BS EN ISO 17665-1:2006

Foreword
Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management system elements
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control
        of non-conforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Materials effects
   5.4 Environmental consideration
6 Process and equipment characterization
   6.1 Process
        6.1.1 General
        6.1.2 Saturated steam processes
        6.1.3 Contained product processes
   6.2 Equipment
7 Product definition
8 Process definition
9 Validation
   9.1 General
   9.2 Installation qualification (IQ)
        9.2.1 Equipment
        9.2.2 Installation
        9.2.3 Function
   9.3 Operational qualification (OQ)
   9.4 Performance qualification (PQ)
   9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 Demonstration of continued effectiveness
   12.2 Recalibration
   12.3 Maintenance of equipment
   12.4 Requalification
   12.5 Assessment of change
Annex A (informative) Guidance
Annex B (informative) Process definition based on
         inactivation of the microbial population in
         its natural state (bioburden-based method)
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)
Annex D (informative) Conservative process definition
         based on inactivation of reference microorganisms
         (overkill method)
Annex E (informative) Operating cycles
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC, 93/42/EEC and 98/79/EEC
Bibliography

Defines requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: saturated steam venting systems; saturated steam active air removal systems; air steam mixtures; water spray; water immersion. NOTE See also Annex E. 1.2 Exclusions 1.2.1 This part of ISO 17665 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.2 This part of ISO 17665 does not apply to those sterilization processes that are based on a combination of moist heat with other biocidal agents (e.g. formaldehyde) as the sterilizing agent. 1.2.3 This part of ISO 17665 does not detail a specified requirement for designating a medical device as “sterile.” NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67. 1.2.4 This part of ISO 17665 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 part of ISO 17665 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, Clause 4). 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 might require implementation of a complete quality management system and the assessment of that system by a third party. 1.2.5 This part of ISO 17665 does not specify requirements for occupational safety associated with the design and operation of moist heat sterilization facilities. NOTE Requirements for operational safety are specified in IEC 61010-2-040. Additionally, safety regulations exist in some countries.