11.040.01 : Medical equipment in general

DIN EN ISO 14971:2009-10

DIN EN ISO 14971:2009-10

Superseded Historical

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2009.

€195.79

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DIN EN ISO 13485 Berichtigung 1:2017-07

DIN EN ISO 13485 Berichtigung 1:2017-07

Superseded Historical

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016

€0.00

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DIN EN ISO 15378:2018-04

DIN EN ISO 15378:2018-04

Active Most Recent

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); German version EN ISO 15378:2017

€195.79

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DIN EN 13718-1/A1:2018-04

DIN EN 13718-1/A1:2018-04

Superseded Historical

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances; German and English version EN 13718-1:2014/prA1:2018

€56.17

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DIN EN 13718-2/A1:2018-04

DIN EN 13718-2/A1:2018-04

Superseded Historical

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances; German and English version EN 13718-2:2015/prA1:2018

€63.27

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DIN EN ISO 14971:2018-08

DIN EN ISO 14971:2018-08

Superseded Historical

Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018

€150.65

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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Superseded Historical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Superseded Historical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 ISO 15223-1/A1:2019-11

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

Withdrawn Most Recent

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 1041:1998-04

DIN EN 1041:1998-04

Superseded Historical

Information supplied by the manufacturer with medical devices; German version EN 1041:1998

€84.58

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DIN EN ISO 10993-14:2002-05

DIN EN ISO 10993-14:2002-05

Superseded Historical

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001); German version EN ISO 10993-14:2001.

€84.58

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DIN EN 13718-1:2002-11

DIN EN 13718-1:2002-11

Superseded Historical

Air, water and difficult terrain ambulances - Part 1: Medical device interface requirements for the continuity of patient care; German version EN 13718-1:2002

€91.03

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DIN EN 13718-2:2002-11

DIN EN 13718-2:2002-11

Superseded Historical

Air, water and difficult terrain ambulances - Part 2: Operational and technical requirements for the continuity of patient care; German version EN 13718-2:2002

€98.32

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BS EN ISO 389-8:2004

BS EN ISO 389-8:2004

Active Most Recent

Acoustics. Reference zero for the calibration of audiometric equipment equivalent threshold sound pressure levels pure tones and circumaural earphones

€201.00

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