EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

ISO 11737-1:2006 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable micro-organisms on or in a medical device, component, raw material or package.

Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten (ISO 11737-1:2006)

Dieser Teil von ISO 11737 legt Anforderungen für die Zählung und mikrobiologische Charakterisierung der Population lebensfähiger Mikroorganismen auf oder in einem Medizinprodukt, Bauteil, Rohstoff oder einer Verpackung fest und liefert dazu eine Anleitung.
ANMERKUNG 1   Art und Umfang der mikrobiologischen Charakterisierung hängen von der vorgesehenen Verwendung der Daten über die Keimbelastung ab.
Dieser Teil von ISO 11737 legt keine Anforderungen für die Zählung oder Identifizierung kontaminierender Viren oder Protozoen fest.
ANMERKUNG 2   Weiterhin beziehen sich die in dieser Norm festgelegten Anforderungen nicht auf Entnahme und Nachweis der Erreger spongiformer Enzephalopathien wie Scrapie, bovine spongiforme Enzephalopathie und Creutzfeldt-Jakob-Krankheit.
Dieser Teil von ISO 11737 legt keine Anforderungen an die mikrobiologische Überwachung der Umgebung fest, in der Medizinprodukte hergestellt werden.

Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 1: Détermination d'une population de micro-organismes sur des produits (ISO 11737-1:2006)

L'ISO 11737-1:2006 spécifie les exigences et fournit les directives pour le dénombrement et la caractérisation microbienne de la population de micro-organismes viables sur ou dans un dispositif médical, un composant, une matière première ou un emballage.

Sterilizacija medicinskih pripomočkov - Mikrobiološke metode - 1. del: Določevanje populacije mikroorganizmov na izdelku (ISO 11737-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2006
• Withdrawal Date: 30-Jan-2018
• ICS: 07.100.10 - Medical microbiology
• 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: 31-Jan-2018
• 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 11737-1:2006 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)

Relations

• Replaces: EN 1174-1:1996 - Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1: Requirements
• Effective Date: 22-Dec-2008
• Replaces: EN 1174-3:1996 - Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3: Guide to the methods for validation of microbiological techniques
• Effective Date: 22-Dec-2008
• Replaces: EN 1174-2:1996 - Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2: Guidance
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11737-1:2018 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
• Effective Date: 13-May-2014
• Corrected By: EN ISO 11737-1:2006/AC:2009 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006/Cor 1:2007)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN 1174-1:2000
SIST EN 1174-2:2000
SIST EN 1174-3:2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY0LNURELRORãNHPHWRGHGHO
'RORþHYDQMHSRSXODFLMHPLNURRUJDQL]PRYQDL]GHONX,62
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a
population of microorganisms on products (ISO 11737-1:2006)
Sterilisation von Medizinprodukten - Mikrobiologische Verfahren - Teil 1: Bestimmung der
Population von Mikroorganismen auf Produkten (ISO 11737-1:2006)
Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 1:
Détermination d'une population de micro-organismes sur des produits (ISO 11737-
1:2006)
Ta slovenski standard je istoveten z: EN ISO 11737-1:2006
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
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 11737-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 07.100.10; 11.080.01 Supersedes EN 1174-1:1996, EN 1174-2:1996,
EN 1174-3:1996
English Version
Sterilization of medical devices - Microbiological methods - Part
1: Determination of a population of microorganisms on products
(ISO 11737-1:2006)
Stérilisation des dispositifs médicaux - Méthodes Sterilisation von Medizinprodukten - Mikrobiologische
microbiologiques - Partie 1: Détermination d'une population Verfahren - Teil 1: Bestimmung der Population von
de micro-organismes sur des produits (ISO 11737-1:2006) Mikroorganismen auf Produkten (ISO 11737-1:2006)
This European Standard was approved by CEN on 23 March 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 11737-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11737-1:2006) 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 October 2006, and conflicting national standards
shall be withdrawn at the latest by October 2006.

This document supersedes EN 1174-1:1996, EN 1174-2:1996 and EN 1174-3:1996.

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 11737-1:2006 has been approved by CEN as EN ISO 11737-1:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directives 90/385/EEC concerning active
implantable medical devices, 93/42/EEC concerning medical devices
and 98/79/EC concerning 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 one means of conforming to
Essential Requirements of the New Approach Directives 90/385/EEC concerning active
implantable medical devices, 93/42/EEC concerning medical devices and 98/79/EC concerning in
vitro diagnostic medical devices.

Once this standard is cited in the Official Journal of the European Communities under thos
Directives and has been implemented as a national standard in at least one Member State,
compliance with the normative 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 those Directives and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directives 90/385 EEC
concerning active implantable medical devices, 93/42/EEC concerning medical devices and
98/79/EC concerning in vitro diagnostic medical devices

Clause(s)/Sub- Essential Essential Essential Qualifying
clause(s) of this Requirements Requirements Requirements remarks/Notes
European Standard (ERs) of Directive (ERs) of (ERs) of Directive
90/385/EEC Directive 98/79/EC
93/42/EEC
In part
4, 5, 6, 7, 8, 9, 10, 11, 7 8.3 2.3
In part
4, 5, 6, 7, 8, 9, 10, 11, 8.4 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 11737-1
Second edition
2006-04-01
Sterilization of medical devices —
Microbiological methods —
Part 1:
Determination of a population of
microorganisms on products
Stérilisation des dispositifs médicaux — Méthodes microbiologiques —
Partie 1: Détermination d'une population de micro-organismes sur des
produits
Reference number
ISO 11737-1:2006(E)
©
ISO 2006
ISO 11737-1:2006(E)
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ISO 11737-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Quality management system elements .4
4.1 Documentation. 4
4.2 Management responsibility . 4
4.3 Product realization. 4
4.4 Measurement, analysis and improvement — Control of nonconforming product . 5
5 Selection of product . 5
5.1 General. 5
5.2 Sample item portion (SIP) . 5
6 Methods of determination and microbial characterization of bioburden . 6
6.1 Determination of bioburden. 6
6.2 Microbial characterization of bioburden . 7
7 Validation of method for determining bioburden . 7
8 Routine determination of bioburden and interpretation of data. 7
9 Maintenance of the method of determination of bioburden. 8
9.1 Changes to the product and/or manufacturing process . 8
9.2 Changes to the method of determination of bioburden . 8
9.3 Revalidation of the method of determination of bioburden . 8
Annex A (informative) Guidance on determination of a population of microorganisms on product. 9
Annex B (informative) Guidance on methods of determination of bioburden. 22
Annex C (informative) Validation of bioburden methods. 31
Bibliography . 34

ISO 11737-1:2006(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11737-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11737-1:1995) which has been technically
revised and ISO 11737-3:2004 whose contents it now incorporates.
ISO 11737 consists of the following parts, under the general title Sterilization of medical devices —
Microbiological methods:
⎯ Part 1: Determination of a population of microorganisms on products
⎯ Part 2: Tests of sterility performed in the validation of a sterilization process
iv © ISO 2006 – All rights reserved

ISO 11737-1:2006(E)
Introduction
A sterile medical device is one that is free of viable microorganisms. International standards that specify
requirements for validation and routine control of sterilization processes, require, when it is necessary to
supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to
sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in
accordance with the requirements
...