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DS/EN ISO 15223-1 Bil. 1:2021

Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements – Fact Sheet 1: Graphical symbols in electronic format


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 133.76

DS/EN ISO 15378:2017

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)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 123.67

DS/EN 15986:2011

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 41.81
Legislation:

DS/CEN/TR 17223:2018

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices – Quality management systems – Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.86

DS/CEN ISO/TR 20416:2020

Medical devices – Post-market surveillance for manufacturers (ISO/TR 20416:2020)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.65

DS/EN ISO 20417:2021

Medical devices – Information to be supplied by the manufacturer (ISO 20417:2021)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 113.86
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 ISO/TR 24971:2020

Medical devices – Guidance on the application of ISO 14971 (ISO/TR 24971:2020)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 123.67

DS/EN 45502-1:2015

Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 104.72
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 60601-1:2006

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


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 183.49
Legislation:

DS/EN 60601-1/A1:2013

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


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 136.44
Legislation: