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DIN 58934-1:1997-12
Действует
Haematology - Control material for the CBC - Part 1: Control bloods — 3 стр.
DIN EN ISO 7405:2019-03
Действует
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12); German version EN ISO 7405:2018 — 56 стр.
DIN EN 13532:2002-08
Действует
General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts — 11 стр.
DIN EN 13612:2002-08
Действует
Performance evaluation of in vitro diagnostic medical devices; German version EN 13612:2002, German and English texts — 20 стр.
DIN EN 13641:2002-08
Действует
Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts — 11 стр.
DIN EN ISO 10993-2:2006-10
Действует
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); German version EN ISO 10993-2:2006 — 20 стр.
DIN EN ISO 10993-3:2015-02
Действует
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 — 48 стр.
DIN EN ISO 10993-4:2017-12
Действует
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017); German version EN ISO 10993-4:2017 — 93 стр.
DIN EN ISO 10993-5:2009-10
Действует
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 — 46 стр.
DIN EN ISO 10993-7:2009-02
Действует
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008 — 108 стр.
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); Corrigendum 1 to English translation of DIN EN ISO 10993-7:2009-02 — 3 стр.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013 — 83 стр.
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018 — 49 стр.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012 — 33 стр.
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010); German version EN ISO 10993-13:2010 — 26 стр.
DIN EN 13975:2003-11
Действует
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts — 19 стр.
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2009 — 23 стр.
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000); German version EN ISO 10993-15:2009 — 21 стр.
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017 — 26 стр.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 — 38 стр.
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