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
DIN EN ISO 10993-23:2019-08

DIN EN ISO 10993-23:2019-08

Superseded Historical

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO/DIS 10993-23:2019); German and English version prEN ISO 10993-23:2019

€179.53

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DIN EN ISO 10993-23:2021-10

DIN EN ISO 10993-23:2021-10

Superseded Historical

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

€185.05

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DIN EN ISO 10993-1:2024-07

DIN EN ISO 10993-1:2024-07

Superseded Historical

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO/DIS 10993-1:2024); German and English version prEN ISO 10993-1:2024

€150.65

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ISO/TS 10993-20:2006 (R2021)

ISO/TS 10993-20:2006 (R2021)

Active Most Recent

Biological evaluation of medical devices Part 20: Principles and methods for immunotoxicology testing of medical devices

€115.00

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ISO/TR 22442-4:2010 (R2016)

ISO/TR 22442-4:2010 (R2016)

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Medical devices utilizing animal tissues and their derivatives Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

€115.00

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ISO 21474-1:2020 (R2026)

ISO 21474-1:2020 (R2026)

Active Most Recent

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 1: Terminology and general requirements for nucleic acid quality evaluation

€155.00

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ISO/TR 10993-55:2023

ISO/TR 10993-55:2023

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Biological evaluation of medical devices Part 55: Interlaboratory study on cytotoxicity

€155.00

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ISO/TS 7552-1:2024

ISO/TS 7552-1:2024

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 1: Isolated RNA

€155.00

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ISO/TS 7552-2:2024

ISO/TS 7552-2:2024

Active Most Recent

Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 2: Isolated DNA

€155.00

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ISO/TS 7552-3:2024

ISO/TS 7552-3:2024

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Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood Part 3: Preparations for analytical CTC staining

€115.00

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ISO 21474-3:2024

ISO 21474-3:2024

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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids Part 3: Interpretation and reports

€115.00

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ISO 18704:2026

ISO 18704:2026

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Molecular in vitro diagnostic examinations — Requirements and recommendations for pre-examination processes for urine and other body fluids — Isolated cell-free DNA

€155.00

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ISO 10993-23:2021/Amd 1:2025

ISO 10993-23:2021/Amd 1:2025

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Biological evaluation of medical devices — Part 23: Tests for irritation Amendment 1: Additional in vitro reconstructed human epidermis models

€21.00

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ISO 10993-4:2017 (R2023)

ISO 10993-4:2017 (R2023)

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Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood

€235.00

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ISO 10993-9:2019

ISO 10993-9:2019

Active Most Recent

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

€115.00

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