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
ASTM F624-09(2024)

ASTM F624-09(2024)

Superseded Historical

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

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ASTM F2382-17e1

ASTM F2382-17e1

Superseded Historical

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

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ASTM E788-97(2024)

ASTM E788-97(2024)

Active Most Recent

Standard Specification for Pipet, Blood Diluting

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ASTM E923-97(2024)

ASTM E923-97(2024)

Active Most Recent

Standard Specification for Glass Westergren Tube, Reusable

€58.00

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BS EN 375:1992

BS EN 375:1992

Superseded Historical

Specification for labelling of in vitro diagnostic reagents for professional use

€165.00

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BS EN 376:1992

BS EN 376:1992

Superseded Historical

Specification for labelling of in vitro diagnostic reagents for self-testing

€165.00

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BS EN ISO 15197:2013

BS EN ISO 15197:2013

Withdrawn Most Recent

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus

€374.00

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BS EN ISO 14155-1:2009

BS EN ISO 14155-1:2009

Superseded Historical

Clinical investigation of medical devices for human subjects General requirements

€269.00

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BS EN ISO 14155-2:2009

BS EN ISO 14155-2:2009

Superseded Historical

Clinical investigation of medical devices for human subjects plans

€193.00

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BS EN ISO 23640:2011

BS EN ISO 23640:2011

Superseded Historical

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

€193.00

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BS EN ISO 10993-9:May 2009

BS EN ISO 10993-9:May 2009

Superseded Historical

Framework for identification and quantification of potential degradation products

€193.00

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BS EN ISO 7405:2008+A1:2013

BS EN ISO 7405:2008+A1:2013

Superseded Historical

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

€316.00

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BS EN ISO 10993-10:2010

BS EN ISO 10993-10:2010

Superseded Historical

Biological evaluation of medical devices Tests for irritation and skin sensitization

€404.00

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BS EN ISO 15189:2012

BS EN ISO 15189:2012

Withdrawn Most Recent

Medical laboratories. Requirements for quality and competence

€374.00

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BS EN ISO 10993-16:2010

BS EN ISO 10993-16:2010

Superseded Historical

Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables

€193.00

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