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ÖNORM EN ISO 10993-16:2010-06

Заменен
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 10993-2:2006
Действует
Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 стр.
ISO 10993-12:2012
Действует
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials — 28 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 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO 10993-1:2009/Cor.1:2010
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process -- Technical Corrigendum 1 — 1 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ÖNORM EN ISO 10993-16:2018-01
Действует
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

На этот документ ссылаются

DIN EN ISO 25539-2:2009-08
Отменен
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008); German version EN ISO 25539-2:2009 — 124 стр.
DIN ISO 13022:2014-06
Действует
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012) — 62 стр.
DIN EN ISO 7405:2009-06
Отменен
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008); German version EN ISO 7405:2008 — 44 стр.
DIN EN ISO 12417-1:2016-02
Действует
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) — 71 стр.
ÖNORM EN 455-3:2007-03
Заменен
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
ÖVE/ÖNORM EN 60601-1:2014-02
Действует
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
ÖNORM EN ISO 10993-16:2018-01
Действует
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)