Comment Closes On
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Committee
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CH/78/7 |
Document Type
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Draft |
ISBN
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|
Pages
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Published
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|
Publisher
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British Standards Institution
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Status
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Superseded |
Superseded By
|
|
AAMI TIR19 : 1998
|
GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
ISO 14155-2:2003
|
Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
EN 868-1 : 1997
|
PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS |
ISO 14155-1:2003
|
Clinical investigation of medical devices for human subjects Part 1: General requirements |
ISO 10993-2:2006
|
Biological evaluation of medical devices — Part 2: Animal welfare requirements |
ISO 14630:2012
|
Non-active surgical implants General requirements |
EN 1041:2008+A1:2013
|
Information supplied by the manufacturer of medical devices |
ISO 10993-18:2005
|
Biological evaluation of medical devices Part 18: Chemical characterization of materials |
ISO 13408-1:2008
|
Aseptic processing of health care products — Part 1: General requirements |
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 11607:2003
|
Packaging for terminally sterilized medical devices |
ISO 14971-1:1998
|
Medical devices Risk management Part 1: Application of risk analysis |
ISO 10993-6:2016
|
Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
ISO 15223:2000
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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