EN ISO 11140-1:2014

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

ISO 11140-1:2014 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2014)

Dieser Teil von ISO 11140 legt allgemeine Anforderungen und Prüfverfahren für Indikatoren fest, die deren Exposition gegenüber Sterilisationsverfahren durch physikalische und/oder chemische Veränderungen von Substanzen sichtbar machen und die verwendet werden, um das Erreichen eines oder mehrerer Verfahrensparameter(s), (der) die für ein Sterilisationsverfahren festgelegt sind (ist), zu überwachen. Sie sind in ihrer Wirkung vom Vorhandensein oder der Abwesenheit eines lebenden Organismus unabhängig.
ANMERKUNG 1 Als biologische Prüfsysteme werden diejenigen Prüfungen angesehen, die für ihre Auswertung vom Nachweis der Lebensfähigkeit eines Organismus abhängig sind. Prüfsysteme dieser Art werden in der Normenreihe ISO 11138 für biologische Indikatoren (BI) behandelt.
Die Anforderungen und Prüfverfahren dieses Teils von ISO 11140 gelten für alle Indikatoren, die in nachfolgenden Teilen von ISO 11140 festgelegt werden, außer wenn die Anforderung in einem nach-folgenden Teil abgeändert oder diesem hinzugefügt wird; in diesem Fall gilt die Anforderung dieses besonderen Teils.
Die einschlägigen Prüfgeräte werden in ISO 18472 beschrieben.
ANMERKUNG 2 Zusätzliche Anforderungen für spezifische Prüfindikatoren/Indikatorsysteme (Indikatoren des Typs 2) sind in ISO 11140-3, ISO 11140-4 und ISO 11140-5 angegeben.

Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (ISO 11140-1:2014)

L'ISO 11140-1:2014 spécifie les exigences générales et les méthodes d'essai relatives aux indicateurs qui révèlent l'exposition à des procédés de stérilisation par modification physique et/ou chimique de substances, et qui sont utilisés pour contrôler l'obtention d'un ou de plusieurs paramètres spécifiés pour un procédé de stérilisation. Leur action ne dépend pas de la présence ou de l'absence d'un organisme vivant.

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2014)

Ta del standarda ISO 11140 določa splošne zahteve in preskusne metode za indikatorje, ki kažejo izpostavljenost sterilizacijskim postopkom s fizično in/ali kemično spremembo snovi ter se uporabljajo za spremljanje doseganja parametra(-ov) postopka za sterilizacijski postopek. Njihovo delovanje ni odvisno prisotnosti ali odsotnosti živega organizma.
OPOMBA 1 Biološki preskuševalni sistemi se obravnavajo kot sistemi, katerih interpretacija je odvisna od sposobnosti organizma za življenje. Preskuševalni sistemi te vrste so obravnavani v standardih ISO 11138 za biološke indikatorje (BI).
Zahteve in preskusne metode iz tega dela standarda ISO 11140 veljajo za vse indikatorje, določene v
nadaljnjih delih standarda ISO 11140, razen če je zahteva v enem od nadaljnjih delov spremenjena ali dodana, pri čemer v takem primeru velja zahteva iz zadevnega dela.
Zadevna preskusna oprema je opisana v standardu ISO 18472.
OPOMBA 2 Dodatne zahteve za posebne preskusne indikatorje/sisteme indikatorjev (indikatorji vrste 2) so navedene v standardih ISO 11140-3, ISO 11140-4 in ISO 11140-5.

General Information

• Status: Published
• Publication Date: 11-Nov-2014
• Withdrawal Date: 30-May-2015
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 7 - Biological and chemical indicators
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 12-Nov-2014
• Completion Date: 12-Nov-2014
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to 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 11140-1:2015 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)

Relations

• Replaces: EN ISO 11140-1:2009 - Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
• Effective Date: 13-Nov-2010

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2015
1DGRPHãþD
SIST EN ISO 11140-1:2009
Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne
zahteve (ISO 11140-1:2014)
Sterilization of health care products - Chemical indicators - Part 1: General requirements
(ISO 11140-1:2014)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11140-1:2014)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences
générales (ISO 11140-1:2014)
Ta slovenski standard je istoveten z: EN ISO 11140-1:2014
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 11140-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2014
ICS 11.080.01 Supersedes EN ISO 11140-1:2009
English Version
Sterilization of health care products - Chemical indicators - Part
1: General requirements (ISO 11140-1:2014)
Stérilisation des produits de santé - Indicateurs chimiques - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 1: Exigences générales (ISO 11140-1:2014) Chemische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11140-1:2014)
This European Standard was approved by CEN on 23 August 2014.

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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-1:2014 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 93/42/EC on medical devices .4

Foreword
This document (EN ISO 11140-1:2014) has been prepared by Technical Committee ISO/TC 198 "Sterilization
of health care products" in collaboration with Technical Committee CEN/TC 102 “Sterilizers for medical
purposes” the secretariat of which is held by DIN.
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 May 2015, and conflicting national standards shall be withdrawn at the
latest by May 2015.
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 supersedes EN ISO 11140-1:2009.
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, 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 11140-1:2014 has been approved by CEN as EN ISO 11140-1:2014 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC 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/EC 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 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 93/42/EC
on medical devices
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
prEN ISO 11140-1 of Directive 93/42/EC
7.2
5.9 release of toxic substances
6.2.2 transfer type 1
6.4.2 transfer type. 3 – 6
7.2 test procedure
st
5.8 g) 7.3, 1 part Interfering substances
5.8 h) Safety precautions required
during and/or after use
6.2.2 Bleed and offset
4.1; 4.2; 5; 6.1; 6.2; 7; 8 8.7 type 1 indicator
5.8 13.1 Instructions for use
5.6, 5.7 13.2 Symbols
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 a), b) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 c) Labelling
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 d) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 e), f), g), h) Labelling, expiry date.
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
prEN ISO 11140-1 of Directive 93/42/EC
5.8 e) 13.3 i) Storage
5.8 g) Interfering substances
5.8 13.3 j) Instructions for use
5.8 h) 13.3 k) Safety precautions
5.4, 5.6, 5.7, 5.8 i), 5.8 k) 13.3 l) Labelling
4 Classification of indicators
5.2 Critical variables and stated
values
5.8 j) 13.3 m), n) Labelling
5.4 13.4 Marking
5.8 13.6 a) Marking
5.8 13.6 b) Marking
5.8 h) 13.6 e) Instructions after use
5.9 Toxicity declaration
5.8 g) 13.6 f) Interfering substances
5.8 h) 13.6 g), h), j), k), l), m), n), o), p) Instructions after use
5.9 Toxicity declaration
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 11140-1
Third edition
2014-11-01
Sterilization of health care products —
Chemical indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 1: Exigences générales
Reference number
ISO 11140-1:2014(E)
©
ISO 2014
ISO 11140-1:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11140-1:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Categorization . 4
4.1 General . 4
4.2 Type 1: process indicators . 4
4.3 Type 2: indicators for use in specific tests . 5
4.4 Type 3: single critical process variable indicators . 5
4.5 Type 4: multicritical process variable indicators . 5
4.6 Type 5: integrating indicators . 5
4.7 Type 6: emulating indicators . 5
5 General requirements . 5
6 Performance requirements . 8
6.1 General . 8
6.2 Type 1 indicators. 9
6.3 Type 2 indicators. 9
6.4 Types 3, 4, 5 and 6 indicators . 9
7 Test methods . 9
7.1 General . 9
7.2 Off-set (transference) . 9
7.3 Procedure — Steam indicators . 9
7.4 Procedure — Dry heat indicators .10
7.5 Procedure — EO indicators .10
7.6 Procedure — Low temperature steam and formaldehyde indicators.11
7.7 Procedure — Vaporized hydrogen peroxide indicators .11
8 Additional requirements for process (Type 1) indicators .12
8.1 Process indicators printed or applied on to packaging material .
...