11.040.01 : Medical equipment in general

NF EN 868-10, S98-051-10 (12/2018)

NF EN 868-10, S98-051-10 (12/2018)

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Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods

€65.33

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NF EN 868-8, S98-051-8 (12/2018)

NF EN 868-8, S98-051-8 (12/2018)

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Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods - Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 8 : Conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d?essai

€82.00

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DIN EN ISO 20417:2019-04

DIN EN ISO 20417:2019-04

Superseded Historical

Medical Devices - Information to be provided by the manufacturer (ISO/DIS 20417:2019); German and English version prEN ISO 20417:2019

€179.53

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DIN EN ISO 14971:2020-07

DIN EN ISO 14971:2020-07

Superseded Historical

Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019

€134.02

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DIN EN 13718-1:2020-10

DIN EN 13718-1:2020-10

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Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German version EN 13718-1:2014+A1:2020

€77.20

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DIN EN 13718-2:2020-10

DIN EN 13718-2:2020-10

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Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German version EN 13718-2:2015+A1:2020

€116.64

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DIN SPEC 91422:2020-06

DIN SPEC 91422:2020-06

Superseded Historical

Requirements for planning and safety in the multifunctional high-tech working environment surgical theatre

€0.00

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DIN EN ISO 15223-1/A1:2019-11

DIN EN ISO 15223-1/A1:2019-11

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Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019

€77.20

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DIN EN ISO 13485/A1:2019-11

DIN EN ISO 13485/A1:2019-11

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019

€134.02

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DIN EN ISO 15223-1:2020-04

DIN EN ISO 15223-1:2020-04

Superseded Historical

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020

€122.34

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UNE-EN ISO 10993-16:2018

UNE-EN ISO 10993-16:2018

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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

€73.00

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UNE-EN ISO 13485:2018

UNE-EN ISO 13485:2018

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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)

€123.00

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UNE-EN ISO 15378:2018

UNE-EN ISO 15378:2018

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Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)

€134.00

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UNE-EN ISO 15223-1:2017

UNE-EN ISO 15223-1:2017

Superseded Historical

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

€91.00

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UNE-EN 62304:2007

UNE-EN 62304:2007

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Medical device software - Software life-cycle processes (IEC 62304:2006)

€129.00

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