Comment Closes On
|
|
Committee
|
CH/150/2 |
Document Type
|
Draft |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
British Standards Institution
|
Status
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Withdrawn |
ISO 11135:2014
|
Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 13488:1996
|
Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
ISO 8637:2010
|
Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
ISO 10993-11:2017
|
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ISO 10993-7:2008
|
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 11134:1994
|
Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
ISO 11137:1995
|
Sterilization of health care products Requirements for validation and routine control Radiation sterilization |
ISO 594-2:1998
|
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
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