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11.100.20 Biologické hodnocení zdravotnických prostředků

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BS EN ISO 10993-7:2008+A1:2022
Biological evaluation of medical devices Ethylene oxide sterilization residuals

Vydáno: 2022-01-26

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BS EN ISO 20776-1:2020
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

Vydáno: 2024-05-08

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

Vydáno: 2020-12-21

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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 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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PD ISO/TR 10993-55:2023
Biological evaluation of medical devices Interlaboratory study on cytotoxicity

Vydáno: 2023-02-20

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BS EN ISO 10993-10:2023
Biological evaluation of medical devices Tests for skin sensitization

Vydáno: 2023-02-08

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

Vydáno: 2009-07-31

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

Vydáno: 2020-02-24

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