11.100.20 Biological evaluation of medical devices

Displaying 121-132 of 155 results.

LVS EN ISO 14155-1:2009

standard

EN
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
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18.53 €

LVS EN ISO 14155:2011

standard

EN
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
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26.12 €

LVS EN ISO 14155:2011 /AC:2011

corrigendum

EN
Clinical investigation of medical devices for human subjects - Good clinical practice - Technical Corrigendum 1 (ISO 14155:2011/Cor 1:2011)
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0.00 €

LVS EN ISO 14155:2020

standard

EN
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
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29.76 €

LVS EN ISO 14155:2020/A11:2025

amendment

EN
Clinical investigation of medical devices for human subjects - Good clinical practice
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13.05 €

LVS EN ISO 14155-2:2009

standard

EN
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
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13.05 €

ISO/TR 15499:2012

technical report (TR)

EN
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
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68.85 €

ISO/TR 15499:2016

technical report (TR)

EN
Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process
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68.85 €

ISO/TS 16782:2016

technical specification (TS)

EN
Clinical laboratory testing Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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139.82 €

ISO 17593:2007

standard

EN
Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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68.85 €

ISO 17593:2022

standard

EN
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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210.78 €

ISO 20776-1:2006

standard

EN
Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices
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68.85 €