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ÖVE/ÖNORM EN ISO 13485:2016-07

Заменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 9000:2015
Действует
Quality management systems -- Fundamentals and vocabulary — 58 стр.
ÖVE/ÖNORM EN ISO 13485:2017-08
Заменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)
ÖNORM EN ISO 13485:2012-11
Заменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

На этот документ ссылаются

DIN EN ISO 22442-1:2008-03
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); German version EN ISO 22442-1:2007 — 36 стр.
DIN EN ISO 22442-2:2008-03
Отменен
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); German version EN ISO 22442-2:2007 — 23 стр.
DIN EN 285:2009-08
Отменен
Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2006+A2:2009 — 89 стр.
DIN EN ISO 4074:2002-07
Отменен
Natural latex condoms - Requirements and test methods (ISO 4074:2002); German version EN ISO 4074:2002 — 53 стр.
DIN EN ISO 4074:2016-05
Отменен
Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015); German version EN ISO 4074:2015 — 73 стр.
DIN EN ISO 5840-2:2015-12
Отменен
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015 — 71 стр.
ÖNORM EN ISO 13485:2012-11
Заменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)
ÖVE/ÖNORM EN ISO 13485:2017-08
Заменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)