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11.100.20 Biological evaluation of medical devices

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Released: 2015-12-31
BS EN ISO 22442-2:2015
Medical devices utilizing animal tissues and their derivatives Controls on sourcing, collection and handling
LANGUAGE
English
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Released: 2008-02-29
BS EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
LANGUAGE
English
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Released: 2018-11-28
BS EN ISO 7405:2018
Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
LANGUAGE
English
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Released: 2007-05-31
BS ISO 17593:2007
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
LANGUAGE
English
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Released: 2006-09-29
DD ISO/TS 10993-20:2006
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
LANGUAGE
English
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Released: 2017-07-19
PD ISO/TR 10993-22:2017
Biological evaluation of medical devices Guidance on nanomaterials
LANGUAGE
English
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Released: 2015-03-31
PD ISO/TR 10993-33:2015
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
LANGUAGE
English
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Released: 2020-02-26
PD ISO/TR 15499:2016 - TC
Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
LANGUAGE
English
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Released: 2017-01-31
PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
LANGUAGE
English
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Released: 2011-02-28
PD ISO/TR 22442-4:2010
Medical devices utilizing animal tissues and their derivatives Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
LANGUAGE
English
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Released: 2020-03-16
PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
LANGUAGE
English
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Released: 2016-11-30
PD ISO/TS 16782:2016
Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
LANGUAGE
English