Sterilizationofhealthcare products--Moistheat- validation androutinecontrolof Requirementsforthedevelopment asterilizationprocessformedical devices
Sterilisation des produits de sante - Chaleur humide-Exigences pour le developpement la validation et le controle de routine d’un procede de sterilisation des dispositifs medicaux
InternationalStandard
First edition2024-03
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Oc ISO 2024
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ISO 17665:2024(en)
Contents
PageForeword.Introduction.... .VScope....1.1 1.2 Inclusions. Exclusions. 12 Normative references. 2 T"3 Terms and definitions. 24 General.. .125 Steriliing agent characterization. 5.1 Sterilizing agent. 13 135.2 Microbicidal effectiveness... 145.3 5.4 Effects on materials. Environmental consideration.. 14 14Process and equipment characterization. 146.1 6.2 General. Process characterization. 14 146.3 Saturated steam sterilization processes. 156.5 6.4 Contained product sterilization processes. Equipment. 16 .177 Product definition.. 188 Process definition.. 209 Validation. 9.1 22 229.2 Installation qualification (Q. General. 236 9.4 Performance qualification (PQ) Operational qualification (0Q) 23 .249.5 Review and approval of validation... 2610 Routine monitoring and control. 10.1 Routine monitoring. 26 2610.2 Operational status. 2610.4 10.3 Process verification Evaluation of additional data for saturated steam sterilization processes. .27 2710.5 10.6 Evaluation of additional data for contained product sterilization processes. Record retention.. .28 2711 Product release from sterilization... .2812 Maintaining process effectivenes..... .2812.1 12.2 Purpose.. Demonstration of continued effectiveness... .28 2812.3 Recalibration... 2912.4 12.5 Requalification Equipment maintenance.. 29 2912.6 Assessment of change. 30Annex A (informative) Guidance on the principles of moist heat sterilization and rationales for requirements... ...31.Annex B (informative) Establishment and evaluation of a sterilization process primarily basedon microbiological inactivation.. 59Annex C (informative) Establishment and evaluation ofa sterilization process primarily based on the measurement of physical parameter.... 73
ISO 17665:2024(en)
Annex D (informative) Examples of moist heat sterilization cycles. .83Annex E (informative) Temperature and pressure of saturated steam for use in moist heat sterilization.... ..89Annex F (informative) Guidance on the application of the normative requirements in healthcare facilities....... .93Annex G (informative) Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat. 118Annex H (informative) Guidance on the application of the normative requirements in industrialsettings.. 126Bibliography. 150
ISO 17665:2024(en)
Foreword
bodies (ISO member bodies). The work of preparing International Standards is normally carried out throughhas been established has the right to be represented on that mittee. International organizations ISO technical mittees. Each member body interested in a subject for which a technical mitteegovernmental and non-governmental in liaison with ISO also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are describedin the ISO/IEC Directives Part 1. In particular the different approval criteria needed for the different typesof ISO document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives Part 2 (see
rights in respect thereof. As of the date of publication of this document ISo had not received notice of (a) patent(s) which may be required to implement this document. However implementers are cautioned that ISO shall not be held responsible for identifying any or all such patent rights. this may not represent the latest information which may be obtained from the patent database available at
Any trade name used in this document is information given for the convenience of users and does notconstitute an endorsement.
For an explanation of the voluntary nature of standards the meaning of ISO specific terms and expressionsrelated to conformity assessment as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
This document was prepared by Technical Committe ISO/TC 198 Sterilization of health care products incollaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 204 Sterilization of medical devices in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This first edition cancels and replaces ISO 17665-1:2006 ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013 which have been technically revised.
The main changes pared to the previous editions are as follows:
bined ISO 17665-1 ISO/TS 17665-2 and ISO/TS 17665-3 into a single standard.
A list of all parts in the ISO 17665 series can be found on the ISO website.
plete listing of these bodies can be found at
