ÖNORM 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)

Описание Изменения Ссылки Версии

Ссылочные документы

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 10993-2:2006

Действует

Biological evaluation of medical devices -- Part 2: Animal welfare requirements — 20 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 11070:1998

Заменен

Sterile single-use intravascular catheter introducers — 26 стр.

ISO 11607-1:2006

Действует

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems — 32 стр.

ISO 14155:2011

Действует

Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.

ISO 14630:2012

Действует

Non-active surgical implants -- General requirements — 20 стр.

ISO 14937:2009

Действует

Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices — 46 стр.

ISO 14971:2007

Действует

Medical devices -- Application of risk management to medical devices — 90 стр.

ISO 15223-1:2012

Заменен

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements — 30 стр.

ISO 25539-2:2012

Действует

Cardiovascular implants -- Endovascular devices -- Part 2: Vascular stents — 98 стр.