnosis, prevention, monitoring, treatment or alleviation of disease,

66: 3352: 3309: 855:

an added requirement of a device type examination by a Notified Body.

537: 4936: 3434:

Bix L, Fuente J (2009). "Medical Device Packaging". In Yam KL (ed.).

157: 95: 2296:"Directive 2007/47/ec of the European parliament and of the council" 4484:"FDA Releases Artificial Intelligence/Machine Learning Action Plan" 4047:"Brainjacking: Implant Security Issues in Invasive Neuromodulation" 3984:

New Health Hazard:Hackable Medical Implants. MSNBC.com's Technology

2324:

Clinical Evaluation of Medical Devices: Principles and Case Studies

2160:. University of Virginia Claude Moore Health Services Library. 2007 1200:

Some Iranian producers export their products to foreign countries.

1162:

Pacemakers, Defibrillators, Implanted prosthetics, Breast implants

817:

Pacemakers, Defibrillators, Implanted prosthetics, Breast implants

714:

Pacemakers, Defibrillators, Implanted prosthetics, Breast implants

3224: 2021: 1875: 1871: 1812: 1808: 1367: 1099: 1038: 536: 413: 195: 118: 81: 73: 65: 3717: 2739:

Medical Device Regulatory Practices: An International Perspective

318:

Directive 90/385/EEC regarding active implantable medical devices

314:

The previous core legal framework consisted of three directives:

2069: 1947: 1926: 1879: 1842: 1179: 3817:"Can standards and regulations keep up with health technology?" 686:

Tongue Depressor, Electric Toothbrush, Bandages, Hospital Beds

70:

Tongue depressor, a Class I medical device in the United States

1951: 1856: 1785: 1635: 1001:

Class I - measuring or Class I - supplied sterile or class IIa

747:

European Union (EU) and European Free Trade Association (EFTA)

582: 456: 218:

as a subclass of medical devices and establish accessories as

29: 3633:"Committee F04 on Medical and Surgical Materials and Devices" 3053:"Preparing a Complaints/eMDR System for Upcoming FDA Mandate" 1942:

charities. However, issues with maintenance, availability of

359:. In the EU, all medical devices must be identified with the 86:

Artificial pacemaker, a Class III device in the United States

78:

Infusion pump, a Class II medical device in the United States

3874:

Guidance for Industry and Food and Drug Administration Staff

3485:

Extractable residue from recalled Inter-Op acetabular shells

1974:

Medical & Biological Engineering & Computing journal

1590:

should maintain the security of Internet-connected devices.

4210:"Postmarket Management of Cybersecurity in Medical Devices" 3682:"Researchers find ways to keep medical tools pathogen free" 1245:

regarding the topic for regulatory purposes is convened by

1186:

Some Iranian medical devices are produced according to the

1075:

Class III (Canada) generally corresponds to Class IIb (ECD)

579:

Federal Food, Drug, and Cosmetic Act § Medical devices

3491:. 49th Annual Meeting of the Orthopaedic Research Society. 1129:

Tongue depressors, Wheelchairs, Spectacles, Alcohol Swabs

1078:

Class IV (Canada) generally corresponds to Class III (ECD)

1072:

Class II (Canada) generally corresponds to Class IIa (ECD)

3710:

Methods in Research and Development of Biomedical Devices

2022:

Biomedical Engineering and Technology (incubation) Centre

1257:

in local markets, and most export markets. Additionally,

3815:

Vincent CJ, Niezen G, O'Kane AA, Stawarz K (June 2015).

1870:

Medical laboratory equipment automates or helps analyze

728:

examination gloves, and hand-held surgical instruments.

4696: 3876:. U.S. Food and Drug Administration. 27 September 2022. 3002:"ISO Standards Applied to Medical Device Manufacturing" 1069:

Class I (Canada) generally corresponds to Class I (ECD)

4345:

Muehlematter UJ, Daniore P, Vokinger KN (March 2021).

4130:"A Heart Device is Found Vulnerable to Hacker Attacks" 3461:"Sample Size Selection Using Margin of Error Approach" 1594:

management approach (including a set of cybersecurity

200:

Medical devices were used for surgery in ancient Rome.

4240: 2876:"11.100.20: Biological evaluation of medical devices" 2414: 2412: 2375:

Handbook of Medical Device Regulatory Affairs in Asia

1354:

International Consortium of Investigative Journalists

1270:

which is for Active implantable medical devices, and

4340: 4338: 724:, Title 21, part 860 (usually known as 21 CFR 860). 4887:"Pacemaker recycling: A notion whose time has come" 4728:Marks IH, Thomas H, Bakhet M, Fitzgerald E (2019). 4173:

Daily Tech June 15, 2011 Nidhi SubbaramanDaily Tech

1666:. Unsourced material may be challenged and removed. 1405:

Packaging for terminally sterilized medical devices

720:The classification procedures are described in the 353:

Medicines and Healthcare products Regulatory Agency

340:The government of each Member State must appoint a 4272:. U.S. Government Publishing Office. 6 August 2013 3994:Camara C, Peris-Lopez P, Tapiador JE (June 2015). 2683:Surgical Robotics: Systems Applications and Vision 778:Class I (Class I, Class Is, Class Im, Class Ir) 697:General Controls + Pre-Market Notification (510K) 3482:Spiegelberg SH, Deluzio KJ, Muratoglu OK (2003). 3384:"Optimizing Package Design for EtO Sterilization" 2772:. Australian Government. May 2011. Archived from 2531: 2529: 2527: 2229:. U.S. Food & Drug Administration. 2018-11-03 2182:. U.S. Food & Drug Administration. 2018-11-03 2002:- Strathclyde Institute of Medical Devices (SIMD) 1902:continuous passive range of motion (CPM) machines 1780:machines, used to aid in diagnosis. Examples are 2425:. Department of Justice Canada. 16 December 2011 1217:ensure that they fulfil their intended purpose. 550:combination with drugs, and regulation of these 4697:"International Medical Device Regulators Forum" 4432:Gerke S, Babic B, Evgeniou T, Cohen IG (2020). 3889:"FDA Eases the Way for New Product Development" 3123:"Infusion Pump Software Safety Research at FDA" 2815:"Medical Device Regulation In Canada: A Primer" 2788: 2786: 2065:Federal Institute for Drugs and Medical Devices 700:Catheters, Contact Lenses, Pregnancy Test Kits 237:Federal Food Drug & Cosmetic (FD&C) Act 3961:"Cybersecurity risks in professional services" 2897:International Organization for Standardization 2872:International Organization for Standardization 2647:"Frequently Asked Questions about Acupuncture" 1988:University-based research packaging institutes 1215:Validation and verification of medical devices 386:In Vitro Diagnostic medical devices regulation 3238:Ronquillo JG, Zuckerman DM (September 2017). 3055:. Sparta Systems. 18 May 2015. Archived from 2090:Instruments used in obstetrics and gynecology 1210:Validation and verification (medical devices) 321:Directive 93/42/EEC regarding medical devices 8: 4827: 4825: 3909:Jordan Robertson. Associated Press 8/4/2011 3708:Wong K, Tu J, Sun Z, Dissanayake DW (2013). 1900:Therapeutic: physical therapy machines like 1489:Design, prototyping, and product development 328:diagnostic medical devices (Until 2022, the 231:United States (Food and Drug Administration) 4086:"Excuse Me While I turn off Your Pacemaker" 3550: 3548: 3099:Jones P, Jetley R, Abraham J (2010-02-09). 2616: 2614: 2612: 2610: 2608: 2349:"Revision of the medical device directives" 1825:a patient's bodily function. This includes 891:Federal Administrative Court of Switzerland 491:. Unsourced material may be challenged and 433:The term medical device, as defined in the 4604:Carroll GT, Kirschman DL (December 2022). 4541:Beckers R, Kwade Z, Zanca F (March 2021). 4384: 4382: 3655:"Reprocessing of Reusable Medical Devices" 3585:ASTM International - Products and Services 3436:Wiley Encyclopedia of Packaging Technology 3406:"ASTM International - Standards Worldwide" 2566:CFR – Code of Federal Regulations Title 21 2445:"Medical Devices Regulations (SOR/98-282)" 2146:. 6 April 2006 – via news.bbc.co.uk. 2008:- Medical Device Research Institute (MDRI) 1602:for managing cybersecurity-related risks. 1433:- Biological Evaluation of Medical Devices 1340:In 2017, a study by Dr. Jay Ronquillo and 4912: 4902: 4853: 4755: 4745: 4629: 4558: 4459: 4449: 4362: 4318: 4308: 4164:Daily Tech June 15, 2011 Nidhi Subbaraman 4021: 4011: 3944: 3842: 3832: 3263: 2507: 2497: 2327:. Springer Science & Business Media. 1726:Learn how and when to remove this message 1025:Active implantable medical devices (AIMD) 784:Tongue Depressor, Wheelchair, Spectacles 511:Learn how and when to remove this message 367:, before it can be placed on the market. 4291:Benjamens S, Dhunnoo P, Meskó B (2020). 3507:ASTM International Products and Services 2420:"Medical Devices Regulations SOR/98-282" 2158:"Surgical Instruments from Ancient Rome" 1981:Expert Review of Medical Devices journal 1914:(UDI) and standardised naming using the 1737: 1108: 978: 909: 763: 659: 3703: 3701: 2949:"Quality Systems ISO 13485 - Canada.ca" 2368: 2366: 2135: 1329:, Paul Brown, and Dr. Aditi Das of the 1233:Standardization and regulatory concerns 980:Medical device categories in Australia 948:High Risk could cause life-threatening 3465:Medical Device and Diagnostic Industry 3388:Medical Device and Diagnostic Industry 2588:"General Controls for Medical Devices" 554:takes this factor into consideration. 27:Device to be used for medical purposes 4243:. U.S. Food & Drug Administration 2770:The Therapeutics Goods Administration 2467:"National Medical Device Policy 2023" 1474:to keep Medical Tools pathogen free. 344:responsible for medical devices. The 168:, and which assist in the conduct of 7: 2843:"Iran's Medical Devices at a glance" 2671:. U.S. Food and Drug Administration. 2085:Instruments used in general medicine 1664:adding citations to reliable sources 489:adding citations to reliable sources 131:Federal Food, Drug, and Cosmetic Act 2628:. U.S. Food and Drug Administration 2594:. U.S. Food and Drug Administration 2568:. U.S. Food and Drug Administration 2543:. U.S. Food and Drug Administration 1472:ACS Applied Interfaces and Material 1331:National Center for Health Research 1306:National Center for Health Research 3027:"Standards (Medical Devices)]" 2321:Becker KM, Whyte JJ (2007-11-05). 2227:"Is The Product A Medical Device?" 2144:"Stone age man used dentist drill" 1916:Global Medical Device Nomenclature 1630:For other types of equipment, see 25: 4000:Journal of Biomedical Informatics 3031:U.S. Food and Drug Administration 2486:Perspectives in Clinical Research 2095:List of common EMC test standards 1893:mellitus, such as in the case of 4988: 4655:ACS Chemical Health & Safety 2447:. Food and Drugs Act. 2019-03-04 1944:biomedical equipment technicians 1640: 974:Therapeutic Goods Administration 587: 461: 34: 3712:. World Scientific Publishing. 3192:10.1001/jamainternmed.2014.4193 2373:Wong J, Kaiyu RT (2013-03-27). 1923:biomedical equipment technician 1769:There are several basic types: 1651:needs additional citations for 397:Article 2, Paragraph 4, of the 3213:Trautman K (16 January 2015). 2622:"General and Special Controls" 1996:- Medical Devices Center (MDC) 1057:The Medical Devices Bureau of 441:but does not include a drug." 1: 4967:. Little, Brown and Company. 4364:10.1016/S2589-7500(20)30292-2 4183:Becker R (27 December 2016). 3867:"Mobile Medical Applications" 3742:"Mobile Medical Applications" 3157:10.1001/archinternmed.2011.30 3145:Archives of Internal Medicine 2399:"Canada's Food and Drugs Act" 2055:Electromagnetic compatibility 1895:continuous glucose monitoring 1803:Treatment equipment includes 1757:, monitoring or treatment of 1319:Archives of Internal Medicine 418:Bags of medical supplies and 330:In Vitro Diagnosis Regulation 324:Directive 98/79/EC regarding 103: 4520:Food and Drug Administration 4489:Food and Drug Administration 4218:Food and Drug Administration 3919:Altawy R, Youssef A (2016). 3747:Food and Drug Administration 3225:Food and Drug Administration 2947:Canada Health (2003-01-02). 2664:Melkerson MN (May 2, 2018). 1912:Unique Device Identification 1753:) is designed to aid in the 1620:EU medical device regulation 1600:NIST Cybersecurity Framework 1584:Food and Drug Administration 1495:Medical device manufacturing 1151:Ventilators, Infusion pumps 841:with metrology regulations. 806:Ventilators, Infusion pumps 753:EU medical device regulation 644:Food and Drug Administration 640:Food, Drug, and Cosmetic Act 605:Medical device manufacturing 573:Medical device manufacturing 351:In the UK, for example, the 137:(MDD). On May 26, 2017, the 4891:World Journal of Cardiology 4804:US EPA, OLEM (2016-02-17). 4779:US EPA, OLEM (2016-02-17). 4585:. www.thefreedictionary.com 4267:Vol 78, No 151, page 47712" 3946:10.1109/ACCESS.2016.2521727 3887:Piccardo C (28 July 2014). 2901:"11.040: Medical equipment" 2796:. Health Canada. 2015-04-23 2718:. Lexology. 6 November 2018 2351:. European Commission. 2013 2014:- School of Packaging (SoP) 1529:mobile medical applications 1523:Mobile medical applications 1419:verification and validation 1204:Validation and verification 1140:Hearing aids, Thermometers 722:Code of Federal Regulations 601:the scope of other articles 251:, or any supplement to them 249:United States Pharmacopoeia 243:recognized in the official 117:dentists used flint-tipped 5032: 4846:10.1007/s13243-020-00080-0 4834:Journal of Remanufacturing 4560:10.1016/j.ejmp.2021.02.011 4403:10.1038/s41591-021-01312-x 4351:The Lancet. Digital Health 4310:10.1038/s41746-020-00324-0 4128:Feder BJ (12 March 2008). 4084:Takahashi D (8 Aug 2008). 4063:10.1016/j.wneu.2016.05.010 3965:SkyNet Managed IT Services 3532:ASTM Products and Services 2205:(2nd ed.). Elsevier. 1933:Medical equipment donation 1629: 1547: 1515: 1492: 1481: 1425:Biocompatibility standards 1274:for medical software. The 1219:Validation or verification 1207: 1172: 1086:machines (Class III), and 1050:logistics headquarters in 576: 570: 426:Logistics Headquarters in 399:Pharmaceutical Affairs Law 379:Medical Devices Regulation 4747:10.1136/bmjgh-2019-001785 4451:10.1038/s41746-020-0262-2 4013:10.1016/j.jbi.2015.04.007 3103:. Embedded Systems Design 2050:Durable medical equipment 2012:Michigan State University 2000:University of Strathclyde 1574:from a patient's body to 1415:quality management system 940:High Risk on Malfunction 868:Certificate of Conformity 139:Medical Device Regulation 43:This article needs to be 4667:10.1021/acs.chas.2c00071 4622:10.1021/acsomega.2c05570 3821:JMIR mHealth and uHealth 2822:Health Technology Update 2666:"Stereotaxic Instrument" 2499:10.4103/picr.picr_222_20 2480:Manu M, Anand G (2022). 2060:Electronic health record 1554:Medical devices such as 562:Classification by region 528:Regulation and oversight 141:(MDR) replaced the MDD. 135:Medical Device Directive 3686:Business Standard India 3459:Fotis N, Bix L (2006). 3256:10.1111/1468-0009.12278 2737:Theisz V (2015-08-03). 2537:"Device Classification" 1994:University of Minnesota 1613:Artificial intelligence 1358:substantial equivalence 1175:Cancer Diagnostic Probe 1046:wait to be used at the 733:postmarket surveillance 669:FDA Regulatory Control 3180:JAMA Internal Medicine 2100:Medical grade silicone 2080:Home medical equipment 1743: 1373: 1304:and Paul Brown of the 1148:Moderate to High Risk 1054: 889:In November 2018, the 546: 430: 287:control of conception, 235:Section 201(h) of the 201: 182:biomedical engineering 87: 79: 71: 4937:"School of Packaging" 4904:10.4330/wjc.v9.i4.296 3244:The Milbank Quarterly 1821:equipment is used to 1741: 1576:medical professionals 1550:Medical device hijack 1548:Further information: 1438:Cleanliness standards 1371: 1255:regulatory compliance 1137:Low to Moderate Risk 1042: 619:splitting the content 613:and help introduce a 577:Further information: 540: 417: 226:Definitions by region 199: 85: 77: 69: 4997:at Wikimedia Commons 4583:"ar·ma·men·tar·i·um" 4438:npj Digital Medicine 4297:npj Digital Medicine 3834:10.2196/mhealth.3918 3081:. Computingcases.org 3079:"Therac-25 Timeline" 3059:on 20 September 2015 2035:Assistive technology 1835:anaesthetic machines 1660:improve this article 1588:device manufacturers 1568:surgical instruments 1325:A 2014 study by Dr. 1300:A 2011 study by Dr. 803:Medium to High Risk 552:combination products 485:improve this section 439:contraceptive device 388:(IVDR (EU) 2017/746) 216:In vitro diagnostics 207:global harmonization 150:medical thermometers 4941:School of Packaging 4616:(50): 46640–46645. 3937:2016IEEEA...4..959A 3891:. NPI Services, Inc 2045:Design history file 2006:Flinders University 1839:heart-lung machines 1827:medical ventilators 1776:equipment includes 1364:Packaging standards 1342:Dr. Diana Zuckerman 1316:, published in the 981: 621:into a new article. 533:Risk classification 381:(MDR (EU) 2017/745) 346:competent authority 342:competent authority 4221:. 28 December 2016 4134:The New York Times 4115:10.1109/SP.2008.31 4051:World Neurosurgery 3786:10.1039/C3LC51235E 3680:ANI (2019-12-08). 3121:FDA (2010-09-08). 2974:"ISO 13485 in USA" 2302:. 5 September 2007 2110:Medical technology 1967:Academic resources 1815:surgical machines. 1759:medical conditions 1744: 1572:health information 1534:mobile application 1374: 1288:quality management 1088:cardiac pacemakers 1055: 979: 859:Class III Devices: 852:Class IIb Devices: 845:Class IIa Devices: 741:premarket approval 611:discuss this issue 547: 435:Food and Drugs Act 431: 357:medicinal products 299:EU Legal framework 245:National Formulary 202: 88: 80: 72: 4993:Media related to 4963:Lenzer J (2017). 4734:BMJ Global Health 4492:. 12 January 2021 3727:978-981-4434-99-7 3445:978-0-470-08704-6 3353:10.1136/bmj.k5010 3310:10.1136/bmj.k5026 3186:(11): 1781–1787. 3151:(11): 1006–1011. 2692:978-1-4419-1125-4 2334:978-1-59745-004-1 2253:eur-lex.europa.eu 2201:Sastri V (2013). 2105:Medical logistics 2040:Clinical engineer 1847:dialysis machines 1747:Medical equipment 1742:Medical equipment 1736: 1735: 1728: 1710: 1626:Medical equipment 1558:, insulin pumps, 1310:Dr. Steven Nissen 1166: 1165: 1032: 1031: 959:Rest of the world 952: 951: 838:Class Im Devices: 831:Class Is Devices: 821: 820: 718: 717: 683:General Controls 636: 635: 521: 520: 513: 405:Rest of the world 265:section 520(o)." 162:embedded software 154:disposable gloves 146:tongue depressors 64: 63: 18:Healthcare device 16:(Redirected from 5023: 4992: 4978: 4951: 4950: 4948: 4947: 4933: 4927: 4926: 4916: 4906: 4882: 4876: 4875: 4857: 4829: 4820: 4819: 4817: 4816: 4801: 4795: 4794: 4792: 4791: 4776: 4770: 4769: 4759: 4749: 4725: 4719: 4718: 4711: 4705: 4704: 4693: 4687: 4686: 4650: 4644: 4643: 4633: 4601: 4595: 4594: 4592: 4590: 4579: 4573: 4572: 4562: 4538: 4532: 4531: 4529: 4527: 4516: 4508: 4502: 4501: 4499: 4497: 4480: 4474: 4473: 4463: 4453: 4429: 4423: 4422: 4386: 4377: 4376: 4366: 4357:(3): e195–e203. 4342: 4333: 4332: 4322: 4312: 4288: 4282: 4281: 4279: 4277: 4271: 4265:Federal Register 4259: 4253: 4252: 4250: 4248: 4237: 4231: 4230: 4228: 4226: 4214: 4206: 4200: 4199: 4197: 4195: 4180: 4174: 4171: 4165: 4162: 4156: 4153: 4147: 4144: 4138: 4137: 4125: 4119: 4118: 4100: 4094: 4093: 4081: 4075: 4074: 4042: 4036: 4035: 4025: 4015: 3991: 3985: 3982: 3976: 3975: 3973: 3972: 3957: 3951: 3950: 3948: 3916: 3910: 3907: 3901: 3900: 3898: 3896: 3884: 3878: 3877: 3871: 3863: 3857: 3856: 3846: 3836: 3812: 3806: 3805: 3769: 3763: 3762: 3760: 3759: 3750:. 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MK Precision 2993: 2965: 2939: 2913: 2888: 2863: 2834: 2806: 2782: 2754: 2747: 2729: 2707: 2698: 2691: 2674: 2656: 2653:on 2014-03-18. 2638: 2604: 2579: 2553: 2523: 2472: 2458: 2436: 2408: 2390: 2383: 2362: 2340: 2333: 2313: 2300:Eur-lex Europa 2287: 2265: 2240: 2218: 2211: 2193: 2171: 2149: 2134: 2132: 2129: 2128: 2127: 2122: 2117: 2112: 2107: 2102: 2097: 2092: 2087: 2082: 2077: 2075:Health Level 7 2072: 2067: 2062: 2057: 2052: 2047: 2042: 2037: 2030: 2027: 2026: 2025: 2015: 2009: 2003: 1997: 1989: 1986: 1985: 1984: 1977: 1968: 1965: 1934: 1931: 1908: 1907: 1904: 1898: 1887: 1868: 1865:blood pressure 1850: 1816: 1805:infusion pumps 1801: 1798:x-ray machines 1796:scanners, and 1766: 1763: 1734: 1733: 1648: 1646: 1639: 1627: 1624: 1614: 1611: 1564:defibrillators 1560:operating room 1545: 1542: 1524: 1521: 1516:Main article: 1513: 1510: 1493:Main article: 1490: 1487: 1482:Main article: 1479: 1476: 1467: 1466: 1460: 1454: 1439: 1436: 1435: 1434: 1426: 1423: 1408: 1407: 1401: 1395: 1392: 1365: 1362: 1234: 1231: 1208:Main article: 1205: 1202: 1195:European Union 1188:European Union 1170: 1167: 1164: 1163: 1160: 1157: 1153: 1152: 1149: 1146: 1142: 1141: 1138: 1135: 1131: 1130: 1127: 1124: 1120: 1119: 1116: 1113: 1095: 1092: 1080: 1079: 1076: 1073: 1070: 1036: 1033: 1030: 1029: 1026: 1022: 1021: 1018: 1014: 1013: 1012:Medium - high 1010: 1006: 1005: 1002: 998: 997: 994: 990: 989: 988:Level of risk 986: 985:Classification 969: 966: 960: 957: 950: 949: 946: 942: 941: 938: 934: 933: 930: 926: 925: 924:Insignificant 922: 918: 917: 914: 904: 901: 819: 818: 815: 812: 808: 807: 804: 801: 797: 796: 793: 790: 786: 785: 782: 779: 775: 774: 771: 768: 748: 745: 716: 715: 712: 709: 706: 702: 701: 698: 695: 692: 688: 687: 684: 681: 678: 674: 673: 670: 667: 664: 658: 657: 654: 651: 634: 633: 595: 593: 586: 571:Main article: 568: 565: 563: 560: 534: 531: 529: 526: 519: 518: 469: 467: 460: 454: 451: 420:defibrillators 411: 408: 406: 403: 394: 391: 390: 389: 382: 334: 333: 322: 319: 300: 297: 289: 288: 285: 282: 279: 270: 269:European Union 267: 262: 261: 258: 252: 232: 229: 227: 224: 193: 190: 107: 7000 BC 92:medical device 62: 61: 42: 40: 33: 26: 24: 14: 13: 10: 9: 6: 4: 3: 2: 5028: 5017: 5014: 5012: 5009: 5008: 5006: 4996: 4991: 4987: 4986: 4982: 4976: 4970: 4966: 4961: 4960: 4956: 4942: 4938: 4932: 4929: 4924: 4920: 4915: 4910: 4905: 4900: 4896: 4892: 4888: 4881: 4878: 4873: 4869: 4865: 4861: 4856: 4851: 4847: 4843: 4839: 4835: 4828: 4826: 4822: 4811: 4807: 4800: 4797: 4786: 4782: 4775: 4772: 4767: 4763: 4758: 4753: 4748: 4743: 4739: 4735: 4731: 4724: 4721: 4716: 4710: 4707: 4702: 4701:www.imdrf.org 4698: 4692: 4689: 4684: 4680: 4676: 4672: 4668: 4664: 4660: 4656: 4649: 4646: 4641: 4637: 4632: 4627: 4623: 4619: 4615: 4611: 4607: 4600: 4597: 4584: 4578: 4575: 4570: 4566: 4561: 4556: 4552: 4548: 4544: 4537: 4534: 4522: 4521: 4513: 4507: 4504: 4491: 4490: 4485: 4479: 4476: 4471: 4467: 4462: 4457: 4452: 4447: 4443: 4439: 4435: 4428: 4425: 4420: 4416: 4412: 4408: 4404: 4400: 4396: 4392: 4385: 4383: 4379: 4374: 4370: 4365: 4360: 4356: 4352: 4348: 4341: 4339: 4335: 4330: 4326: 4321: 4316: 4311: 4306: 4302: 4298: 4294: 4287: 4284: 4268: 4266: 4258: 4255: 4242: 4236: 4233: 4220: 4219: 4211: 4205: 4202: 4190: 4186: 4179: 4176: 4170: 4167: 4161: 4158: 4152: 4149: 4143: 4140: 4135: 4131: 4124: 4121: 4116: 4112: 4108: 4107: 4099: 4096: 4091: 4087: 4080: 4077: 4072: 4068: 4064: 4060: 4056: 4052: 4048: 4041: 4038: 4033: 4029: 4024: 4019: 4014: 4009: 4005: 4001: 3997: 3990: 3987: 3981: 3978: 3966: 3962: 3956: 3953: 3947: 3942: 3938: 3934: 3930: 3926: 3922: 3915: 3912: 3906: 3903: 3890: 3883: 3880: 3875: 3868: 3862: 3859: 3854: 3850: 3845: 3840: 3835: 3830: 3826: 3822: 3818: 3811: 3808: 3803: 3799: 3795: 3791: 3787: 3783: 3779: 3775: 3774:Lab on a Chip 3768: 3765: 3754:on 2015-09-04 3753: 3749: 3748: 3743: 3737: 3734: 3729: 3723: 3719: 3715: 3711: 3704: 3702: 3698: 3687: 3683: 3676: 3673: 3660: 3656: 3650: 3647: 3634: 3628: 3625: 3612: 3606: 3603: 3590: 3586: 3582: 3576: 3573: 3561: 3557: 3551: 3549: 3545: 3533: 3529: 3523: 3520: 3508: 3504: 3498: 3495: 3487: 3486: 3478: 3475: 3470: 3466: 3462: 3455: 3452: 3447: 3441: 3437: 3430: 3427: 3416:on 2020-03-17 3415: 3411: 3407: 3401: 3398: 3393: 3389: 3385: 3378: 3375: 3370: 3366: 3362: 3358: 3354: 3350: 3346: 3342: 3335: 3332: 3327: 3323: 3319: 3315: 3311: 3307: 3303: 3299: 3292: 3289: 3283: 3280: 3275: 3271: 3266: 3261: 3257: 3253: 3249: 3245: 3241: 3234: 3231: 3226: 3222: 3221: 3216: 3209: 3206: 3201: 3197: 3193: 3189: 3185: 3181: 3174: 3171: 3166: 3162: 3158: 3154: 3150: 3146: 3139: 3136: 3124: 3117: 3114: 3102: 3095: 3092: 3080: 3074: 3071: 3058: 3054: 3048: 3045: 3032: 3028: 3022: 3019: 3003: 2997: 2994: 2982: 2975: 2969: 2966: 2954: 2950: 2943: 2940: 2927: 2923: 2917: 2914: 2902: 2898: 2892: 2889: 2877: 2873: 2867: 2864: 2853:on 2018-11-10 2852: 2848: 2844: 2838: 2835: 2823: 2816: 2810: 2807: 2795: 2789: 2787: 2783: 2775: 2771: 2764: 2758: 2755: 2750: 2748:9789814669115 2744: 2741:. CRC Press. 2740: 2733: 2730: 2717: 2711: 2708: 2702: 2699: 2694: 2688: 2684: 2678: 2675: 2667: 2660: 2657: 2652: 2648: 2642: 2639: 2627: 2623: 2617: 2615: 2613: 2611: 2609: 2605: 2593: 2589: 2583: 2580: 2567: 2563: 2557: 2554: 2542: 2538: 2532: 2530: 2528: 2524: 2519: 2515: 2510: 2505: 2500: 2495: 2491: 2487: 2483: 2476: 2473: 2469:. 2 May 2023. 2468: 2462: 2459: 2446: 2440: 2437: 2421: 2415: 2413: 2409: 2405:. 2008-07-11. 2404: 2400: 2394: 2391: 2386: 2384:9789814411226 2380: 2377:. CRC Press. 2376: 2369: 2367: 2363: 2350: 2344: 2341: 2336: 2330: 2326: 2325: 2317: 2314: 2301: 2297: 2291: 2288: 2275: 2269: 2266: 2254: 2250: 2244: 2241: 2228: 2222: 2219: 2214: 2212:9780323265638 2208: 2204: 2197: 2194: 2181: 2175: 2172: 2159: 2153: 2150: 2145: 2139: 2136: 2130: 2126: 2123: 2121: 2118: 2116: 2115:Pharmacopoeia 2113: 2111: 2108: 2106: 2103: 2101: 2098: 2096: 2093: 2091: 2088: 2086: 2083: 2081: 2078: 2076: 2073: 2071: 2068: 2066: 2063: 2061: 2058: 2056: 2053: 2051: 2048: 2046: 2043: 2041: 2038: 2036: 2033: 2032: 2028: 2023: 2019: 2016: 2013: 2010: 2007: 2004: 2001: 1998: 1995: 1992: 1991: 1987: 1983: 1982: 1978: 1976: 1975: 1971: 1970: 1966: 1964: 1960: 1956: 1953: 1949: 1945: 1940: 1939:global health 1932: 1930: 1928: 1924: 1919: 1917: 1913: 1905: 1903: 1899: 1896: 1892: 1888: 1886:in the blood. 1885: 1881: 1877: 1873: 1869: 1866: 1862: 1858: 1854: 1851: 1848: 1844: 1840: 1836: 1832: 1828: 1824: 1820: 1817: 1814: 1810: 1806: 1802: 1799: 1795: 1791: 1787: 1783: 1779: 1775: 1772: 1771: 1770: 1764: 1762: 1760: 1756: 1752: 1751:armamentarium 1748: 1740: 1730: 1727: 1719: 1708: 1705: 1701: 1698: 1694: 1691: 1687: 1684: 1680: 1677: – 1676: 1672: 1671:Find sources: 1665: 1661: 1655: 1654: 1649:This article 1647: 1643: 1638: 1637: 1633: 1625: 1623: 1621: 1612: 1610: 1608: 1607:cybersecurity 1603: 1601: 1597: 1591: 1589: 1585: 1581: 1577: 1573: 1569: 1565: 1561: 1557: 1551: 1544:Cybersecurity 1543: 1541: 1537: 1536:development. 1535: 1530: 1522: 1519: 1511: 1509: 1505: 1501: 1496: 1488: 1485: 1477: 1475: 1473: 1465: 1461: 1459: 1455: 1453: 1449: 1448: 1447: 1444: 1437: 1432: 1429: 1428: 1424: 1422: 1420: 1416: 1413:is part of a 1412: 1406: 1402: 1400: 1396: 1393: 1391: 1388:ASTM F2097 – 1387: 1386: 1385: 1383: 1379: 1370: 1363: 1361: 1359: 1355: 1350: 1346: 1343: 1338: 1334: 1332: 1328: 1323: 1321: 1320: 1315: 1311: 1307: 1303: 1298: 1296: 1291: 1289: 1285: 1281: 1277: 1273: 1269: 1265: 1260: 1259:ISO 9001:2008 1256: 1252: 1248: 1244: 1240: 1232: 1230: 1226: 1224: 1223:medical tests 1220: 1216: 1211: 1203: 1201: 1198: 1196: 1191: 1189: 1184: 1181: 1176: 1168: 1161: 1158: 1155: 1154: 1150: 1147: 1144: 1143: 1139: 1136: 1133: 1132: 1128: 1125: 1122: 1121: 1117: 1114: 1111: 1110: 1107: 1103: 1101: 1093: 1091: 1089: 1085: 1077: 1074: 1071: 1068: 1067: 1066: 1063: 1060: 1059:Health Canada 1053: 1049: 1045: 1044:Spinal boards 1041: 1034: 1027: 1024: 1023: 1019: 1016: 1015: 1011: 1008: 1007: 1004:Low - medium 1003: 1000: 999: 995: 992: 991: 987: 984: 983: 977: 975: 967: 965: 958: 956: 947: 944: 943: 939: 936: 935: 931: 928: 927: 923: 920: 919: 915: 912: 911: 908: 902: 900: 897: 892: 887: 885: 881: 875: 873: 872:Notified Body 869: 863: 860: 856: 853: 849: 846: 842: 839: 835: 832: 828: 825: 816: 813: 810: 809: 805: 802: 799: 798: 795:Hearing aids 794: 791: 788: 787: 783: 780: 777: 776: 772: 769: 766: 765: 762: 760: 759: 754: 746: 744: 742: 736: 734: 729: 725: 723: 713: 710: 707: 704: 703: 699: 696: 693: 690: 689: 685: 682: 679: 676: 675: 671: 668: 665: 662: 661: 655: 652: 649: 648: 647: 645: 641: 630: 620: 616: 615:summary style 612: 606: 602: 600: 596:This section 594: 585: 584: 580: 574: 567:United States 566: 561: 559: 555: 553: 544: 539: 532: 527: 525: 515: 512: 504: 494: 490: 486: 480: 479: 475: 470:This section 468: 464: 459: 458: 452: 450: 447: 446:Health Canada 442: 440: 436: 429: 425: 421: 416: 409: 404: 402: 400: 392: 387: 383: 380: 376: 375: 374: 371: 368: 366: 365:Notified Body 362: 358: 354: 349: 347: 343: 338: 331: 327: 323: 320: 317: 316: 315: 312: 310: 306: 303:Based on the 298: 296: 294: 293:immunological 286: 283: 280: 277: 276: 275: 268: 266: 259: 257: 253: 250: 246: 242: 241: 240: 238: 230: 225: 223: 221: 217: 213: 208: 198: 191: 189: 185: 183: 179: 175: 171: 167: 163: 159: 155: 151: 147: 142: 140: 136: 132: 128: 124: 120: 116: 112: 100: 97: 93: 84: 76: 68: 58: 46: 41: 32: 31: 19: 4964: 4944:. 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Retrieved 2152: 2138: 2125:Telemedicine 1979: 1972: 1961: 1957: 1936: 1920: 1909: 1822: 1819:Life support 1768: 1750: 1746: 1745: 1722: 1716:January 2008 1713: 1703: 1696: 1689: 1682: 1670: 1658:Please help 1653:verification 1650: 1616: 1604: 1592: 1553: 1538: 1526: 1506: 1502: 1498: 1468: 1463: 1462:ASTM F3208: 1457: 1456:ASTM D7225: 1451: 1450:ASTM E2314: 1445: 1441: 1409: 1404: 1398: 1389: 1375: 1351: 1347: 1339: 1335: 1324: 1317: 1299: 1292: 1236: 1227: 1213: 1199: 1192: 1185: 1178: 1104: 1097: 1090:(Class IV). 1084:hemodialysis 1081: 1064: 1056: 971: 962: 953: 906: 888: 876: 870:issued by a 864: 858: 857: 851: 850: 844: 843: 837: 836: 830: 829: 823: 822: 792:Medium Risk 756: 750: 737: 730: 726: 719: 694:Medium Risk 637: 624: 597: 556: 548: 522: 507: 498: 483:Please help 471: 443: 432: 396: 372: 369: 350: 341: 339: 337:2007/47 EC. 335: 325: 313: 309:New Approach 308: 305:New Approach 304: 302: 290: 272: 263: 255: 234: 203: 186: 143: 101: 91: 89: 52: 44: 5016:Health care 4810:www.epa.gov 4785:www.epa.gov 4589:14 November 4276:17 February 4225:29 December 4194:29 December 4057:: 454–462. 4023:10016/26173 4006:: 272–289. 3931:: 959–979. 3925:IEEE Access 3895:17 February 2926:www.iso.org 2722:13 December 2492:(1): 3–11. 1580:human error 1264:IEC 60601-1 1190:standards. 642:, the U.S. 543:stethoscope 125:. 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