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)
Abstract
ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.
ISO 11137-1:2006 does not:
- specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
- detail specified requirements for designating a medical device as sterile;
- specify a quality management system for the control of all stages of production of medical devices;
- specify requirements for occupational safety associated with the design and operation of irradiation facilities;
- specify requirements for the sterilization of used or reprocessed devices.
DIN EN ISO 11137-1:2013-12 (E)
Ster ilization 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) (includes Amendment A1:2013)
Contents Page
Introduction …………………………………………………………………………………………………………………………………… 5
1 Scope …………………………………………………………………………………………………………………………….. 7
2 Normative references ……………………………………………………………………………………………………… 8
3 Terms and definitions …………………………………………………………………………………………………….. 8
4 Quality management system elements ………………………………………………………………………….. 14
4.1 Documentation …………………………………………………………………………………………………………….. 14
4.2 Management responsibility …………………………………………………………………………………………… 15
4.3 Product realization ……………………………………………………………………………………………………….. 15
4.4 Measurement, analysis and improvement — Control of nonconforming product …………….. 15
5 Sterilizing agent characterization ………………………………………………………………………………….. 15
5.1 Sterilizing agent ……………………………………………………………………………………………………………. 15
5.2 Microbicidal effectiveness ……………………………………………………………………………………………. 15
5.3 Material effects …………………………………………………………………………………………………………….. 15
5.4 Environmental considerations ………………………………………………………………………………………. 16
6 Process and equipment characterization ………………………………………………………………………. 16
6.1 Process ……………………………………………………………………………………………………………………….. 16
6.2 Equipment ……………………………………………………………………………………………………………………. 16
7 Product definition …………………………………………………………………………………………………………. 17
8 Process definition ………………………………………………………………………………………………………… 18
8.1 Establishing the maximum acceptable dose …………………………………………………………………. 18
8.2 Establishing the sterilization dose ………………………………………………………………………………… 18
8.3 Specifying the maximum acceptable dose and the sterilization dose …………………………….. 19
8.4 Transference of maximum acceptable, verification or sterilization dose between
radiation sources …………………………………………………………………………………………………………. 19
9 Validation …………………………………………………………………………………………………………………….. 20
9.1 Installation qualification ……………………………………………………………………………………………….. 20
9.2 Operational qualification ………………………………………………………………………………………………. 20
9.3 Performance qualification …………………………………………………………………………………………….. 21
9.4 Review and approval of validation ………………………………………………………………………………… 21
10 Routine monitoring and control ……………………………………………………………………………………. 22
11 Product release from sterilization …………………………………………………………………………………. 23
12 Maintaining process effectiveness ………………………………………………………………………………… 23
12.1 Demonstration of continued effectiveness ……………………………………………………………………. 23
12.2 Recalibration ………………………………………………………………………………………………………………… 26
12.3 Maintenance of equipment ……………………………………………………………………………………………. 26
12.4 Requalification of equipment ………………………………………………………………………………………… 26
12.5 Assessment of change …………………………………………………………………………………………………. 26
Annex A (informative) Guidance ………………………………………………………………………………………………….. 27
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………… 42
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ……………………………………….. 43
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices …………….. 44
Bibliography ……………………………………………………………………………………………………………………………….. 45