11.100.20 : Biological evaluation of medical devices

NF EN ISO 10993-11, S99-501-11 (05/2018)

NF EN ISO 10993-11, S99-501-11 (05/2018)

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Biological evaluation of medical devices - Part 11 : tests for systemic toxicity

€117.00

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NF EN ISO 20776-2, S92-053-2 (10/2007)

NF EN ISO 20776-2, S92-053-2 (10/2007)

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Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2 : evaluation of performance of antimicrobial susceptibility test devices - Systèmes d'essais en laboratoire et de diagnostic in vitro

€51.24

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NF EN ISO 10993-18, S99-501-18 (05/2020)

NF EN ISO 10993-18, S99-501-18 (05/2020)

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Biological evaluation of medical devices - Part 18 : chemical characterization of medical device materials within a risk management process

€167.33

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NF EN ISO 10993-13, S99-501-13 (09/2010)

NF EN ISO 10993-13, S99-501-13 (09/2010)

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Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices

€82.00

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NF EN ISO 10993-9, S99-501-9 (05/2010)

NF EN ISO 10993-9, S99-501-9 (05/2010)

Superseded Historical

Biological evaluation of medical devices - Part 9 : framework for identification and quantification of potential degradation products

€62.33

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NF EN ISO 10993-1, S99-501-1 (07/2010)

NF EN ISO 10993-1, S99-501-1 (07/2010)

Superseded Historical

Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process

€89.33

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NF EN ISO 14155, S99-201 (05/2012)

NF EN ISO 14155, S99-201 (05/2012)

Superseded Historical

Clinical investigation of medical devices for human subjects - Good clinical practice - Investigation clinique des dispositifs médicaux pour sujets humains

€152.67

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NF EN ISO 10993-3, S99-501-3 (12/2014)

NF EN ISO 10993-3, S99-501-3 (12/2014)

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Biological evaluation of medical devices - Part 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity

€117.00

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NF EN ISO 10993-7, S99-501-7 (12/2008)

NF EN ISO 10993-7, S99-501-7 (12/2008)

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Biological evaluation of medical devices - Part 7 : ethylene oxide sterilization residuals

€181.00

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NF EN ISO 10993-5, S99-501-5 (07/2010)

NF EN ISO 10993-5, S99-501-5 (07/2010)

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Biological evaluation of medical devices - Part 5 : tests for in vitro cytotoxicity

€107.33

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NF EN ISO 10993-2, S99-502 (12/2006)

NF EN ISO 10993-2, S99-502 (12/2006)

Superseded Historical

Biological evaluation of medical devices - Part 2 : animal welfare requirements

€78.00

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UNE-EN ISO 10993-18:2021

UNE-EN ISO 10993-18:2021

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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

€132.00

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UNE-EN ISO 20776-1:2021

UNE-EN ISO 20776-1:2021

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Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12)

€75.00

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UNE-EN ISO 10993-23:2021

UNE-EN ISO 10993-23:2021

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Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

€129.00

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UNE-EN ISO 22442-1:2022

UNE-EN ISO 22442-1:2022

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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

€91.00

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