SIST-TS CEN ISO/TS 17665-2:2009
(Main)Sterilization of health care products - Moist heat - Part 2: Guidance on the application of 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)
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von ISO 17665-1 (ISO 17665-2:2009)
Diese Technische Spezifikation liefert einen allgemeinen Leitfaden zur Entwicklung, Validierung und Lenkung
der Anwendung von Sterilisationsverfahren mit feuchter Hitze und ist vorgesehen, die in ISO 17665-1
dargelegten Anforderungen zu erläutern. Der in der vorliegenden Technischen Spezifikation vorgelegte
Leitfaden ist vorgesehen, bewährte Praktiken in Bezug auf Sterilisationsverfahren mit feuchter Hitze zu
fördern und diejenigen zu unterstützen, die ein Sterilisationsverfahren mit feuchter Hitze nach ISO 17665-1
entwickeln und validieren.
ANMERKUNG 1 Die Gliederung des Hauptteils der vorliegenden Technischen Spezifikation (Abschnitt 1 bis
Abschnitt 12) entspricht der Gliederung von ISO 17665-1, daher passt der unter einem bestimmten Abschnitt von diesem
Teil von ISO 17665 gegebene Leitfaden zu den im entsprechenden Abschnitt von ISO 1776-1 aufgeführten
Anforderungen. Z. B. ist ein für Abschnitt 5.2 von ISO 17665-1:2006 gegebener Leitfaden in ISO/TS 17665-2 in 5.2 zu
finden. Dieser Leitfaden wird zusätzlich zu dem in Anhang A von ISO 17665-1:2006 gegebenen Leitfaden vorgelegt.
ANMERKUNG 2 In Anhang D werden besondere Hinweise gegeben, die speziell für Sterilisationsverfahren zutreffen,
die in der Gesundheitsfürsorge durchgeführt werden.
Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à l'application de l'ISO 17665-1 (ISO 17665-2:2009)
L'ISO/TS 17665-2:2009 fournit des directives générales sur le développement, la validation et le contrôle de routine de procédés de stérilisation par chaleur humide, et vise à expliquer les exigences présentées dans l'ISO 17665-1. Les directives fournies dans l'ISO/TS 17665-2:2009 sont destinées à promouvoir les bonnes pratiques relatives aux procédés de stérilisation par chaleur humide et à faciliter le développement et la validation d'un procédé de stérilisation par chaleur humide conforme à l'ISO 17665-1.
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - 2. del: Navodilo za uporabo ISO 17665-1 (ISO 17665-2:2009)
General Information
Relations
Standards Content (Sample)
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
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