52:(FDA) review division for more information is possible. The table "Endpoints to be addressed in a biological risk assessment" was revised by the 2018 edition of ISO 10993-1. The selection of endpoints for the biocompatibility evaluation is determined by the nature of body contact (e.g. implant device) and contact duration (e.g. long term contact of more than 30 days).
47:
The following table provides a framework for the development of a biocompatibility evaluation. Different biological endpoints may require evaluation for particular medical devices, including either additional or fewer endpoints than indicated. If it is unclear in which category a device falls,
31:
to manage biological risk. These documents were preceded by the
Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of
1284:
1244:
1245:"Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)"
39:
is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
49:
1289:
1279:
1219:
1177:
Part 13: Identification and quantification of degradation products from polymeric medical devices
1192:
Part 18: Chemical characterization of medical device materials within a risk management process
24:
1183:
Part 15: Identification and quantification of degradation products from metals and alloys
1165:
Part 9: Framework for identification and quantification of potential degradation products
32:
28:
1195:
Part 19: Physico-chemical, morphological and topographical characterization of materials
1273:
1202:
1180:
Part 14: Identification and quantification of degradation products from ceramics
1198:
Part 20: Principles and methods for immunotoxicology testing of medical devices
1174:
Part 12: Sample preparation and reference materials (available in
English only)
1225:
ISO Standards catalogue: 11.100.20 - Biological evaluation of medical devices
1186:
Part 16: Toxicokinetic study design for degradation products and leachables
1147:
Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
1224:
48:
consulting device-specific guidances or contacting the appropriate US
1189:
Part 17: Establishment of allowable limits for leachable substances
1141:
Part 1: Evaluation and testing within a risk management process
1125:
X = ISO 10993-1:2009 recommended endpoints for consideration
16:
Standards for evaluating biocompatibility of medical devices
1130:
O = Additional FDA recommended endpoints for consideration
35:. For the purpose of the ISO 10993 family of standards,
1150:
Part 4: Selection of tests for interactions with blood
43:
ISO 10993-1:2009 & FDA endpoints for consideration
1162:
Part 8: Selection of reference materials (withdrawn)
23:
set entails a series of standards for evaluating the
1210:
Part 33: Guidance on tests to evaluate genotoxicity
1156:Part 6: Tests for local effects after implantation
1159:Part 7: Ethylene oxide sterilization residuals
8:
1153:Part 5: Tests for in vitro cytotoxicity.
1137:List of the standards in the 10993 series
96:Irritation or Intracutaneous Reactivity
54:
1236:
1168:Part 10: Tests for skin sensitization
1171:Part 11: Tests for systemic toxicity
7:
1144:Part 2: Animal welfare requirements
123:Reproductive/Developmental Toxicity
14:
58:Medical device categorization by
362:Breached or compromised surface
102:Material-Mediated Pyrogenicity
1207:Part 23: Tests for irritation
480:External communicating device
1:
1285:Regulation of medical devices
105:Subacute/Subchronic Toxicity
50:Food and Drug Administration
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99:Acute Systemic Toxicity
66:Nature of Body Contact
1220:List of ISO standards
1201:Part 22: Guidance on
483:Blood path, indirect
603:Tissue/bone/dentin
80:(>24 h to 30 d)
722:Circulating blood
114:Hemocompatibility
61:Biological Effect
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247:Mucosal membrane
117:Chronic Toxicity
69:Contact Duration
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120:Carcinogenicity
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37:biocompatibility
25:biocompatibility
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1290:Medical devices
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845:Implant device
139:Surface device
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33:medical devices
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111:Implantation
108:Genotoxicity
90:Cytotoxicity
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1256:. Retrieved
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1140:
848:Tissue/bone
142:Intact skin
126:Degradation
86:(> 30 d)
85:
83:C-permanent
82:
79:
77:B-prolonged
76:
73:
70:
46:
36:
20:
18:
1274:Categories
1258:23 January
1231:References
71:A-limited
131:Category
21:ISO 10993
1214:See also
134:Contact
74:(≤24 h)
1252:fda.gov
967:Blood
1254:. FDA
1248:(PDF)
1260:2017
19:The
27:of
1276::
1250:.
1082:O
1079:O
1076:X
1073:X
1070:X
1067:X
1064:O
1061:X
1058:X
1055:X
1052:X
1049:C
1036:X
1033:X
1030:X
1027:X
1024:O
1021:X
1018:X
1015:X
1012:X
1009:B
996:X
993:X
990:O
985:O
982:X
979:X
976:X
973:X
970:A
958:O
955:O
950:X
947:X
944:X
941:O
938:X
935:X
932:X
929:X
926:C
911:X
908:X
905:X
902:O
899:X
896:X
893:X
890:X
887:B
866:O
863:O
860:X
857:X
854:X
851:A
836:O
833:O
830:X
827:X
824:X
821:X
818:O
815:X
812:X
809:X
806:X
803:C
790:X
787:X
784:X
781:X
778:O
775:X
772:X
769:X
766:X
763:B
750:X
745:O
740:O
737:X
734:X
731:X
728:X
725:A
713:O
710:O
705:X
702:X
699:X
696:O
693:X
690:X
687:X
684:X
681:C
666:X
663:X
660:X
657:O
654:X
651:X
648:X
645:X
642:B
621:O
618:O
615:X
612:X
609:X
606:A
594:O
591:O
588:X
585:O
582:X
579:X
576:O
573:X
570:O
567:X
564:X
561:C
550:X
541:O
538:O
535:X
532:X
529:X
526:X
523:B
512:X
501:O
498:X
495:X
492:X
489:X
486:A
471:O
468:O
463:O
460:X
457:X
454:O
451:O
448:X
445:X
442:X
439:C
424:O
419:O
416:O
413:O
410:X
407:X
404:X
401:B
380:O
377:O
374:X
371:X
368:X
365:A
351:O
346:O
343:X
340:X
337:O
334:O
331:X
328:X
325:X
322:C
307:O
302:O
299:O
296:O
293:X
290:X
287:X
284:B
259:X
256:X
253:X
250:A
222:X
219:X
216:X
213:C
188:X
185:X
182:X
179:B
154:X
151:X
148:X
145:A
1262:.
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