ISO 25424:2009
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
01-05-2019
Superseded by
Language(s)
English, French
Published date
14-08-2009
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 25424:2009 specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
ISO 25424:2009 is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices.
ISO 25424:2009 covers sterilization processes that use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
| DevelopmentNote |
Supersedes ISO/DIS 25424. (08/2009)
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| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
International Organization for Standardization
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| ONORM EN ISO 25424 : 2011 | Identical |
| NF EN ISO 25424 : 2011 | Identical |
| NBN EN ISO 25424 : 2011 | Identical |
| NEN ISO 25424 : 2009 | Identical |
| NEN EN ISO 25424 : 2011 | Identical |
| NS EN ISO 25424 : 2011 | Identical |
| I.S. EN ISO 25424:2011 | Identical |
| PN EN ISO 25424 : 2013 | Identical |
| SN EN ISO 25424 : 2011 | Identical |
| UNI EN ISO 25424 : 2011 | Identical |
| UNE-EN ISO 25424:2011 | Identical |
| BS EN ISO 25424:2011 | Identical |
| EN ISO 25424:2011 | Identical |
| DIN EN ISO 25424:2011-09 | Identical |
| GOST R ISO 25424 : 2013 | Identical |
| ANSI/AAMI/ISO 11138-5:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES |
| 16/30346073 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| BS EN ISO 11138-5:2017 | Sterilization of health care products. Biological indicators Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| EN 12182:2012 | Assistive products for persons with disability - General requirements and test methods |
| 15/30328959 DC : 0 | BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 14/30266295 DC : 0 | BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BS 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/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 |
| DIN EN 556-2:2015-11 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| DIN EN 12182:2012-07 | Assistive products for persons with disability - General requirements and test methods |
| BS EN 556-2:2015 | Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices |
| I.S. EN 12182:2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| I.S. EN ISO 11138-5:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017) |
| DIN EN 14180:2003-10 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| I.S. EN 14180:2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| PREN 556-2 : DRAFT 2014 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 14/30290166 DC : 0 | BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| 12/30254927 DC : 0 | BS EN 16372 - AESTHETIC SURGERY SERVICES |
| ISO 18362:2016 | Manufacture of cell-based health care products Control of microbial risks during processing |
| ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. 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) |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| UNI EN 14180 : 2014 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| UNI EN 12182 : 2012 | ASSISTIVE PRODUCTS FOR PERSONS WITH DISABILITY - GENERAL REQUIREMENTS AND TEST METHODS |
| PREN 17180 : DRAFT 2017 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE VAPORIZED HYDROGEN PEROXIDE STERILIZERS - REQUIREMENTS AND TESTING |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| BS ISO 18362:2016 | Manufacture of cell-based health care products. Control of microbial risks during processing |
| I.S. EN 556-2:2015 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| 16/30280931 DC : DRAFT APR 2016 | BS EN ISO 17664 - PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| PD 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 |
| DIN EN 14180:2014-09 | STERILIZERS FOR MEDICAL PURPOSES - LOW TEMPERATURE STEAM AND FORMALDEHYDE STERILIZERS - REQUIREMENTS AND TESTING |
| UNE-EN 556-2:2016 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| BS EN 14180:2014 | Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing |
| BS EN 12182:2012 | Assistive products for persons with disability. General requirements and test methods |
| EN ISO 11138-5:2017 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
| EN 16372:2014 | Aesthetic surgery services |
| EN 556-2:2015 | Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| BS EN 16372:2014 | Aesthetic surgery services |
| 14/30273161 DC : 0 | BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| 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) |
| DIN EN ISO 11138-5:2015-10 (Draft) | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017) |
| UNE-EN ISO 11138-5:2017 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
| CAN/CSA-ISO 11138-5:17 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (Adopted ISO 11138-5:2017, second edition, 2017-03) |
| EN ISO 11737-2:2009 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
| IEC 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| 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 (ISO 14937:2009) |
| EN 61010-2-040:2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
| ISO 11737-2:2009 | Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 |
| EN ISO 14161:2009 | Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009) |
| 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 |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| EN ISO 11138-1:2017 | Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017) |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| AAMI RD47 : 2008 | REPROCESSING OF HEMODIALYZERS |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| CEN Guide 4:2008 | GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS |
| EN ISO 10012:2003 | Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003) |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN ISO 11138-5:2017 | Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017) |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| 1997/23/EC : 1997 | DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT |
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