Standards in this category are focused on radiation sterilization with medical devices. There are several series of standards for radiation as well as others that focus on guidance measures.
1.1 This document specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope is limited to medical devices, this document can be applicable to other products and equipment. This document covers radiation processes employing irradiators using: a) the radionuclide 60 Co or 137 Cs; b) a beam from an electron generator; or c) a beam from an X-ray generator. 1.2 This document is not applicable to processes for inactivating viruses or the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE For information on such processes, see ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO 13022 and ICH Q5A. 1.2.1 This document does not specify requirements for designating a medical device as sterile. NOTE Regional and national requirements can designate medical devices as sterile. See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.2 This document does not specify a quality management system for the control of all stages of production of medical devices. NOTE It is not a requirement of this document to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, REF Section_sec_4 \r \h Clause 4 08D0C9EA79F9BACE118C8200AA004BA90B02000000080000000E000000530065006300740069006F006E005F007300650063005F0034000000 ). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices can require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.3 This document does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release. 1.2.4 This document does not specify requirements for occupational safety associated with the design and operation of irradiation facilities. NOTE Regulations on safety requirements for occupational safety related to radiation can exist in some countries. 1.2.5 This document does not specify requirements for the sterilization of used or reprocessed devices.
ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.
ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.
This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10 6 or less for radiation sterilization of health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. NOTE 1 Selection and substantiation of the sterilization dose is used to meet the requirements for establishing the sterilization dose within process definition in ISO 11137 1. This document does not apply to other sterilization doses than the substantiation of a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy. The method is not used for the substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3). NOTE 2 The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this document. They are described in ISO 11137 2. If the decision is made to use this method of sterilization dose establishment, the method is intended to be followed in accordance with the requirements (shall) and guidance (should) stipulated herein.
This technical information report describes approaches to the selection and auditing of a sterilization dose that may reduce the number of product items required while maintaining assurance of attaining the desired sterility assurance level (SAL). This approach addresses sampling plans for verification dose experiments and sterilization dose audits. In addition the approaches to adopting a product into an established product family are defined.
This technical information report (TIR) provides guidance for development, validation and routine control associated with the radiation sterilization processing of biologics and tissue-based products
This technical information report describes the approach for establishing a sterilization dose utilizing a modification of the fraction positive, incremental dosing method defined in Method 2 of ANSI/AAMI/ISO 11137-2.
This technical information report identifies the necessary steps to effectively manage medical devices not owned by the health care facility in which they are used. This TIR addresses the management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection by the receiving facility prior to patient use. This document includes processes for the request, receipt, return, and documentation of loaned medical devices. Included are the roles and responsibilities of the health care facility ("receiver"), the lending entity ("sender"), and individuals