BS ISO 7199:2009+A1:2012

Действует

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 22 стр.

Ссылочные документы

ISO/TS 23810:2012

Заменен

Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup — 18 стр.

ISO 14971:2007

Действует

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

ISO 13485:2003/Cor.1:2009

Заменен

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

ISO 594-2:1998

Заменен

Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings — 16 стр.

ISO 17665-1:2006

Действует

Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices — 48 стр.

ISO 11607-2:2006

Действует

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes — 18 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 11137-1:2006/Amd.1:2013

Действует

Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 1 — 10 стр.

ISO 10993-11:2006

Заменен

Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 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 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.