EN ISO 11135-1:2007

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

CEN/TC 204 resolution 5/2005 requested an extension of DOW.  (DAV + 36 months)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Corresponds to the revision of  ISO 11135:1994. ISO reference ISO 11135 (draft ++ BP - TA/990611) ++ TC letter of 990818: NO TD until it has been discussed and agreed in the relevan ++ t ISO/WG (TA/990825) ++ New TD in BP but will change when ISO will have given TD (bli 000121) ++ Revision of EN 550:1994 (TC/BP - CC/000314)
ISO have split ISO 11135 into 2 documents. CEN/TC 204 only wish to work on part 1. Part 2 is ISO/TS. Therefore no CEN/ISO parallel work on part 2 (SV on 2005-08-30)

Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 1: Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte (ISO 11135-1:2007)

Dieser Teil von ISO 11135 legt Anforderungen für die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens mit Ethylenoxid für Medizinprodukte fest.
ANMERKUNG 1   Obgleich der Anwendungsbereich dieses Teils von ISO 11135 auf Medizinprodukte begrenzt ist, legt er Anforderungen fest und liefert Anleitungen, die für andere Produkte für die Gesundheitsfürsorge gelten können.
Es sollte nicht vorausgesetzt werden, dass entsprechend den Anforderungen von diesem Teil von ISO 11135 validierte und gelenkte Sterilisationsverfahren bei der Inaktivierung der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt Jakob Krankheit wirksam sind. In bestimmten Ländern sind spezifische Empfehlungen für die Behandlung möglicherweise mit diesen Erregern kontaminierter Materialien erarbeitet worden.
ANMERKUNG 2   Siehe zum Beispiel ISO 22442 1, ISO 22442 2 und ISO 22442 3.
Dieser Teil von ISO 11135 legt keine in den Einzelheiten festgelegte Anforderung zur Bezeichnung eines Medizinprodukts als steril fest.
ANMERKUNG 3   Zu beachten sind nationale oder regionale Anforderungen für die Bezeichnung von Medizinprodukten als „steril“. Siehe zum Beispiel EN 556 1 oder ANSI/AAMI ST67.
Dieser Teil von ISO 11135 legt kein Qualitätsmanagementsystem für die Überwachung aller Stufen der Herstellung von Medizinprodukten fest.
ANMERKUNG 4   Für die Entwicklung, Validierung und Lenkung der Anwendung von Sterilisationsverfahren für Medizin¬produkte ist die effektive Durchführung definierter und dokumentierter Verfahren notwendig. Diese Verfahren sind im Allgemeinen Elemente eines Qualitätsmanagementsystems. Es ist keine Anforderung dieses Teils von ISO 11135, dass während der Herstellung oder Wiederaufbereitung ein vollständiges Qualitätsmanagementsystem vorzuliegen hat, aber die als Minimum erforderlichen Elemente eines Qualitätsmanagementsystems zur Lenkung der Anwendung des Sterilisationsverfahrens werden an geeigneten Stellen i

Stérilisation des produits de santé - Oxyde d'éthylène - Partie 1: Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux (ISO 11135-1:2007)

Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 1. del: Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke (ISO 11135-1:2007)

General Information

• Status: Withdrawn
• Publication Date: 30-Apr-2007
• Withdrawal Date: 15-Jul-2014
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 16-Jul-2014
• 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
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)

Relations

• Replaces: EN 550:1994 - Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11135:2014 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
• Effective Date: 05-Mar-2011

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2007
6WHULOL]DFLMDL]GHONRY]D]GUDYVWYHQRQHJR(WLOHQRNVLGGHO=DKWHYH]DUD]YRM
YDOLGDFLMRLQUXWLQVNRNRQWURORVWHULOL]DFLMVNLKSRVWRSNRY]DPHGLFLQVNH
SULSRPRþNH,62
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
(ISO 11135-1:2007)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 1:
Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines
Sterilisationsverfahrens für Medizinprodukte (ISO 11135-1:2007)
Stérilisation des produits de santé - Oxyde d'éthylene - Partie 1: Exigences de
développement, de validation et contrôle de routine d'un processus de stérilisation pour
des dispositifs médicaux (ISO 11135-1:2007)
Ta slovenski standard je istoveten z: EN ISO 11135-1:2007
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 11135-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2007
ICS 11.080.01 Supersedes EN 550:1994
English Version
Sterilization of health care products - Ethylene oxide - Part 1:
Requirements for development, validation and routine control of
a sterilization process for medical devices (ISO 11135-1:2007)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences de développement, de validation et de Ethylenoxid - Teil 1: Anforderungen an die Entwicklung,
contrôle de routine d'un processus de stérilisation pour des Validierung und Lenkung der Anwendung eines
dispositifs médicaux (ISO 11135-1:2007) Sterilisationsverfahrens für Medizinprodukte (ISO
11135:2007)
This European Standard was approved by CEN on 13 April 2007.
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 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 Management Centre has the same status as the
official versions.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11135-1:2007: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11135-1:2007) 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 November 2007, and conflicting national
standards shall be withdrawn at the latest by May 2010.

This document supersedes EN 550:1994.

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,
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.
Endorsement notice
The text of ISO 11135-1:2007 has been approved by CEN as EN ISO 11135-1:2007 without any
modifications.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC 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 Medical devices.

Once this 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 clauses of this standard given in Table ZA 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 — Correspondence between this European Standard and Directive 93/42/EEC
Medical devices
Clause(s)/Sub- Essential Essential Essential Qualifying
clause(s) of this Requirements Requirements Requirements (ERs) remarks/Notes
EN (ERs) of Directive (ERs) of Directive of Directive
90/385/EEC 93/42/EEC 98/79/EC
In part
4,5,6,7,8,9,10,11,12 7 8.3 B.2.3
In part
4,5,6,7,8,9,10,11,12 8.4 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 11135-1
First edition
2007-05-01
Sterilization of health care products —
Ethylene oxide —
Part 1:
Requirements for development, validation
and routine control of a sterilization
process for medical devices
Stérilisation des produits de santé — Oxyde d'éthylène —
Partie 1: Exigences de développement, de validation et de contrôle de
routine d'un processus de stérilisation pour des dispositifs médicaux

Reference number
ISO 11135-1:2007(E)
©
ISO 2007
ISO 11135-1:2007(E)
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ISO 11135-1:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions. 2
4 Quality management systems . 9
4.1 Documentation. 9
4.2 Management responsibility . 9
4.3 Product realization. 9
4.4 Measurement, analysis and improvement — Control of nonconforming product . 10
5 Sterilizing agent characterization . 10
5.1 Sterilizing agent . 10
5.2 Microbicidal effectiveness . 10
5.3 Material effects. 10
5.4 Environmental considerations . 10
6 Process and equipment characterization . 10
6.1 Process characterization . 10
6.2 Equipment characterization. 11
7 Product definition . 12
7.1 General. 12
7.2 Product safety and performance. 12
7.3 Microbiological quality. 12
7.4 Documentation. 13
8 Process definition. 13
9 Validation. 14
9.1 Installation qualification. 14
9.2 Operational qualification. 14
9.3 Performance qualification. 14
9.4 Varying load configurations . 16
9.5 Review and approval of validation. 16
10 Routine monitoring and control . 18
11 Product release from sterilization. 19
12 Maintaining process effectiveness . 19
12.1 General. 19
12.2 Maintenance of equipment . 19
12.3 Requalification . 19
12.4 Assessment of change. 20
Annex A (normative) Determination of lethal rate of the sterilization process — Biological
indicator/bioburden approach. 21
Annex B (normative) Conservative determination of lethal rate of the sterilization process —
Overkill approach. 23
Annex C (informative) General guidance. 25
Bibliography . 41
...