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DS/ISO/IEC Guide 63:2019

Guide to the development and inclusion of aspects of safety in international standards for medical devices


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 74.53

DS/EN 1041 + A1:2013

Information supplied by the manufacturer of medical devices


Status:
Current
Type:
Standard
Language:
Danish/English
Subject:
Price from:
€ 96.56
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/CEN/CR 13217:1998

Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.81

DS/EN ISO 13485:2016

Medical devices – Quality management systems – Requirements for regulatory purposes


Status:
Current
Type:
Standard
Language:
Danish/English - English
Subject:
Price from:
€ 140.34
Legislation:

DS/EN ISO 13485:2016/AC:2018

Medical devices – Quality management systems – Requirements for regulatory purposes


Status:
Current
Type:
Correction sheet
Language:
English
Subject:
Price from:
€ 0.00
Legislation:

DS/EN 13718-1:2014+A1:2020

Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 45.80
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/EN 13718-2:2015+A1:2020

Medical vehicles and their equipment – Air ambulances – Part 2: Operational and technical requirements for air ambulances


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.53
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/CEN/CLC/TR 14060:2015

Medical device traceability enabled by unique device identification (UDI)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 41.77

DS/EN ISO 14971:2019

Medical devices – Application of risk management to medical devices (ISO 14971:2019)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.56
Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


DS/ISO 14971:2019

Medical devices – Application of risk management to medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 85.95

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