08/30179589 DC : DRAFT MAR 2008
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS ISO 15674 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD-SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFT VENOUS RESERVOIR BAGS
Superseded date
11-30-2009
Superseded by
Published date
11-23-2012
Publisher
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| Committee |
CH/150/2
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| 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 14937:2009 | 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 |
| ISO/TS 23810:2012 | Cardiovascular implants and artificial organs Checklist for preoperative extracorporeal circulation equipment setup |
| ISO 7199:2016 | Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
| 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 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 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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