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 10993-17:2003-06

DIN EN ISO 10993-17:2003-06

Superseded Historical

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2002.

€105.42

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DIN EN 13975:2003-11

DIN EN 13975:2003-11

Active Most Recent

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts

€84.58

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DIN EN ISO 14155-2:2003-09

DIN EN ISO 14155-2:2003-09

Superseded Historical

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003); German version EN ISO 14155-2:2003.

€69.91

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DIN EN ISO 17511:2003-11

DIN EN ISO 17511:2003-11

Superseded Historical

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003); German version EN ISO 17511:2003

€105.42

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DIN EN ISO 18153:2003-11

DIN EN ISO 18153:2003-11

Active Most Recent

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003

€77.20

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DIN EN ISO 14155-1:2003-09

DIN EN ISO 14155-1:2003-09

Superseded Historical

Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003); German version EN ISO 14155-1:2003.

€98.32

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DIN 58932-4:2003-07

DIN 58932-4:2003-07

Active Most Recent

Haematology - Determination of the concentration of blood corpuscles in blood - Part 4: Reference procedure for the determination of the concentration of leucocytes

€91.03

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DIN EN ISO 15195:2004-01

DIN EN ISO 15195:2004-01

Superseded Historical

Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003); German version EN ISO 15195:2003

€91.03

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ISO/TS 22583:2024

ISO/TS 22583:2024

Active Most Recent

Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment

€183.00

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UNE-EN ISO 10993-6:2007

UNE-EN ISO 10993-6:2007

Superseded Historical

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

€75.00

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UNE-ISO/TR 22869:2007 IN

UNE-ISO/TR 22869:2007 IN

Withdrawn Most Recent

Medical laboratories. Guidance on laboratory implementation of ISO 15189: 2003. (ISO/TR 22869:2005)

€71.00

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UNE-EN ISO 10993-12:2008

UNE-EN ISO 10993-12:2008

Superseded Historical

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

€72.00

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UNE-EN ISO 10993-12:2009

UNE-EN ISO 10993-12:2009

Superseded Historical

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007)

€73.00

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UNE-EN ISO 10993-13:2009

UNE-EN ISO 10993-13:2009

Superseded Historical

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998)

€69.00

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UNE-EN ISO 10993-3:2009

UNE-EN ISO 10993-3:2009

Superseded Historical

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)

€72.00

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