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About This Item
Full Description
BS EN ISO 10993-17:2009 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. BS EN ISO 10993-17:2009 does not address the potential for exposure from such sources.
Cross References:
ISO 10993-1
ISO 10993-7
ISO 14971
93/42/EEC
90/385/EEC
All current amendments available at time of purchase are included with the purchase of this document.
Document History
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BS EN ISO 10993-17:2023
Biological evaluation of medical devices-Toxicological risk assessment of medical device constituents- Most Recent
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BS EN ISO 10993-17:2009
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Biological evaluation of medical devices-Establishment of allowable limits for leachable substances- Historical Version
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BS EN ISO 10993-17:2002
Biological evaluation of medical devices-Establishment of allowable limits for leachable substances- Historical Version