|
SLOVENSKI STANDARD
01-oktober-2006
1DGRPHãþD
SIST EN 554:2000
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR9ODåQDWRSORWDGHO =DKWHYH]D
UD]YRMYDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH ,62
Sterilization of health care products - Moist heat - Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
(ISO 17665-1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 17665-1:2006)
Stérilisation des produits de santé - Chaleur humide - Partie 1: Exigences pour le
développement, la validation et le contrôle de routine d'un procédé de stérilisation des
dispositifs médicaux (ISO 17665-1:2006)
Ta slovenski standard je istoveten z: EN ISO 17665-1:2006
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.
EUROPEAN STANDARD
EN ISO 17665-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2006
ICS 11.080.01 Supersedes EN 554:1994
English Version
Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine
control of a sterilization process for medical devices (ISO 17665-
1:2006)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences pour le développement, la validation et Feuchte Hitze - Teil 1: Anforderungen an die Entwicklung,
le contrôle de routine d'un procédé de stérilisation des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 17665-1:2006) Sterilisationsverfahrens für Medizinprodukte (ISO 17665-
1:2006)
This European Standard was approved by CEN on 14 July 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17665-1:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 17665-1:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
"Sterilization of medical devices", the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by February 2007, and conflicting national standards
shall be withdrawn at the latest by August 2009.
This document supersedes EN 554:1994.
This document has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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.
Endorsement notice
The text of ISO 17665-1:2006 has been approved by CEN as EN ISO 17665-1:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC, 93/42/EEC and 98/79/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive EU Directives 90/385/EEC, 93/42/EEC and
98/79/EC.
Once this European Standard is cited in the Official Journal of the European Communities under
that Directive and has been implemented as a national standard in at least one Member State,
compliance with the normative clauses of this standard, as shown in Table ZA.1, confers, within the
limits of the scope of this standard, a presumption of conformity with the relevant Essential
Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and Directives 90/385/EEC,
93/42/EEC and 98/79/EC
Clause(s)/Sub- Essential Essential Essential Qualifying
clause(s) of this EN Requirements Requirements Requirements remarks/
(ERs) of (ERs) of (ERs) of Notes
Directive Directive Directive
90/385/EEC 93/42/EEC 98/79/EC
In part
4, 5, 6, 7, 8, 9, 10, 7 8.3 B.2.3
11, 12
In part
4, 5, 6, 7, 8, 9, 10, 8.4 B.2.4
11, 12
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this European Standard.
INTERNATIONAL ISO
STANDARD 17665-1
First edition
2006-08-15
Sterilization of health care products —
Moist heat —
Part 1:
Requirements for the development,
validation and routine control of a
sterilization process for medical devices
Stérilisation des produits de santé — Chaleur humide —
Partie 1: Exigences pour le développement, la validation et le contrôle
de routine d'un procédé de stérilisation des dispositifs médicaux
Reference number
ISO 17665-1:2006(E)
©
ISO 2006
ISO 17665-1:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [email protected]
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
ISO 17665-1:2006(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 2
3 Terms and definitions. 3
4 Quality management system elements . 10
4.1 Documentation. 10
4.2 Management responsibility . 10
4.3 Product realization. 10
4.4 Measurement, analysis and improvement — Control of non-conforming product . 10
5 Sterilizing agent characterization . 11
5.1 Sterilizing agent . 11
5.2 Microbicidal effectiveness . 11
5.3 Materials effects. 11
5.4 Environmental consideration . 11
6 Process and equipment characterization . 11
6.1 Process . 11
6.1.1 General. 11
6.1.2 Saturated steam processes . 12
6.1.3 Contained product processes . 12
6.2 Equipment . 13
7 Product definition . 14
8 Process definition. 15
9 Validation. 17
9.1 General. 17
9.2 Installation qualification (IQ) . 17
9.2.1 Equipment . 17
9.2.2 Installation . 17
9.2.3 Function. 17
9.3 Operational qualification (OQ). 18
9.4 Performance qualification (PQ) . 18
9.5 Review and approval of validation. 19
10 Routine monitoring and control . 20
11 Product release from sterilization. 21
12 Maintaining process effectiveness . 21
12.1 Demonstration of continued effectiveness. 21
12.2 Recalibration . 21
12.3 Maintenance of equipment . 21
12.4 Requalification . 22
12.5 Assessment of change.
...