prEN ISO 11137-3

Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data

Migrated from Progress Sheet (TC Comment) (2000-07-10): WIs 030-033 are the result of the splitting of WI 026 (CC/000327) ++ Please contact T Vyze x 850 when progressing this project though any stage

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects

General Information

• Status: Not Published
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• 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: OSIST prEN ISO 11137-3:2004 - Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data

Relations

• Merged Into: EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
• Effective Date: 08-Mar-2023
• Child: EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

EUROPEAN STANDARD
DRAFT
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2004
ICS
English version
Sterilization of health care products - Radiation - Part 3:
Guidance on dosimetric aspects
Stérilisation des dispostifs médicaux - Irradiation - Partie 3:
Indications pour la dosimétrie
This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 204.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 Management Centre 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, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 11137-3:2004: E
worldwide for CEN national Members.

Foreword
This document (prEN ISO 11137-3:2004) 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 document is currently submitted to the parallel Enquiry.

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).
Endorsement notice
The text of ISO/DIS 11137-3:2004 has been approved by CEN as prEN ISO 11137-3:2004
without any modifications.
DRAFT INTERNATIONAL STANDARD ISO/DIS 11137-3
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2004-04-29 2004-09-29
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Sterilization of health care products — Radiation —
Part 3:
Guidance on dosimetric aspects
Stérilisation des produits de santé — Irradiation —
Partie 3: Guide sur les aspects dosimétriques
ICS 11.080.01
ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject
of interest to European standardization. In accordance with the ISO-lead mode of collaboration as
defined in the Vienna Agreement, consultation on this ISO/DIS has the same effect for CEN
members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a
final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS
vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS 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, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2004

ISO/DIS 11137-3
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ii ISO 2004 – All rights reserved

ISO/DIS 11137-3
Contents
Foreword.iv
Introduction.5
1 Scope .1
2 Normative references.1
3 Terms and definitions .1
4 Measurement of dose.1
5 Selection and calibration of dosimetry systems.2
5.1 General .2
5.2 Selection of dosimetry systems.2
5.3 Calibration of dosimetry system.2
6 Establishing the maximum acceptable dose.2
7 Establishing the sterilization dose .3
8 Installation qualification.4
9 Operational qualification.4
9.1 General .4
9.2 Gamma irradiators.4
9.3 Electron beam irradiators .6
9.4 X-ray irradiators.7
10 Performance qualification .8
11 Routine monitoring and control.9
11.1 General .9
11.2 Frequency of dose measurements .10
Annex A Mathematical modeling .11
A.1 General .11
A.2 Types of models .11
A.2.1 Point Kernel.11
A.2.2 Monte Carlo .11
A.3 Use of models .12
A.3.1 Design of irradiators.12
A.3.2 Operation of gamma and x-ray Irradiators.12
A.3.3 Operation of electron beam irradiators.12
Bibliography.13

ISO/DIS 11137-3
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 11137-3 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 11137 consists of the following parts, under the general title Sterilization of health care products — Radiation:
⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical
devices
⎯ Part 2: Establishing the sterilization dose
⎯ Part 3: Guidance on dosimetric aspects
iv © ISO 2004 – All rights reserved

ISO/DIS 11137-3
Introduction
An integral part of radiation sterilization is the ability to measure dose. The dose is measured during all
stages of development, validation and routine monitoring of the sterilization process. It has to be
demonstrated that dose measurement is traceable to a national or international standard, that the
uncertainty of measurement is known, and that the influence of temperature, humidity and other
environmental factors on dosimeter response is known and taken into account.
Requirements in regard to dosimetry and dose measurement are given in ISO 11137-1 and ISO 11137-2.
This part of ISO 11137 gives guidance to these requirements.
ISO/DIS 11137-3
Sterilization of health care products — Radiation — Part 3:
Guidance on dosimetric aspects
1 Scope
This International Standard gives guidance on the requirements relating to dosimetry and dose measurement in
60 137
ISO 11137 parts 1 and 2. It applies to gamma irradiators using the radionuclides Co and Cs, and to irradiators
using a beam from an electron or x-ray generator.
2 Normative references
The following standards contain provisions, which through reference in this text, constitute provisions of this
International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agre
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