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СтандартыBSI

18/30358832 DC

Действует
BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process — 71 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 стр.
ISO 10993-1:2018
Действует
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 48 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 10993-14:2001
Действует
Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics — 18 стр.
ISO 10993-17:2002
Действует
Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances — 31 стр.
ISO 5725-1:1994
Действует
Accuracy (trueness and precision) of measurement methods and results. Part 1. General principles and definitions — 24 стр.
BS ISO 5832-14:2007
Действует
Implants for surgery. Metallic materials. Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy — 12 стр.
ISO 22442-3:2007
Действует
Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents — 30 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 10993-13:2010
Действует
Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices — 22 стр.
ISO 22442-2:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling — 24 стр.
ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 22442-1:2007
Заменен
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management — 34 стр.
BS EN 455-3:2015
Действует
Medical gloves for single use. Requirements and testing for biological evaluation — 38 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.