BS EN ISO 10993-3:2014
$189.07
Biological evaluation of medical devices – Tests for genotoxicity, carcinogenicity and reproductive toxicity
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 48 |
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices:
-
genotoxicity;
-
carcinogenicity;
-
reproductive and developmental toxicity.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Foreword |
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices |
| 7 | Annex ZB (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices Table ZB.1 — Correspondence between this European Standard and Directive 90/385/EEC on active implantable medical devices |
| 9 | Foreword |
| 11 | Introduction |
| 12 | Section sec_1 Section sec_2 1 Scope 2 Normative references |
| 13 | Section sec_3 Section sec_3.1 Section sec_3.2 Section sec_3.3 Section sec_3.4 Section sec_3.5 Section sec_3.6 Section sec_4 Section sec_4.1 3 Terms and definitions 4 Requirements for test strategies 4.1 General |
| 14 | Section sec_4.2 Section sec_4.3 4.2 Additional requirements for carcinogenicity testing 4.3 Additional requirements for reproductive toxicity testing |
| 15 | Section sec_5 Section sec_5.1 Section sec_5.2 Section sec_5.2.1 Section sec_5.2.2 5 Genotoxicity tests 5.1 General 5.2 Test strategy |
| 16 | Section sec_5.2.3 |
| 17 | Section sec_5.3 5.3 Sample preparation |
| 18 | Section sec_6 Section sec_6.1 Section sec_6.2 6 Carcinogenicity tests 6.1 General 6.2 Evaluation strategy |
| 19 | Section sec_6.3 Section sec_6.4 6.3 Sample preparation 6.4 Test methods |
| 20 | Section sec_7 Section sec_7.1 Section sec_7.2 7 Reproductive and developmental toxicity tests 7.1 General 7.2 Test strategy |
| 21 | Section sec_7.3 Section sec_7.4 7.3 Sample preparation 7.4 Test methods |
| 22 | Section sec_8 8 Test report |
| 23 | Annex sec_A Annex sec_A.1 Annex A (informative) Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing |
| 24 | Annex sec_A.2 Annex sec_A.2.1 Annex sec_A.2.2 Annex sec_A.2.2.1 Annex sec_A.2.2.2 |
| 25 | Annex sec_A.2.2.3 Annex sec_A.2.3 Annex sec_A.3 Annex sec_A.3.1 |
| 26 | Figure fig_A.1 |
| 27 | Table tab_A.1 Annex sec_A.3.2 Annex sec_A.3.3 Annex sec_A.3.3.1 |
| 28 | Annex sec_A.3.3.2 Annex sec_A.3.3.3 |
| 29 | Annex sec_A.3.3.4 Annex sec_A.3.4 Annex sec_A.3.4.1 Annex sec_A.3.4.2 Annex sec_A.3.4.2.1 Annex sec_A.3.4.2.2 Annex sec_A.3.4.2.3 |
| 30 | Annex sec_A.3.4.2.4 Annex sec_A.3.4.2.5 Annex sec_A.4 Annex sec_A.4.1 Annex sec_A.4.2 Annex sec_A.4.3 |
| 31 | Annex sec_B Figure fig_B.1 Annex B (informative) Flowchart for follow-up evaluation |
| 32 | Annex sec_C Annex sec_C.1 Annex C (informative) Rationale of test systems |
| 33 | Annex sec_C.2 Annex sec_C.3 |
| 34 | Annex sec_D Annex D (informative) Cell transformation test systems |
| 35 | Annex sec_E Annex sec_E.1 Annex sec_E.2 Annex E (normative) Considerations for carcinogenicity studies performed as implantation studies |
| 36 | Annex sec_F Table tab_F.1 Annex F (informative) In vitro tests for embryo toxicity |
| 37 | Table tab_F.2 |
| 38 | Reference ref_1 Reference ref_2 Reference ref_3 Reference ref_4 Reference ref_5 Reference ref_6 Reference ref_7 Reference ref_8 Reference ref_9 Reference ref_10 Reference ref_11 Reference ref_12 Reference ref_13 Reference ref_14 Reference ref_15 Reference ref_16 Reference ref_17 Reference ref_18 Reference ref_19 Reference ref_20 Bibliography Bibliography |
| 39 | Reference ref_21 Reference ref_22 Reference ref_23 Reference ref_24 Reference ref_25 Reference ref_26 Reference ref_27 Reference ref_28 Reference ref_29 Reference ref_30 Reference ref_31 Reference ref_32 Reference ref_33 Reference ref_34 Reference ref_35 |
| 40 | Reference ref_36 Reference ref_37 Reference ref_38 Reference ref_39 Reference ref_40 Reference ref_41 Reference ref_42 Reference ref_43 Reference ref_44 Reference ref_45 Reference ref_46 Reference ref_47 Reference ref_48 Reference ref_49 Reference ref_50 Reference ref_51 Reference ref_52 |
| 41 | Reference ref_53 Reference ref_54 Reference ref_55 Reference ref_56 Reference ref_57 Reference ref_58 Reference ref_59 Reference ref_60 Reference ref_61 Reference ref_62 Reference ref_63 Reference ref_64 Reference ref_65 Reference ref_66 Reference ref_67 Reference ref_68 Reference ref_69 Reference ref_70 Reference ref_71 |
| 42 | Reference ref_72 Reference ref_73 Reference ref_74 Reference ref_75 Reference ref_76 Reference ref_77 Reference ref_78 Reference ref_79 Reference ref_80 Reference ref_81 Reference ref_82 Reference ref_83 Reference ref_84 Reference ref_85 Reference ref_86 Reference ref_87 |
| 43 | Reference ref_88 Reference ref_89 Reference ref_90 Reference ref_91 Reference ref_92 Reference ref_93 Reference ref_94 Reference ref_95 Reference ref_96 Reference ref_97 Reference ref_98 Reference ref_99 Reference ref_100 Reference ref_101 Reference ref_102 Reference ref_103 |
| 44 | Reference ref_104 Reference ref_105 Reference ref_106 Reference ref_107 Reference ref_108 Reference ref_109 Reference ref_110 Reference ref_111 Reference ref_112 Reference ref_113 Reference ref_114 Reference ref_115 Reference ref_116 Reference ref_117 Reference ref_118 Reference ref_119 Reference ref_120 Reference ref_121 |
| 45 | Reference ref_122 Reference ref_123 |
