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11.100.20 Biologické hodnocení zdravotnických prostředků

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BS EN ISO 10993-5:2009
Biological evaluation of medical devices Tests for in vitro cytotoxicity

Vydáno: 2009-07-31

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BS EN ISO 18812:2003
Health informatics. Clinical analyser interfaces to laboratory information systems. Use profiles

Vydáno: 2003-06-24

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BS EN ISO 10993-1:2020
Biological evaluation of medical devices Evaluation and testing within a risk management process

Vydáno: 2020-12-16

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BS EN ISO 10993-6:2016 - TC
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation

Vydáno: 2020-02-24

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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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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 EN ISO 10993-15:2023 - TC
Tracked Changes. Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys

Vydáno: 2023-05-26

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BS EN ISO 10993-13:2010
Biological evaluation of medical devices Identification and quantification of degradation products from polymeric medical devices

Vydáno: 2010-10-31

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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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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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24/30482498 DC
BS EN ISO 10993-23:2021/Amd 1 Biological evaluation of medical devices Part 23: Tests for irritation. AMENDMENT 1: Additional in vitro reconstructed human epidermis models

Vydáno: 2024-09-25

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BS EN ISO 10993-3:2014
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity

Vydáno: 2014-10-31

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