11.040.01 : Medical equipment in general

UNE-EN ISO 13485:2012

UNE-EN ISO 13485:2012

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)

€129.00

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UNE-EN ISO 15223-1:2013

UNE-EN ISO 15223-1:2013

Superseded Historical

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

€77.00

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UNE-EN ISO 13485:2013

UNE-EN ISO 13485:2013

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (ISO 13485:2003+Cor 1:2009)

€129.00

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UNE-EN 60601-1:2008/AC:2014

UNE-EN 60601-1:2008/AC:2014

Withdrawn Most Recent

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

€0.00

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UNE-EN 62366:2009/A1:2015

UNE-EN 62366:2009/A1:2015

Superseded Historical

Medical devices - Application of usability engineering to medical devices

€53.00

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UNE-EN ISO 15378:2016

UNE-EN ISO 15378:2016

Superseded Historical

Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

€125.00

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UNE-EN ISO 13485:2016

UNE-EN ISO 13485:2016

Superseded Historical

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

€115.00

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UNE-EN ISO 15225:2016

UNE-EN ISO 15225:2016

Withdrawn Most Recent

Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)

€69.00

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UNE-EN ISO 13485:2016/AC:2017

UNE-EN ISO 13485:2016/AC:2017

Superseded Historical

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

€0.00

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DIN EN 540:1993-07

DIN EN 540:1993-07

Superseded Historical

Clinical investigation of medical devices for human subjects; German version EN 540:1993

€63.27

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DIN V 40102-1:1993-09

DIN V 40102-1:1993-09

Superseded Historical

Graphical symbols for use on medical-technical equipment; survey

€185.05

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DIN 58356-2:1993-11

DIN 58356-2:1993-11

Superseded Historical

Membrane filter elements; pressure hold test

€41.78

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DIN 58356-3:1993-11

DIN 58356-3:1993-11

Superseded Historical

Membrane filter elements; specific liquid flow rate; testing

€41.78

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DIN EN 46001:1993-12

DIN EN 46001:1993-12

Superseded Historical

Quality systems; medical devices; particular requirements for the application of EN 29001; German version EN 46001:1993

€56.17

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DIN EN 46002:1993-12

DIN EN 46002:1993-12

Superseded Historical

Quality systems; medical devices; particular requirements for the application of EN 29002; German version EN 46002:1993

€56.17

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