EN ISO 20857:2013

Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.
Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

Sterilisation von Produkten für die Gesundheitsfürsorge - Trockene Hitze - Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung von industriellen Sterilisationsverfahren für Medizinprodukte (ISO 20857:2010)

1.1   In den Anwendungsbereich einbezogen
1.1.1   Diese Internationale Norm legt Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung von Sterilisationsverfahren für Medizinprodukte mit trockener Hitze fest.
ANMERKUNG   Obwohl sich der Anwendungsbereich dieser Internationalen Norm auf Medizinprodukte beschränkt, legt er Anforderungen fest und bietet Anleitungen, die auf andere Produkte der Gesundheitsfürsorge anwendbar sein können.
1.1.2   Obwohl diese Internationale Norm in erster Linie die Sterilisation mit trockener Hitze betrifft, legt sie auch Anforderungen fest und bietet Anleitungen für Entpyrogenisierungsverfahren mit trockener Hitze.
ANMERKUNG   Trockene Hitze wird häufig bei der Entpyrogenisierung von Ausrüstungen/Anlagen, Komponenten und Produkten der Gesundheitsfürsorge angewendet, und deren Wirksamkeit wurde nachgewiesen. Die Prozessparameter für die Sterilisation und/oder Entpyrogenisierung sind Zeitdauer und Temperatur. Weil die Bedingungen für die Entpyrogenisierung gewöhnlich strenger sind als jene, die bei der Sterilisation erforderlich sind, ergibt ein Verfahren, das für die Entpyrogenisierung von Produkten validiert wurde, eine Produktsterilität ohne zusätzliche Validierung.
1.2   In den Anwendungsbereich nicht einbezogen
1.2.1   Diese Internationale Norm legt keine Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Verfahrens zur Inaktivierung der Erreger von spongiformen Enzephalopathien, wie z. B. der Scrapie-Krankheit (Traberkrankheit), der spongiformen Rinderenzephalopathie (BSE) und Creutzfeldt-Jakob-Krankheit fest.
ANMERKUNG   Siehe auch ISO 22442-1, ISO 22442-2 und ISO 22442-3.
1.2.2   Diese Internationale Norm gilt nicht für Verfahren, bei denen Infrarot  oder Mikrowellen als Heiztechnik zum Einsatz kommen.
1.2.3   Diese Internationale Norm enthält keine detaillierten Angaben zu einer bestimmten Anforderung, wann ein Medizinprodukt als „steril“ zu bezeichnen ist.
ANMERKUNG   Es wird auf nationale oder regionale Anforderungen an die Bezeichnung eines Medizinprodukts als „steril“ verwiesen. Siehe z. B. EN 556-1 oder ANSI/AAMI ST67.
1.2.4   Diese Internationale Norm legt kein Qualitätsmanagementsystem für die Lenkung aller Produktionsphasen von Medizinprodukten fest.
ANMERKUNG   Die vorliegende Internationale Norm enthält keine Forderung, die während der Herstellung ein lückenloses Qualitätsmanagementsystem verlangt, jedoch müssen die mindestens notwendigen Elemente eines Qualitätsmanagementsystems für die Lenkung des Sterilisationsverfahrens vorliegen, auf die an entsprechenden Stellen des Textes normativ Bezug genommen wird (siehe besonders Abschnitt 4). Zu beachten sind die Normen zu Qualitätsmanagementsystemen (siehe ISO 13485), die alle Stufen der Herstellung von Medizinprodukten einschließlich Sterilisationsverfahren lenken. Nationale und/oder regionale Bestimmungen für die Bereitstellung von Medizinprodukten verlangen möglicherweise die Umsetzung eines vollständigen Qualitätsmanagementsystems und die Beurteilung dieses Systems durch Dritte.
1.2.5   Diese Internationale Norm legt keine Anforderungen an den Arbeitsschutz im Zusammenhang mit Konstruktion und Betrieb von Sterilisations  und/oder Entpyrogenisierungsanlagen mit trockener Hitze fest.
ANMERKUNG   Anforderungen an die Betriebssicherheit sind in IEC 61010 2 040 festgelegt. In einigen Ländern existieren zusätzliche Sicherheitsbestimmungen.

Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux (ISO 20857:2010)

L'ISO 20857:2010 spécifie les exigences concernant l'élaboration, la validation et le contrôle de routine d'un procédé de stérilisation à la chaleur sèche pour dispositifs médicaux.
Bien que l'ISO 20857:2010 concerne principalement la stérilisation à la chaleur sèche, elle spécifie également des exigences et fournit des lignes directrices en ce qui concerne les procédés de dépyrogénisation utilisant la chaleur sèche.

Sterilizacija izdelkov za zdravstveno nego - Suha toplota - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 20857:2010)

Ta mednarodni standard določa zahteve za razvoj, validacijo in rutinsko kontrolo postopkov sterilizacije s suho toploto za medicinske pripomočke. Ta mednarodni standard prvenstveno obravnava sterilizacijo s suho toploto, vendar določa tudi zahteve in podaja napotke v zvezi s postopki depirogenacije s suho toploto.

General Information

• Status: Published
• Publication Date: 16-Apr-2013
• Withdrawal Date: 30-Oct-2013
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 1 - Ethylene oxide sterilization
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 17-Apr-2013
• Due Date: 21-Dec-2013
• Completion Date: 17-Apr-2013
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 20857:2013 - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2013
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR6XKDWRSORWD=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH,62
Sterilization of health care products - Dry heat - Requirements for the development,
validation and routine control of a sterilization process for medical devices (ISO
20857:2010)
Sterilisation von Produkten für die Gesundheitsfürsorge - Trockene Hitze -
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 20857:2010)
Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la
validation et le contrôle de routine d'un processus de stérilisation pour dispositifs
médicaux (ISO 20857:2010)
Ta slovenski standard je istoveten z: EN ISO 20857:2013
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 20857
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2013
ICS 11.080.01
English Version
Sterilization of health care products - Dry heat - Requirements
for the development, validation and routine control of a
sterilization process for medical devices (ISO 20857:2010)
Stérilisation des produits de santé - Chaleur sèche - Sterilisation von Produkten für die Gesundheitsfürsorge -
Exigences pour l'élaboration, la validation et le contrôle de Trockene Hitze - Anforderungen an die Entwicklung,
routine d'un processus de stérilisation pour dispositifs Validierung und Lenkung der Anwendung von industriellen
médicaux (ISO 20857:2010) Sterilisationsverfahren für Medizinprodukte (ISO
20857:2010)
This European Standard was approved by CEN on 5 April 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20857:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices .4
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .5
Annex ZC (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices .6

Foreword
The text of ISO 20857:2010 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 EN ISO
20857:2013 by 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 October 2013, and conflicting national standards shall be withdrawn at
the latest by October 2013.
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.
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 Directives.
For relationship with EU Directives, see informative Annex ZA, B and C, which are integral parts 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, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 20857:2010 has been approved by CEN as EN ISO 20857:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EEC on Active Implantable Medical
Devices
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 90/385/EEC on active implantable medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 90/385/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 90/385/EEC
4,5,6,7,8,9,10,11,12 7 This relevant Essential Requirement is
only partly addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not

covered
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
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 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZB.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZB.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 93/42/EEC
4,5,6,7,8,9,10,11,12 8.3 This relevant Essential Requirement is
only partly addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not
covered
4,5,6,7,8,9,10,11,12 8.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.
Annex ZC
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 98/79/EC on in vitro diagnostic medical
devices
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 98/79/EC on in vitro diagnostic medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZC.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZC.1 — Correspondence between this European Standard and Directive 98/79/EC
Clauses of this EN Essential Requirements (ERs) of Qualifying remarks/Notes
Directive 98/79/EC
4,5,6,7,8,9,10,11,12 B.2.3 This relevant Essential Requirement is
only partly addressed in this European
Standard. Packaging for
maintenance of sterility during
transportation and storage are not

covered
4,5,6,7,8,9,10,11,12 B.2.4
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this Standard.

INTERNATIONAL ISO
STANDARD 20857
First edition
2010-08-15
Sterilization of health care products —
Dry heat — Requirements for the
development, validation and routine
control of a sterilization process for
medical devices
Stérilisation des produits de santé — Chaleur sèche — Exigences pour
l'élaboration, la validation et le contrôle de routine d'un processus de
stérilisation pour dispositifs médicaux

Reference number
ISO 20857:2010(E)
©
ISO 2010
ISO 20857:2010(E)
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ISO 20857:2010(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 .2
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 nonconforming product.10
5 Sterilizing agent characterization.
...