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BS EN ISO 7199:2014

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

Ссылочные документы

ISO 10993-18:2005
Действует
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials — 24 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 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
ISO 11137-1:2006
Действует
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices — 44 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 11607-2:2006
Действует
Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes — 18 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 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 13485:2016
Действует
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 46 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
ISO/TS 23810:2012
Заменен
Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup — 18 стр.
BS EN ISO 7199:2017
Действует
Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 28 стр.

На этот документ ссылаются

BS EN ISO 7199:2017
Действует
Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators) — 28 стр.