BS EN ISO 23908:2013
Current
The latest, up-to-date edition.
Sharps injury protection. Requirements and test methods. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Hardcopy , PDF
English
28-02-2013
Important note : All end users must be registered with an Account prior to user licenses being assigned.| Committee |
CH/84
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| DevelopmentNote |
Supersedes 09/30186527 DC. (06/2011)
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| DocumentType |
Standard
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| Pages |
22
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.
| Standards | Relationship |
| EN ISO 23908:2013 | Identical |
| ISO 23908:2011 | Identical |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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