Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
Abstract
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
- saturated steam venting systems;
- saturated steam active air removal systems;
- air steam mixtures;
- water spray;
- water immersion.
DIN EN ISO 17665-1:2006-11 (E)
Sterilization of health care products – Moist heat – Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical
devices (ISO 17665-1:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….4
Introduction ……………………………………………………………………………………………………………………………………5
1 Scope ……………………………………………………………………………………………………………………………..7
1.1 Inclusions ……………………………………………………………………………………………………………………….7
1.2 Exclusions ……………………………………………………………………………………………………………………..7
2 Normative references ……………………………………………………………………………………………………..8
3 Terms and definitions ……………………………………………………………………………………………………..9
4 Quality management system elements …………………………………………………………………………..16
4.1 Documentation ……………………………………………………………………………………………………………..16
4.2 Management responsibility ……………………………………………………………………………………………16
4.3 Product realization ………………………………………………………………………………………………………..16
4.4 Measurement, analysis and improvement — Control of non-conforming product …………….16
5 Sterilizing agent characterization …………………………………………………………………………………..17
5.1 Sterilizing agent …………………………………………………………………………………………………………….17
5.2 Microbicidal effectiveness …………………………………………………………………………………………….17
5.3 Materials effects ……………………………………………………………………………………………………………17
5.4 Environmental consideration …………………………………………………………………………………………17
6 Process and equipment characterization ……………………………………………………………………….17
6.1 Process ………………………………………………………………………………………………………………………..17
6.1.1 General …………………………………………………………………………………………………………………………17
6.1.2 Saturated steam processes …………………………………………………………………………………………..18
6.1.3 Contained product processes ……………………………………………………………………………………….18
6.2 Equipment …………………………………………………………………………………………………………………….19
7 Product definition ………………………………………………………………………………………………………….20
8 Process definition …………………………………………………………………………………………………………21
9 Validation ……………………………………………………………………………………………………………………..23
9.1 General …………………………………………………………………………………………………………………………23
9.2 Installation qualification (IQ) ………………………………………………………………………………………….23
9.2.1 Equipment …………………………………………………………………………………………………………………….23
9.2.2 Installation ……………………………………………………………………………………………………………………23
9.2.3 Function ……………………………………………………………………………………………………………………….23
9.3 Operational qualification (OQ) ……………………………………………………………………………………….24
9.4 Performance qualification (PQ) ……………………………………………………………………………………..24
9.5 Review and approval of validation …………………………………………………………………………………25
10 Routine monitoring and control …………………………………………………………………………………….26
11 Product release from sterilization ………………………………………………………………………………….27
12 Maintaining process effectiveness ……………………………………………………………………………….. 27
12.1 Demonstration of continued effectiveness ……………………………………………………………………. 27
12.2 Recalibration ……………………………………………………………………………………………………………….. 27
12.3 Maintenance of equipment …………………………………………………………………………………………… 27
12.4 Requalification …………………………………………………………………………………………………………….. 28
12.5 Assessment of change ………………………………………………………………………………………………… 28
Annex A (informative) Guidance ………………………………………………………………………………………………….. 29
Annex B (informative) Process definition based on inactivation of the microbial population in its
natural state (bioburden-based method) ………………………………………………………………………. 33
Annex C (informative) Process definition based on the inactivation of a reference microorganism
and a knowledge of bioburden on product items to be sterilized (combined
bioburden/biological indicator based method) ……………………………………………………………… 34
Annex D (informative) Conservative process definition based on inactivation of reference
microorganisms (overkill method) ………………………………………………………………………………… 35
Annex E (informative) Operating cycles ……………………………………………………………………………………….. 37
Bibliography ……………………………………………………………………………………………………………………………….. 42
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC, 93/42/EEC and 98/79/EEC ………………………….. 45