Comment Closes On
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Committee
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CH/157 |
Document Type
|
Draft |
ISBN
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|
Pages
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|
Published
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|
Publisher
|
British Standards Institution
|
Status
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Current |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
ISO 188:2011
|
Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests |
ISO 16038:2005
|
Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms |
ISO 10993-10:2010
|
Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
ISO/TR 8550:1994
|
Guide for the selection of an acceptance sampling system, scheme or plan for inspection of discrete items in lots |
ISO 10993-11:2017
|
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 4074:2015
|
Natural rubber latex male condoms Requirements and test methods |
ISO 14971-1:1998
|
Medical devices Risk management Part 1: Application of risk analysis |
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
EN 980:2008
|
Symbols for use in the labelling of medical devices |
ISO 15223:2000
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied |
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