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)
This part of ISO 11137 specifies requirements for the development, validation and control of the use of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may apply to other products and equipment. Radiation sterilization processes covered by this part of ISO 11137 use irradiation systems a) that use the radionuclides 60Co and 137Cs, b) in which accelerated electrons are generated, or c) in which X-rays are used by accelerated electrons. This part of ISO 11137 does not specify requirements for the development, validation and control of the use of a method for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. In certain countries, specific recommendations have been developed for the treatment of materials potentially contaminated with these pathogens. NOTE See for example ISO 22442-1, ISO 22442-2 and ISO 22442-3. This part of ISO 11137 does not specify a detailed requirement for marking a medical device as sterile. NOTE National or regional requirements for labeling medical devices as “sterile” should be observed. See for example EN 556-1 or ANSI/AAMI ST67. This part of ISO 11137 does not specify a quality management system to govern the application of all stages of medical device manufacturing. NOTE It is not a requirement of this part of ISO 11137 that a complete quality management system be in place during manufacturing, but the minimum required elements of a quality management system to guide the application of the sterilization process are provided as normative references at appropriate points in the text (see in particular Section 4). Please note the standards on quality management systems (see ISO 13485), which govern all stages of the production or processing of medical devices, including the sterilization process. Regional and national regulations for the supply of medical devices could require the enforcement of a complete quality management system and the assessment of this system by a third party. This part of ISO 11137 does not require the use of biological indicators to validate or guide radiation sterilization or that pharmacopoeial sterility testing be performed for product release. This part of ISO 11137 does not specify occupational health and safety requirements associated with the design and operation of irradiation facilities.
EN ISO 11137-1:2015 Referenced Document
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
ISO 10012-1:1992 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
ISO 9001:2008 Quality management systems - Requirements
ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
EN ISO 11137-1:2015 history
2019EN 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)
2015EN 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)
2013EN ISO 11137-1:2006/A1:2013 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/Amd 1:2013)
2006EN 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 ISO 11137-1:2006;:1994 [Superseded: CEN EN 552]