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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:
€ 34.56
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:
€ 45.86
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:
€ 61.05

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:
€ 74.64

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:
€ 86.07

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:
€ 113.91
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:
€ 61.05

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:
€ 113.91
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:
€ 61.05
Legislation:

DS/EN ISO 11137-2:2015

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 123.72
Legislation:

DS/EN ISO 11137-3:2017

Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69

DS/ISO/TS 11137-4:2020

Sterilization of health care products – Radiation – Part 4: Guidance on process control


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/EN ISO 11138-7:2019

Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/ISO 11138-7:2019

Sterilization of health care products – Biological indicators – Part 7: Guidance for the selection, use and interpretation of results


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/EN ISO 11139:2018

Sterilization of health care products – Vocabulary – Terms used in sterilization and related equipment and process standards (ISO 11139:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/EN ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07
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 11140-3:2009

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64
Legislation:

DS/EN ISO 11140-4:2007

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07

DS/ISO 11140-5:2007

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.89

DS/EN ISO 11737-1:2018

Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76
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 11737-2:2020

Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07
Legislation:

DS/ISO 11737-2:2019

Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process


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

DS/EN 12347:1998

Biotechnology - Performance criteria for steam sterilizers and autoclaves


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

DS/CEN ISO/TS 13004:2014

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 113.91

DS/EN ISO 13408-1:2015

Aseptic processing of health care products - Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76
Legislation:

DS/EN ISO 13408-2:2018

Aseptic processing of health care products – Part 2: Sterilizing filtration (ISO 13408-2:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

DS/EN ISO 13408-3:2011

Aseptic processing of health care products - Part 3: Lyophilization


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

DS/EN ISO 13408-4:2011

Aseptic processing of health care products - Part 4: Clean-in-place technologies


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

DS/EN ISO 13408-5:2011

Aseptic processing of health care products - Part 5: Sterilization in place


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 68.18
Legislation:

DS/EN ISO 13408-6:2011

Aseptic processing of health care products - Part 6: Isolator systems


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 74.64
Legislation:

DS/EN ISO 13408-6/A1:2013

Aseptic processing of health care products - Part 6: Isolator systems


Status:
Current
Type:
Addendum
Language:
English
Subject:
Under revision:
Price from:
€ 45.86

DS/EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64
Legislation:

DS/EN ISO 14160:2011

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
Price from:
€ 96.69

DS/EN ISO 14937:2009

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

DS/EN ISO 15882:2008

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07

DS/EN ISO 17664:2017

Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)


Status:
Current
Type:
Standard
Language:
Danish/English - English
Subject:
Price from:
€ 74.64
Legislation:

DS/ISO 17664-2:2021

Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64

DS/EN ISO 17665-1:2006

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69
Legislation:

DS/CEN ISO/TS 17665-2:2009

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/ISO/TS 17665-3:2014

Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/ISO 18362:2016

Manufacture of cell-based health care products -- Control of microbial risks during processing


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07

DS/EN ISO 18472:2018

Sterilization of health care products – Biological and chemical indicators – Test equipment (ISO 18472:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.07

DS/ISO/TS 19930:2017

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 74.64

DS/EN ISO 20857:2013

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76

DS/ISO/TS 21387:2020

Sterilization of medical devices – Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release


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

DS/ISO/TS 22421:2021

Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69

DS/ISO/TS 22456:2021

Sterilization of healthcare products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 56.89

DS/EN ISO 25424:2019

Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 104.76
Legislation:

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:
€ 161.52

ISO 11135:2014/Amd 1:2018

Revision of Annex E, Single batch release


Status:
Current
Type:
Addendum
Language:
English
Subject:

ISO 11137-1:2006

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 143.38

ISO 11137-1:2006/Amd 2:2018

Revision to 4.3.4 and 11.2


Status:
Current
Type:
Addendum
Language:
English
Subject:

ISO 11138-1:2017

Sterilization of health care products -- Biological indicators -- Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 143.38

ISO 11138-2:2017

Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 34.48

ISO 11138-7:2019

Sterilization of health care products -- Biological indicators -- Part 7: Guidance for the selection, use and interpretation of results


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 11139:2018

Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 11140-1:2014

Sterilization of health care products -- Chemical indicators -- Part 1: General requirements


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 125.23

ISO 11140-3:2007

Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 107.08

ISO 11140-4:2007

Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 125.23

ISO 11737-2:2019

Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 13408-3:2006

Aseptic processing of health care products -- Part 3: Lyophilization


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 52.63

ISO 13408-5:2006

Aseptic processing of health care products -- Part 5: Sterilization in place


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 79.85

ISO 13408-6:2021

Aseptic processing of health care products – Part 6: Isolator systems


Status:
Current
Type:
Standard
Language:
English
Subject:

ISO 14160:2020

Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 143.38

ISO 14937:2009

Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 143.38

ISO 17664:2017

Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 107.08

ISO 20857:2010

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 161.52

ASTM E1327 - 07(2018)

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 41.22

ASTM E1173 - 15

Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 41.22

ASTM E1838 - 17

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 41.22

ASTM E1837 - 96(2014)

Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)


Status:
Current
Type:
Standard
Language:
English
Price from:
€ 41.22