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ISO 13485:2003/Cor.1:2009

Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes -- Technical Corrigendum 1 — 2 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.

На этот документ ссылаются

BS ISO 8009-1:1997
Действует
Reusable rubber contraceptive diaphragms. Classification, sampling and requirements — 12 стр.
BS ISO 7199:2009+A1:2012
Действует
Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 22 стр.
BS EN ISO 11140-1:2009
Заменен
Sterilization of health care products. Chemical indicators. General requirements — 38 стр.
BS EN 60601-1:2006
Заменен
Medical electrical equipment. General requirements for basic safety and essential performance — 384 стр.
DD ISO/TS 12417:2011
Действует
Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products — 60 стр.
BS EN ISO 14534:2011
Заменен
Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements — 20 стр.
BS ISO 13408-7:2012
Действует
Aseptic processing of health care products. Alternative processes for medical devices and combination products — 30 стр.
BS EN ISO 15197:2013
Заменен
In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus — 60 стр.
BS EN ISO 11137-2:2013
Заменен
Sterilization of health care products. Radiation. Establishing the sterilization dose — 82 стр.
BS EN ISO 13408-1:2011+A1:2013
Заменен
Aseptic processing of health care products. General requirements — 60 стр.
BS EN ISO 5840:2009
Заменен
Cardiovascular implants. Cardiac valve prostheses — 96 стр.
BS EN ISO 22442-2:2007
Заменен
Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling — 28 стр.
BS ISO 15674:2009
Действует
Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags — 18 стр.
BS ISO 15675:2009
Действует
Cardiovascular implants and artificial organs. Cardiopulmonary bypass systems. Arterial blood line filters — 18 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
ISO 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
BS EN ISO 12870:2012
Заменен
Ophthalmic optics. Spectacle frames. Requirements and test methods — 40 стр.
ÖNORM EN ISO 11135:2014-10
Заменен
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
ÖNORM EN ISO 11608-1:2012-12
Заменен
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2012)
ÖNORM EN ISO 11135-1:2007-08
Заменен
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
ÖNORM EN ISO 13408-1:2014-01
Заменен
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013) (consolidated version)
ÖNORM EN ISO 11137-1:2013-12
Заменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006 + Amd 1:2013) (consolidated version)
ÖNORM EN ISO 15197:2013-12
Заменен
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
ÖNORM EN ISO 5840:2009-09
Заменен
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
ÖNORM CEN ISO/TS 11135-2:2011-01
Заменен
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008 + Cor 1:2009) (consolidated version)