11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
NF EN ISO 24998, B35-904 (03/2009)

NF EN ISO 24998, B35-904 (03/2009)

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Plastics laboratory ware - Single-use Petri dishes for microbiological procedures - Matériel de laboratoire en matière plastique

€51.24

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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Superseded Historical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 29701, T16-301 (08/2011)

NF EN ISO 29701, T16-301 (08/2011)

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Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test

€73.30

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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 12322/A1, S92-051/A1 (04/2002)

NF EN 12322/A1, S92-051/A1 (04/2002)

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In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media - Dispositifs médicaux de diagnostic in vitro

€28.00

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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 15195, S92-062 (09/2004)

NF EN ISO 15195, S92-062 (09/2004)

Superseded Historical

Laboratory medicine - Requirements for reference measurement laboratories - Médecine de laboratoires

€64.01

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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 22367:2020

UNE-EN ISO 22367:2020

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Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

€134.00

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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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UNE-EN ISO 22442-2:2022

UNE-EN ISO 22442-2:2022

Active Most Recent

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

€73.00

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