Sterilization ofhealthcareproducts-Moist heat
Part 1:
Requirements for development validation androutine control ofa sterilizationprocessformedicaldevices.
ContentsContentsPageForewordAIntroductionvi1 Scope 11.1 Inclusions 11.2 Exclusions2 Normative references 123 Terms and definitions 34 Qualitymanagement system elements4.1 Documentation 10Management responsibility 104.2 104.3 Product realization 104.4 Measurement analysis and improvement-Control of non-conforming product 105 Sterilizing agent characterizationSterilizing agent 115.1 115.2 Microbicidal effectiveness 115.3 Materials effects 115.4 Environmental consideration6 Process and equipment characterization 11Process 116.1 116.1.1 General 116.1.2 Saturated steam processes 126.1.3 Contained product processes6.2 Equipment 12137 Product definition 148 Process definition15
9 Validation 179.1 General9.2 Installation qualification (IQ) 179.2.1 Equipment 179.2.2 Installation 17179.2.3 Function 179.3 Operational qualification (OQ) 189.4 Performance qualification (PQ) 189.5 Review and approval of validation10 Routine monitoring and control 192011 Product release from sterilization 2112 Maintaining process effectiveness2112.1 Demonstrationofcontinuedeffectiveness 2112.2 Recalibration 2112.3 Maintenance of equipment 2112.4 Requalification12.5 Assessment of change 2222Annex A (informative) Guidance
Annex B (informative) Process definition based on inactivation of the microbial population in itsnatural state (bioburden-based method) .27
reference microorganism and aknowledge of thebioburden per unit of the product to be sterilized(bioburden based methodCombined/Biological Indicator)... 28Annex D (informative) Definition of the conservation process based onon the inactivation of reference microorganisms (overkill method) 29Annex E(informative)Operational cycles.. 31Annex ZA(informative) Relationshipbetween this International Standard and the essentialrequirementsof EU Directives90/385/EECof 20June 1990on actively implantable medicaldevices 93/42/EEC of 14June 1993 on medical devices and 98/79/EC of 7December 1988 on medical devicesDiagnostic in Vitro... .36Bibliography. .37Notes Explanatory.. .40
Foreword
ISO (The International Organization for Standardization) is a worldwide federation of national standardsbodies (member bodies of ISO). The task of preparing International Standards is normally carried out throughset up shall have the right to be represented on that mittee. Intermational organizations governmental and ISO technical mittees. Any member body interested in a matter for which a technical mittee has beennon-governmental in collaboration with ISO also take part in the work. ISO cooperates closely with the Intermational Electrotechnical Commission (IEC) on all matters related to electrotechnical standardization.
Intermational standards are drawn up in accordance with the rules given in the ISO/IEC Directives Part 2.
The main task of the technical mittees is to prepare international standards. Draft intermational standardsadopted by the technical mittes were circulated among member bodies for voting. Publication as an international standard requires the approval of at least 75% of member bodies with a decisive vote.
rights. ISO should not be held responsible for identifying anyone or allof these patent rights.
ISO 17665-1 was prepared by the ISO/TC 198 Technical Committee Sterilization of Health Care Products.
The first edition of ISO 17665-1 repeals and replaces ISO 11134:1994 and ISO 13683:1996 both of which have been technically revised.
ISO 17665 consists of the following parts under the general title Sterilization of sanitarf products Moist heat.'
Part 1. Requirements for the Development Validation and Routine Control of α Medical DeviceSterilization Process-Part 2. ISO 17665-1 Application Guide
