Committee
|
CH/172/7 |
Development Note
|
Supersedes 01/561619 DC (05/2003) Supersedes 14/30295064 DC. (09/2015) |
Document Type
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Standard |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
British Standards Institution
|
Status
|
Withdrawn |
Superseded By
|
|
Supersedes
|
|
ISO 11137-1:2006
|
Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 10993-2:2006
|
Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 14630:2012
|
Non-active surgical implants General requirements |
EN 1041:2008+A1:2013
|
Information supplied by the manufacturer of medical devices |
ISO 13408-1:2008
|
Aseptic processing of health care products — Part 1: General requirements |
ISO 20857:2010
|
Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
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 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
ISO 10993-6:2016
|
Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
ISO 17665-1:2006
|
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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