Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
Abstract
ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.
Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
DIN EN ISO 11135-1:2007-08 (E)
Sterilization of health care products – E thylene oxide – Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical
devices (ISO 11135-1:2007)
Contents Page
Foreword…………………………………………………………………………………………………………………………………………..3
Introduction ………………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………………6
2
3 Terms and definitions ……………………………………………………………………………………………………………7
4 Quality management systems…………………………………………………………………………………………….. 14
4.1 Documentation…………………………………………………………………………………………………………………… 14
4.2 Management responsibility ………………………………………………………………………………………………… 14
4.3 Product realization……………………………………………………………………………………………………………… 14
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 ……………………………………………………………………………………………. 15
6 Process and equipment characterization ……………………………………………………………………………. 15
6.1 Process characterization ……………………………………………………………………………………………………. 15
6.2 Equipment characterization………………………………………………………………………………………………… 16
7 Product definition ………………………………………………………………………………………………………………. 17
7.1 General………………………………………………………………………………………………………………………………. 17
7.2 Product safety and performance…………………………………………………………………………………………. 17
7.3 Microbiological quality……………………………………………………………………………………………………….. 17
7.4 Documentation…………………………………………………………………………………………………………………… 18
8 Process definition………………………………………………………………………………………………………………. 18
9 Validation…………………………………………………………………………………………………………………………… 19
9.1 Installation qualification……………………………………………………………………………………………………… 19
9.2 Operational qualification…………………………………………………………………………………………………….. 19
9.3 Performance qualification…………………………………………………………………………………………………… 19
9.4 Varying load configurations ……………………………………………………………………………………………….. 21
9.5 Review and approval of validation………………………………………………………………………………………. 21
10 Routine monitoring and control ………………………………………………………………………………………….. 23
11 Product release from sterilization……………………………………………………………………………………….. 24
12 Maintaining process effectiveness ……………………………………………………………………………………… 24
12.1 General………………………………………………………………………………………………………………………………. 24
12.2 Maintenance of equipment …………………………………………………………………………………………………. 24
12.3 Requalification …………………………………………………………………………………………………………………… 24
12.4 Assessment of change……………………………………………………………………………………………………….. 25
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach…………………………………………………………………………………………….. 26
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach……………………………………………………………………………………………………………….. 28
Annex C (informative) General guidance…………………………………………………………………………………………. 30
Bibliography………………………………………………………………………………………………………………………………….. 46
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices ………………………………………………………………. 47
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach ………………………………………………………………………………………. 26
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach ………………………………………………………………………………………………………… 28
Annex C (informative) General guidance ……………………………………………………………………………………… 30
Bibliography ……………………………………………………………………………………………………………………………….. 46
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical devices …………………………………………….. 47
Normative references ……………………………………………………………………………………………………………………. 7