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SLOVENSKI STANDARD
01-april-2009
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - 2. del: Navodilo za
uporabo ISO 17665-1 (ISO 17665-2:2009)
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of
ISO 17665-1 (ISO 17665-2:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2:
Leitfaden für die Anwendung von ISO 17665-1 (ISO 17665-2:2009)
Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à
l'application de l'ISO 17665-1 (ISO 17665-2:2009)
Ta slovenski standard je istoveten z: CEN ISO/TS 17665-2:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL SPECIFICATION
CEN ISO/TS 17665-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
January 2009
ICS 11.080.01
English Version
Sterilization of health care products - Moist heat - Part 2:
Guidance on the application of ISO 17665-1 (ISO 17665-2:2009)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 2: Directives relatives à l'application de l'ISO 17665- Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von
1 (ISO 17665-2:2009) ISO 17665-1 (ISO 17665-2:2009)
This Technical Specification (CEN/TS) was approved by CEN on 23 November 2008 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 17665-2:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (CEN ISO/TS 17665-2:2009) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" of the International Organization for Standardization (ISO) and has been
taken over as CEN/TS ISO 17665-2:2009 by Technical Committee CEN/TC 204 “Sterilization of medical
devices” the secretariat of which is held by BSI.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 17665-2:2009 has been approved by CEN as a CEN/TS ISO 17665-2:2009 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 17665-2
First edition
2009-01-15
Sterilization of health care products —
Moist heat —
Part 2:
Guidance on the application
of ISO 17665-1
Stérilisation des produits de santé — Chaleur humide —
Partie 2: Directives relatives à l'application de l'ISO 17665-1
Reference number
ISO/TS 17665-2:2009(E)
©
ISO 2009
ISO/TS 17665-2:2009(E)
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ISO/TS 17665-2:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Quality management system elements .2
5 Sterilizing agent characterization . 2
5.1 Sterilizing agent . 2
5.2 Microbicidal effectiveness . 2
5.3 Material effects. 3
5.4 Environmental considerations . 3
6 Process and equipment characterization .3
6.1 Process . 3
6.2 Equipment . 6
7 Product definition . 7
8 Process definition. 8
9 Validation. 10
9.1 General. 10
9.2 Installation qualification (IQ) . 11
9.3 Operational qualification (OQ). 11
9.4 Performance qualification (PQ) . 13
9.5 Review and approval of the validation . 14
10 Routine monitoring and control . 15
11 Product release from sterilization. 16
12 Maintaining process effectiveness . 17
12.1 Demonstration of continued effectiveness. 17
12.2 Recalibration . 17
12.3 Maintenance of equipment . 17
12.4 Requalification . 17
12.5 Assessment of change. 18
Annex A (informative) Evaluation of a sterilization process primarily based on the measurement
of physical parameters. 19
Annex B (informative) Evaluation of a sterilization process primarily based on biological
inactivation and an accompanying mechanical air removal procedure . 27
Annex C (informative) Temperature and pressure of saturated steam for use in moist heat
sterilization . 30
Annex D (informative) Special considerations for health care settings . 32
Annex E (informative) Index of normative clauses/subclauses of ISO 17665-1 and cited references
or related guidance given in ISO 17665-1 and ISO/TS 17665-2. 41
Bibliography . 44
ISO/TS 17665-2:2009(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
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an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held res
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