SIST EN ISO 17665:2024
(Main)Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 17665:2024)
Dieses Dokument enthält Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung von Verfahren für die Sterilisation von Medizinprodukten durch feuchte Hitze. Die Norm enthält außerdem Leitfäden, die die in den normativen Abschnitten dargelegten Anforderungen erläutern sollen. Die vorgelegten Leitfäden sind dafür vorgesehen, bewährte Praktiken in Bezug auf Sterilisationsverfahren mit feuchter Hitze, die diesem Dokument entsprechen, zu unterstützen. Die Anwendung in industriellen Umgebungen und in Einrichtungen der Gesundheitsfürsorge wird berücksichtigt.
1.1 Im Anwendungsbereich enthalten
1.1.1 Zu den durch dieses Dokument erfassten Sterilisationsverfahren mit feuchter Hitze gehören, ohne darauf begrenzt zu sein:
a) Sterilisation mit gesättigtem Dampf, bei der Luft durch Dampf verdrängt wird;
b) Sterilisation mit gesättigtem Dampf, bei der Luft durch aktive Entlüftung (Zwangsentlüftung) entfernt wird;
c) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Dampf-Luft-Gemische erreicht wird;
d) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Wasserberieselung erreicht wird;
e) Sterilisation eingeschlossener Produkte, bei der die Wärmeübertragung durch Eintauchen in Wasser erreicht wird.
ANMERKUNG 1 Siehe Anhang D, in dem die Verfahren eingehender erläutert werden.
ANMERKUNG 2 Obgleich der Anwendungsbereich dieses Dokuments auf Medizinprodukte begrenzt ist, legt es Anforderungen fest und gibt Anleitungen, die auf weitere Produkte für die Gesundheitsfürsorge und industrielle Anwendungen anwendbar sein können.
Stérilisation des produits de santé - Chaleur humide - Exigences pour le développement, la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs médicaux (ISO 17665:2024)
Le présent document spécifie les exigences relatives au développement, à la validation et au contrôle de routine des procédés de stérilisation des dispositifs médicaux à la chaleur humide. Il contient également des recommandations destinées à expliquer les exigences spécifiées dans les sections normatives. Les recommandations fournies sont destinées à promouvoir les bonnes pratiques relatives aux procédés de stérilisation à la chaleur humide conformément au présent document. Les applications dans les installations industrielles et les établissements de soins de santé sont prises en considération.
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 17665:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 17665:2024
01-julij-2024
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO 17665:2024)
Sterilization of health care products - Moist heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO
17665:2024)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 17665:2024)
Stérilisation des produits de santé - Chaleur humide - Exigences pour le développement,
la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs
médicaux (ISO 17665:2024)
Ta slovenski standard je istoveten z: EN ISO 17665:2024
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 17665:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 17665:2024
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SIST EN ISO 17665:2024
EN ISO 17665
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17665-1:2006, CEN ISO/TS 17665-
2:2009
English Version
Sterilization of health care products - Moist heat -
Requirements for the development, validation and routine
control of a sterilization process for medical devices (ISO
17665:2024)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die
Exigences pour le développement, la validation et le Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
contrôle de routine d'un procédé de stérilisation des an die Entwicklung, Validierung und Lenkung der
dispositifs médicaux (ISO 17665:2024) Anwendung eines Sterilisationsverfahrens für
Medizinprodukte (ISO 17665:2024)
This European Standard was approved by CEN on 3 December 2023.
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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17665:2024 E
worldwide for CEN national Members.
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SIST EN ISO 17665:2024
EN ISO 17665:2024 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 9
2
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SIST EN ISO 17665:2024
EN ISO 17665:2024 (E)
European foreword
This document (EN ISO 17665:2024) 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 publ
...
SLOVENSKI STANDARD
oSIST prEN ISO 17665:2022
01-november-2022
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - Zahteve za razvoj,
validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske
pripomočke (ISO/DIS 17665:2022)
Sterilization of health care products - Moist heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO/DIS
17665:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Anforderungen
an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO/DIS 17665:2022)
Stérilisation des produits de santé - Chaleur humide - Exigences pour le développement,
la validation et le contrôle de routine d’un procédé de stérilisation des dispositifs
médicaux (ISO/DIS 17665:2022)
Ta slovenski standard je istoveten z: prEN ISO 17665
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 17665:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 17665:2022
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oSIST prEN ISO 17665:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17665
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-09-01 2022-11-24
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
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WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 17665
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
Sterilization of health care products — Moist heat —
Requirements for the development, validation and routine
control of a sterilization process for medical devices
ICS: 11.080.01
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
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NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
© ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 17665:2022
ISO/DIS 17665:2022(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope .
...
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