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Homepage>BSI Standards>11 ZDRAVOTNÍ TECHNIKA>11.100 Laboratorní lékařství>11.100.20 Biologické hodnocení zdravotnických prostředků

11.100.20 Biologické hodnocení zdravotnických prostředků

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BS ISO 17593:2022 - TC
Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Vydáno: 2022-03-28
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BS ISO 17593:2022
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Vydáno: 2022-03-15
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DD ISO/TS 10993-20:2006
Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices
Vydáno: 2006-09-29
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PD ISO/TR 10993-22:2017
Biological evaluation of medical devices Guidance on nanomaterials
Vydáno: 2017-07-19
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PD ISO/TR 10993-33:2015
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
Vydáno: 2015-03-31
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PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity
Vydáno: 2023-02-20
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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
Vydáno: 2020-02-26
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PD ISO/TR 15499:2016
Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
Vydáno: 2017-01-31
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PD ISO/TR 21582:2021
Pyrogenicity. Principles and methods for pyrogen testing of medical devices
Vydáno: 2021-07-28
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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
Vydáno: 2011-02-28
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PD ISO/TS 10993-19:2020
Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
Vydáno: 2020-03-16
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PD ISO/TS 11796:2023
Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
Vydáno: 2023-08-02
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50 results
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