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
UNE-EN ISO 14155-2:2009

UNE-EN ISO 14155-2:2009

Superseded Historical

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)

€62.00

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UNE-EN ISO 18113-2:2010

UNE-EN ISO 18113-2:2010

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

€69.00

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UNE-EN ISO 18113-1:2010

UNE-EN ISO 18113-1:2010

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

€100.00

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UNE-EN ISO 10993-16:2010

UNE-EN ISO 10993-16:2010

Superseded Historical

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

€69.00

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UNE-EN ISO 18113-4:2010

UNE-EN ISO 18113-4:2010

Superseded Historical

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)

€64.00

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UNE-EN ISO 14155:2011

UNE-EN ISO 14155:2011

Superseded Historical

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

€114.00

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UNE-EN ISO 15197:2013

UNE-EN ISO 15197:2013

Superseded Historical

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)

€103.00

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UNE-EN ISO 7405:2009/A1:2014

UNE-EN ISO 7405:2009/A1:2014

Superseded Historical

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry - Amendment 1: Positive control material (ISO 7405:2008/Amd 1:2013)

€28.00

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ASTM E1811-96(2001)

ASTM E1811-96(2001)

Superseded Historical

Standard Test Method for Oncogenicity Study in Rats and Mice

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ASTM D7225-13(2019)e1

ASTM D7225-13(2019)e1

Superseded Historical

Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors

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ASTM E923-97(2019)

ASTM E923-97(2019)

Superseded Historical

Standard Specification for Glass Westergren Tube, Reusable

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ASTM E788-97(2019)

ASTM E788-97(2019)

Superseded Historical

Standard Specification for Pipet, Blood Diluting

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ASTM E714-94(1998)

ASTM E714-94(1998)

Superseded Historical

Standard Specification for Disposable Glass Serological Pipets

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ASTM E732-80(2001)e1 (R1980)

ASTM E732-80(2001)e1 (R1980)

Superseded Historical

Standard Specification for Disposable Pasteur-Type Pipet

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ASTM E734-80(1999)e1

ASTM E734-80(1999)e1

Superseded Historical

Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)

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