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PD ISO/TR 15499:2012

Заменен
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 10993-7:2008/Cor.1:2009
Действует
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals -- Technical Corrigendum 1 — 2 стр.
ISO 10993-9:2009
Действует
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products — 16 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 10993-13:2010
Действует
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices — 22 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
ISO 10993-15:2000
Действует
Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys — 20 стр.
ISO 10993-16:2010
Заменен
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables — 18 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
PD ISO/TR 15499:2016
Действует
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.

На этот документ ссылаются

PD ISO/TR 15499:2016
Действует
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process — 24 стр.