Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
Abstract
ISO 14937:2009 specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.
DIN EN ISO 14937:2010-03 (E)
Sterilization of health care products – General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization
process for medical devices (ISO 14937:2009)
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 ……………………………………………………………………………………………………..8
4 Quality management system elements …………………………………………………………………………..13
4.1 Documentation ……………………………………………………………………………………………………………..13
4.2 Management responsibility ……………………………………………………………………………………………13
4.3 Product realization ………………………………………………………………………………………………………..14
4.4 Measurement, analysis and improvement — Control of non-conforming product …………….14
5 Sterilizing agent characterization …………………………………………………………………………………..14
5.1 General …………………………………………………………………………………………………………………………14
5.2 Sterilizing agent …………………………………………………………………………………………………………….14
5.3 Microbicidal effectiveness …………………………………………………………………………………………….14
5.4 Effects on materials ………………………………………………………………………………………………………15
5.5 Safety and the environment …………………………………………………………………………………………..15
6 Process and equipment characterization ……………………………………………………………………….15
6.1 General …………………………………………………………………………………………………………………………15
6.2 Process characterization ……………………………………………………………………………………………….15
6.3 Equipment characterization …………………………………………………………………………………………..16
7 Product definition ………………………………………………………………………………………………………….16
8 Process definition …………………………………………………………………………………………………………17
9 Validation ……………………………………………………………………………………………………………………..18
9.1 General …………………………………………………………………………………………………………………………18
9.2 Installation qualification ………………………………………………………………………………………………..18
9.3 Operational qualification ……………………………………………………………………………………………….19
9.4 Performance qualification ……………………………………………………………………………………………..19
9.5 Review and approval of validation …………………………………………………………………………………20
10 Routine monitoring and control …………………………………………………………………………………….20
11 Product release from sterilization ………………………………………………………………………………….20
12 Maintaining process effectiveness …………………………………………………………………………………21
12.1 General …………………………………………………………………………………………………………………………21
12.2 Recalibration …………………………………………………………………………………………………………………21
12.3 Maintenance of equipment …………………………………………………………………………………………….21
12.4 Requalification …………………………………………………………………………………………………………….. 21
12.5 Assessment of change ………………………………………………………………………………………………… 21
Annex A (normative) Factors to be considered in selection of microorganisms for demonstrating
microbicidal effectiveness ……………………………………………………………………………………………. 22
Annex B (normative) Approach 1 — Process definition based on inactivation of the microbial
population in its natural state ………………………………………………………………………………………. 24
Annex C (normative) Approach 2 — Process definition based on inactivation of reference
microorganisms and knowledge of bioburden ……………………………………………………………… 25
Annex D (normative) Approach 3 — Conservative process definition based on inactivation of
reference microorganisms …………………………………………………………………………………………… 26
Annex E (informative) Guidance on application of this International Standard ……………………………… 28
Bibliography ……………………………………………………………………………………………………………………………….. 42
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices ………… 44
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices ……………………………………….. 45
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices …………….. 46