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DS/EN 556-1:2001

Sterilization of medical devices - Requirements for medical devices to be designated "Sterile" - Part 1: Requirements for terminally sterilized medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.51
Legislation:

DS/EN 556-1/AC:2006

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices


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

DS/EN 556-2:2015

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices


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

DS/EN 867-5:2001

Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 60.97

DS/EN 1499:2013

Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements (phase 2/step 2)


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

DS/EN 1500:2013

Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements (phase 2/step 2)


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

DS/EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.75
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 11135:2014/A1:2019

Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices – Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 60.97

DS/EN ISO 11137-1:2015

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.75
Legislation:

DS/EN ISO 11137-1:2015/A2:2019

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices – Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)


Status:
Current
Type:
Addendum
Language:
English
Subject:
Price from:
€ 60.97
Legislation:

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