SIST EN ISO 11140-1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 1. del: Splošne zahteve (ISO 11140-1:2005)Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11140-1:2005)Stérilisation des produits de santé - Indicateurs chimiques - Partie 1: Exigences générales (ISO 11140-1:2005)Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:prEN ISO 11140-1kSIST prEN ISO 11140-1:2009en01-marec-2009kSIST prEN ISO 11140-1:2009SLOVENSKI
STANDARD



kSIST prEN ISO 11140-1:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 11140-1December 2008ICS 11.080.01Will supersede EN ISO 11140-1:2005
English VersionSterilization of health care products - Chemical indicators - Part1: General requirements (ISO 11140-1:2005)Stérilisation des produits de santé - Indicateurs chimiques -Partie 1: Exigences générales (ISO 11140-1:2005)Sterilisation von Produkten für die Gesundheitsfürsorge -Chemische Indikatoren - Teil 1: Allgemeine Anforderungen(ISO 11140-1:2005)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 102.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate 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 languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 11140-1:2008: EkSIST prEN ISO 11140-1:2009



prEN ISO 11140-1:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 11140-1:2009



prEN ISO 11140-1:2008 (E) 3 Foreword The text of ISO 11140-1:2005 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 prEN ISO 11140-1:2008 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 11140-1:2005. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 11140-1:2005 has been approved by CEN as a prEN ISO 11140-1:2008 without any modification. kSIST prEN ISO 11140-1:2009



prEN ISO 11140-1:2008 (E) 4 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC 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 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 on medical devices WARNING – Other requirements and other EU-directives may be applicable to the product(s) falling within the scope of the standard.
Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes4.2 to 4.7 8, 7
5.5 5
5.8 13 [except 13.3 a) and 13.6 q)] The relevant Essential Requirement 13.3 a) is partly addressed. The relevant Essential Requirement 13.6 q) is not addressed in this European Standard 6.1 10.1
8 10.1
kSIST prEN ISO 11140-1:2009



Reference numberISO 11140-1:2005(E)© ISO 2005
INTERNATIONAL STANDARD ISO11140-1Second edition2005-07-15Sterilization of health care products — Chemical indicators — Part 1: General requirements Stérilisation des produits de santé — Indicateurs chimiques — Partie 1: Exigences générales
kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ii © ISO 2005 – All rights reserved
kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) © ISO 2005 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Classification.3 5 General requirements.4 6 Performance requirements.6 7 Test methods.7 8 Additional requirements for process (Class 1) indicators.10 9 Additional requirements for single variable (Class 3) indicators.13 10 Additional requirements for multi-variable (Class 4) indicators.13 11 Additional requirements for steam integrating (Class 5) indicators.14 12 Additional requirements for dry heat integrating (Class 5) indicators.14 13 Additional requirements for ethylene oxide integrating (Class 5) indicators.15 14 Additional requirements for emulating (Class 6) indicators.16 Annex A (informative)
Method for demonstrating shelf life of the product.17 Annex B (informative)
Examples of testing indicators.18 Annex C (informative)
Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in ISO 11138 and microbial inactivation.19 Annex D (informative)
Rationale for the liquid-phase test method for steam-formaldehyde indicators.25 Annex E (informative)
Relationship of indicator components.26 Bibliography.27
kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) iv © ISO 2005 – All rights reserved 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 11140-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. This second edition cancels and replaces the first edition (ISO 11140-1:1995 and ISO 11140-1:1995/Amd.1:1998), which has been technically revised. ISO 11140 consists of the following parts, under the general title Sterilization of health care products — Chemical indicators:  Part 1: General requirements  Part 2: Test equipment and methods  Part 3: Class 2 indicators for steam penetration test sheets  Part 4: Class 2 indicators for steam penetration test packs  Part 5: Class 2 indicators for air removal test sheets and packs NOTE ISO 11140-2 is to be replaced by ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment. kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) © ISO 2005 – All rights reserved vIntroduction This part of ISO 11140 specifies performance requirements and/or test methods for chemical indicators intended for use with sterilization processes employing steam, dry heat, ethylene oxide, γ or β radiation, steam-formaldehyde or vaporized hydrogen peroxide. Additional requirements for indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization) are not specifically provided in this part of ISO 11140, however, the general requirements will apply. The requirements for specific test indicators (e.g. Bowie-Dick test indicators) are covered in other parts of ISO 11140. Standards for sterilizers and for the validation and process control of sterilization, describe performance tests for sterilizers and methods of validation and routine control, respectively. This part of ISO 11140 is intended for manufacturers of chemical indicators and specifies the general requirements for chemical indicators. Subsequent parts of this International Standard specify the particular requirements for chemical indicators for particular applications and for defined tests of particular sterilization processes used in health care, including industry. The use of the indicators specified in this part of ISO 11140 are described in ISO 15882, EN 285, ISO 11135 and ISO 17665. Resistometers (see ISO 18472) are used to characterize the performance of the chemical indicators described in this part of ISO 11140. Resistometers allow for precise variation of the specific test conditions and cycle sequences in order to produce controlled physical studies. Resistometers differ from conventional sterilizers; therefore, if conventional sterilizers are used to attempt to duplicate resistometer conditions, erroneous and/or misleading results may occur.
kSIST prEN ISO 11140-1:2009



kSIST prEN ISO 11140-1:2009



INTERNATIONAL STANDARD ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 1Sterilization of health care products — Chemical indicators — Part 1: General requirements WARNING — The use of this part of ISO 11140 may involve hazardous materials, operations and equipment. This part of ISO 11140 does not purport to address to all the safety problems associated with its use. It is the responsibility of the user of this part of ISO 11140 to establish appropriate safety and health practise and determine the applicability of regulatory limitations prior to use. 1 Scope 1.1 This part of ISO 11140 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 variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism. NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs). 1.2 The requirements and test methods of this part of ISO 11140 apply to all indicators specified in subsequent parts of ISO 11140, unless the requirement is modified or added to by a subsequent part, in which case the requirement of that particular part will apply. Relevant test equipment is described in ISO 18472. NOTE Additional requirements for specific test indicators (Class 2 indicators) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ISO 11138 (all parts), Sterilization of health care products — Biological indicator systems ISO 11607, Packaging for terminally sterilized medical devices ISO 184721), Sterilization of health care products — Biological and chemical indicators — Test equipment
1) To be published. kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) 2 © ISO 2005 – All rights reserved 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 bleed lateral migration of the indicator agent beyond the margins within which the indicator agent was applied 3.2 critical variable parameters identified as being essential to the sterilization process (and requiring monitoring) 3.3 endpoint point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values 3.4 graduated response progressive observable change occurring on exposure to one or more process variables allowing assessment of the level achieved 3.5 indicator combination of the indicator agent and its substrate in the final form in which it is intended to be used (see Annex E) NOTE An indicator system in combination with a specific test load is also termed an indicator. 3.6 indicator agent/indicator reagent active substance(s) or combination of substances (see Annex E) 3.7 indicator system combination of the indicator agent and its substrate subsequently intended to be used in combination with a specific test load 3.8 off-set transfer of indicator agent to a material in intimate contact with the surface of the indicator 3.9 parameter specified value for a process variable 3.10 penetration migration of the indicator agent through the substrate to the surface opposite the one to which the indicator agent was applied 3.11 saturated steam water vapour in a state of equilibrium between condensation and evaporation kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 33.12 stated value SV value or values of a critical variable at which the indicator is designed to reach its endpoint as defined by the manufacturer 3.13 substrate carrier or support material onto which the indicator is applied (see Annex E) 3.14 variable condition within a sterilization process, changes that alter microbicidal effectiveness 3.15 visible change change defined by the manufacturer, which can be seen in the indicator after exposure to one or more critical variables of the process NOTE Visible change is used to describe the response of Class 1 process indicators. 4 Classification 4.1 General In subsequent parts of ISO 11140, indicators are classified by their intended use. The chemical indicators described in this part of ISO 11140 are classified into six groups. The chemical indicators within each of these classifications are further subdivided by the sterilization process for which they are designed to be used. The classification structure used is solely to denote the characteristics and intended use of each type of indicator when used as defined by the manufacturer. This classification has no hierarchical significance. 4.2 Class 1: process indicators Process indicators are intended for use with individual units (e.g. packs, containers) to indicate that the unit has been directly exposed to the sterilization process and to distinguish between processed and unprocessed units. They shall be designed to react to one or more of the critical process variables (see Tables 1 to 6). 4.3 Class 2: indicators for use in specific tests Class 2 indicators are intended for use in specific test procedures as defined in relevant sterilizer/sterilization standards. NOTE
The requirements for specific test indicators (Class 2 indicators) are provided in other parts of ISO 11140. 4.4 Class 3: single variable indicators A single variable indicator shall be designed to react to one of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization process at a stated value (SV) of the chosen variable (see 5.7 and 5.8). 4.5 Class 4: multi-variable indicators A multi-variable indicator shall be designed to react to two or more of the critical variables (see 5.2) and is intended to indicate exposure to a sterilization cycle at SVs of the chosen variables (see 5.7 and 5.8). kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) 4 © ISO 2005 – All rights reserved 4.6 Class 5: integrating indicators Integrating indicators shall be designed to react to all critical variables. The SVs are generated to be equivalent to, or exceed the performance requirements given in the ISO 11138 series for BIs (see Clauses 11, 12 and 13). 4.7 Class 6: emulating indicators Emulating indicators are cycle verification indicators which shall be designed to react to all critical variables for specified sterilization cycles. The SVs are generated from the critical variables of the specified sterilization process. 5 General requirements 5.1 The requirements given in this clause shall apply to all indicators unless specifically excluded or amended in a subsequent clause or part of ISO 11140. 5.2 For the different sterilization processes, the following variables are defined as being critical: • STEAM Time, temperature and water (as delivered by saturated steam) • DRY HEAT Time and temperature • ETHYLENE OXIDE Time, temperature, relative humidity and ethylene oxide (EO) concentration • IRRADIATION Total absorbed dose • STEAM-FORMALDEHYDE Time, temperature, water (as delivered by saturated steam) and formaldehyde concentration • VAPOURIZED Time, temperature, hydrogen peroxide concentration, and, if applicable,
HYDROGEN PEROXIDE plasma 5.3 The manufacturer shall establish, document and maintain a formal quality system to cover all operations required by this part of ISO 11140. NOTE ISO 9001 and ISO 13485 describe requirements for quality systems for design, manufacture and testing. 5.4 Each indicator shall be clearly marked with the type of process for which it is intended to be used (see 5.6 and 5.7), with the the class of indicator (see Clause 4), and for Class 3, 4, 5 and 6 indicators, with the the SVs. Where the size or format of the indicator does not permit this information to be stated in a font of 6 characters per centimetre or larger, the information shall be provided on the label and/or instructions for use. 5.5 The indicator shall comply with the requirements of this part of ISO 11140 for the duration of the shelf life as specified by the manufacturer (see Annex A). kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 55.6 Abbreviated descriptions of the process shall be in accordance with the following symbols:
STEAM  all steam sterilization processes
DRY  all dry heat sterilization processes
EO  all ethylene oxide sterilization processes
IRRAD  all ionizing radiation sterilization processes
FORM  all steam/formaldehyde sterilization processes
VH2O2  all vaporized hydrogen peroxide sterilization processes These descriptions are symbols and should not be translated. 5.7 If the indicator is designed for use in specific sterilization cycles, this information shall be stated or coded on the indicator, e.g.
STEAM 121 °C 15 min
(See 3.12 and 5.6.) 5.8 Each package of indicators or the technical information leaflet supplied with the package shall provide the following information: a) the change that is intended to occur; and for colour change indicators where the colour change cannot be adequately described, samples of the expected colour range for both changed and unchanged indicators; b) the critical variable(s) to which the indicator will respond, and where applicable, their SVs; c) the class (see Clause 4), process (see 5.6) and intended use (see 5.7) for which the indicator is designed; d) the storage conditions, before and after use; e) the expiry date, or the manufacturing date plus shelf life, under the specified storage conditions, expressed in accordance with ISO 8601 (e.g. YYYY-MM); f) a unique code (e.g. lot number) to provide traceability; kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) 6 © ISO 2005 – All rights reserved g) instructions for use essential to ensure proper functioning of the indicator; h) any interfering substances that are likely to be encountered, or conditions that are likely to occur, during the intended use of the indicator and which are known to affect adversely the performance of the indicator; i) any safety precautions required during and/or after use; j) the manufacturer's or supplier's name and address; k) the nature of any change that can occur when completely/incompletely changed indicators are stored according to the manufacturer’s instructions. NOTE National or regional regulations could contain additional or different requirements. 5.9 The manufacturer shall retain documentary evidence that the indicator, when used as intended by the manufacturer, does not release any substance known to be toxic in sufficient quantities to cause either a health hazard, or a hazard to the intended properties of the product being sterilized before, during or after the sterilization process for which it is designated. 6 Performance requirements 6.1 General 6.1.1 The condition of the indicator after exposure to a sterilization process, during which all the variables met or exceeded the specified level to produce a visible change, graduated response or endpoint, shall remain unchanged for a period of not less than six months from the date of use, when stored under the conditions specified by the indicator manufacturer. 6.1.2 Incompletely changed indicators can deteriorate on storage, either returning to the unchanged condition or slowly completing the change reaction. If such deterioration can occur, this information should be stated in the technical information supplied by the manufacturer [see 5.8 k)]. 6.2 Class 1 Indicators 6.2.1 The visible change that occurs after exposure of the indicator shall be clearly observable and shall be either from light to dark, dark to light, or shall be from one colour to a distinctly different colour (see Clause 8). 6.2.2 When printed on to single-use packaging material complying with ISO 11607, the indicator agent shall not bleed or offset to such an extent that it compromises the utility of the indicator or presents a hazard for the use of the packaging material. Penetration shall not occur before, during or after the sterilization process for which it is designed, when tested according to the method given in 7.2 (see also 5.9). 6.3 Class 2 indicators Specific requirements for Class 2 indicators are given in Parts 3, 4 and 5 of ISO 11140. 6.4 Classes 3, 4, 5 and 6 indicators 6.4.1 The endpoint which occurs after exposure of the indicator to the SVs of critical variables shall be clearly observable and shall be either from light to dark, dark to light or shall be from one colour to a distinctly different colour. 6.4.2 The indicator agent shall not off-set or penetrate the substrate to which it is applied, or materials with which it is in contact before, during or after the sterilization process for which it is designed, when tested according to the method given in 7.2 (see also 5.9). kSIST prEN ISO 11140-1:2009



ISO 11140-1:2005(E) © ISO 2005 – All rights reserved 77 Test methods 7.1 General Tests for compliance with the requirements given in Clauses 6 and 7 to 14 of this part of ISO 11140 shall be carried out by exposing the indicators to the conditions specified and using equipment complying with ISO 18472, then examining the indicator for compliance. Specific test methods for irradiation indicators are not given. Performance requirements are given in 8.5. NOTE Test equipment and methods for Class 2 indicators are contained in Parts 3, 4 and 5 of ISO 11140. 7.2 Off-set (transference) Place a second layer of a similar substrate to that of the indicator in intimate contact with the indicator reagent. Process the indicator in the sterilization process, as stated by the indicator manufacturer. Visually inspect the indicator, its substrate and the second layer of substrate, before and after processing, for compliance with 6.2.2 or 6.4.2. 7.3 Procedure — Steam indicators 7.3.1 Load the indicator on to a suitable sample holder. The sample holder shall not affect the performance of the indicator. The sample holder should allow the indicator to be exposed to the test conditions in the manner specified by the indicator manufacturer. Different indicators may require different sample holder designs. Consult the indicator manufacturer for guidance. 7.3.2 Before initiating a test cycle, the inner surface of the resistometer shall be heated to the required temperature. 7.3.3 With the loaded sample holder in the resistometer, carry out the following sequence of operations: a) Evacuate the resistometer to 4,5 kPa ± 0,5 kPa within 2 min [manufacturers of chemical indicators may choose to specify the use of a different depth
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