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About This Item
Full Description
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the medical device;
— the assessment of the biological safety of the medical device.
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 10993-1:2020
viewing
Biological evaluation of medical devices-Evaluation and testing within a risk management process- Most Recent
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BS EN ISO 10993-1:OCTOBER 2009
Biological evaluation of medical devices-Evaluation and testing within a risk management process- Historical Version
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BS EN ISO 10993-1:2009
Biological evaluation of medical devices-Evaluation and testing within a risk management process- Historical Version
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BS EN ISO 10993-1:JUNE 2009
Biological evaluation of medical devices-Evaluation and testing- Historical Version
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BS EN ISO 10993-1 Draft
Biological evaluation of medical devices. Evaluation and testing within a risk management process- Historical Version
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BS 06/30106186 DC
ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management system- Historical Version
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BS EN ISO 10993-1:2003
Biological evaluation of medical devices-Evaluation and testing- Historical Version
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BS EN ISO 10993-1:1998
Biological evaluation of medical devices-Evaluation and testing- Historical Version
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BS EN 30993-1:1994
Biological evaluation of medical devices-Guidance on selection of tests- Historical Version
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BS 5736-1:1989
Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test- Historical Version
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BS 5828:1989
Methods for biological assessment of dental materials- Historical Version
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BS 5736-1:1979
Evaluation of medical devices for biological hazards-Guide for the selection of biological methods of test- Historical Version
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BS 5828:1980
Methods of biological assessment of dental materials- Historical Version