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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:
€ 56.88

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:
€ 140.52

DS/EN ISO 13485:2016/A11:2021

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


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 61.05

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

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:
€ 45.85
Legislation:

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:
€ 74.63
Legislation:

DS/CEN/CLC/TR 14060:2015

Medical device traceability enabled by unique device identification (UDI)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 41.82

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:
€ 96.68
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/TR 15133:2005

Nomenclature – Collective terms and codes for groups of medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 45.85

DS/EN ISO 15223-1:2021

Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.75
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 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:
€ 133.79

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:
€ 123.71

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:
€ 41.82
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:
€ 113.89

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:
€ 96.68

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:
€ 113.89
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:
€ 123.71

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:
€ 104.75
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:
€ 183.55
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:
€ 136.48
Legislation:

DS/EN 60601-1/A12:2014

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


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN 60601-1:2006/A2:2021

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


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 104.75

DS/EN 60601-1/Corr. 2:2008

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


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

DS/EN 60601-1/Corr. 1:2008

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


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

DS/EN 60601-1/AC:2013

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


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

DS/EN 60601-1-2:2015

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 136.48
Legislation:

DS/EN 60601-1-2:2015/A1:2021

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 86.06

DS/EN 60601-1-6:2010

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 68.17
Legislation:

DS/EN 60601-1-6:2010/A1:2015

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN 60601-1-6:2010/A2:2021

Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 45.85

DS/EN 60601-1-8:2007

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 113.89
Legislation:

DS/EN 60601-1-8/A1:2013

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 74.63

DS/EN 60601-1-8:2007/A11:2017

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 34.56
Legislation:

DS/EN 60601-1-8:2007/A2:2021

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 104.75

DS/EN 60601-1-8/AC:2012

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


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

DS/EN 60601-1-8/A1/AC:2014

Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems


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

DS/EN 60601-1-9:2008

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 74.63

DS/EN 60601-1-9/A1:2013

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 34.56

DS/EN 60601-1-9:2008/A2:2020

Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN 60601-1-10:2008

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 86.06
Legislation:

DS/EN 60601-1-10:2008/A1:2015

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN 60601-1-10:2008/A2:2021

Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controllers


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 56.88

DS/EN 60601-1-11:2015

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 104.75
Legislation:

DS/EN 60601-1-11:2015/A1:2021

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 45.85

DS/EN 60601-1-12:2015

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 96.68

DS/EN 60601-1-12:2015/A1:2020

Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN 60601-2-16:1998

Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 56.88
Legislation:

DS/EN 60601-2-22:2013

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 74.63
Legislation:

DS/EN IEC 60601-2-22:2020

Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 86.06
Legislation:

DS/EN 60601-2-31:2008

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 86.06

DS/EN IEC 60601-2-31:2020

Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 104.75

DS/EN 60601-2-31/A1:2011

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source


Status:
Current
Type:
Addendum
Language:
English
Price from:
€ 41.82

DS/EN IEC 60601-2-35:2021

Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 113.89
Legislation:

DS/EN 60601-2-36:2015

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 61.05
Legislation:

DS/EN 60601-2-62:2015

Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 104.75

DS/EN IEC 60601-2-75:2019

Medical Electrical Equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 74.63

DS/IEC TR 60601-4-1:2017

Medical electrical equipment – Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 113.89

DS/IEC TR 60601-4-2:2016

Medical electrical equipment – Part 4-2: Guidance and interpretation – Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 104.75

DS/IEC TR 60601-4-3:2018

Medical electrical equipment – Part 4-3: Guidance and interpretation – Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 140.52

DS/IEC TR 60601-4-4:2017

Medical electrical equipment – Part 4-4: Guidance and interpretation – Guidance for writers of particular standards when creating alarm system-related requirements


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 61.05

DS/IEC TR 60601-4-5:2021

Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety-related technical security specifications


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 96.68

DS/EN 61205:2007

Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 56.88

DS/IEC/TR 61258:2008

Guidelines for the development and use of medical electrical equipment educational materials


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 45.85

DS/IEC TR 61289:2019

High frequency surgical equipment and high frequency surgical accessories – Operation and maintenance


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 74.63

DS/EN 61847:1999

Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics


Status:
Current
Type:
Standard
Language:
English/French
Price from:
€ 74.63

DS/EN 62304:2006

Medical device software - Software life-cycle processes


Status:
Current
Type:
Standard
Language:
English
Under revision:
Price from:
€ 113.89
Legislation:

DS/EN 62304:2006/A1:2015

Medical device software - Software life-cycle processes


Status:
Current
Type:
Addendum
Language:
English
Under revision:
Price from:
€ 96.68

DS/EN 62304/AC:2013

Medical device software - Software life-cycle processes


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