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
ISO/DIS 24884:2026

ISO/DIS 24884:2026

Active Most Recent

Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery

€77.00

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UNE-EN ISO 5649:2025

UNE-EN ISO 5649:2025

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Medical laboratories - Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests (ISO 5649:2024)

€96.00

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PR NF EN ISO 10993-2, S99-502PR (01/2025)

PR NF EN ISO 10993-2, S99-502PR (01/2025)

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Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives au bien-être animal

€96.00

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NBN EN ISO 22442-1:2021

NBN EN ISO 22442-1:2021

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

€124.00

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NBN EN ISO 10993-14:2009

NBN EN ISO 10993-14:2009

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Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)

€58.00

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NBN EN ISO 10993-16:2018

NBN EN ISO 10993-16:2018

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

€92.00

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NBN EN ISO 10993-1:2021

NBN EN ISO 10993-1:2021

Superseded Historical

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

€50.00

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NBN EN ISO 10993-9:2021

NBN EN ISO 10993-9:2021

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

€58.00

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NBN EN ISO 10993-6:2017

NBN EN ISO 10993-6:2017

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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)

€145.00

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ISO 13132:2023

ISO 13132:2023

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Laboratory glassware — Petri dishes

€77.00

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ISO 10993-1:2025

ISO 10993-1:2025

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Biological evaluation of medical devices

€204.00

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ISO 4307:2021

ISO 4307:2021

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for saliva — Isolated human DNA

€77.00

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ISO 20658:2023

ISO 20658:2023

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Requirements for the collection and transport of samples for medical laboratory examinations

€208.00

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ISO 6717:2021

ISO 6717:2021

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In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood

€115.00

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DIN EN ISO 10993-17/A1:2024-09

DIN EN ISO 10993-17/A1:2024-09

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Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents - Amendment 1 (ISO 10993-17:2023/DAM 1:2024); German and English version EN ISO 10993-17:2023/prA1:2024

€63.27

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