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 13612/AC:2003 (R2014)

UNE-EN 13612/AC:2003 (R2014)

Active Most Recent

Performance evaluation of in vitro diagnostic medical devices.

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UNE-EN 13975:2003 (R2020)

UNE-EN 13975:2003 (R2020)

Active Most Recent

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects

€60.00

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UNE 129001:1997

UNE 129001:1997

Active Most Recent

CLINICAL LABORATORY REPORTS. PREPARING REQUIREMENTS.

€50.00

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ISO 12771:1997 (R2024)

ISO 12771:1997 (R2024)

Active Most Recent

Plastics laboratory ware — Disposable serological pipettes

€51.00

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ISO 12772:1997 (R2018)

ISO 12772:1997 (R2018)

Active Most Recent

Laboratory glassware — Disposable microhaematocrit capillary tubes

€77.00

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ISO 18153:2003 (R2019)

ISO 18153:2003 (R2019)

Withdrawn Most Recent

In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials

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ISO 15198:2004 (R2018)

ISO 15198:2004 (R2018)

Withdrawn Most Recent

Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer

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ISO 14155:2011

ISO 14155:2011

Superseded Historical

Clinical investigation of medical devices for human subjects — Good clinical practice

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ISO 13022:2012 (R2022)

ISO 13022:2012 (R2022)

Active Most Recent

Medical products containing viable human cells — Application of risk management and requirements for processing practices

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ISO 13132:2011 (R2017)

ISO 13132:2011 (R2017)

Superseded Historical

Laboratory glassware — Petri dishes

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ISO 15189:2012

ISO 15189:2012

Superseded Historical

Medical laboratories — Requirements for quality and competence

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PR NF EN ISO 10993-7, S99-501-7PR (07/2024)

PR NF EN ISO 10993-7, S99-501-7PR (07/2024)

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Évaluation biologique des dispositifs médicaux - Partie 7 : Résidus de stérilisation à l'oxyde d'éthylène

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NF EN ISO 10993-12/A1, S99-501-12/A1 (09/2025)

NF EN ISO 10993-12/A1, S99-501-12/A1 (09/2025)

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Évaluation biologique des dispositifs médicaux - Partie 12 : Préparation des échantillons et matériaux de référence - Amendement 1

€52.00

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DIN EN 14136:2004-08

DIN EN 14136:2004-08

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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures; German version EN 14136:2004

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DIN EN 14254:2004-09

DIN EN 14254:2004-09

Superseded Historical

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans; German version EN 14254:2004

€84.58

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