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BRITISH STANDARDBS EN867-5:2001Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type SThe European Standard EN 867-5:2001 has the status of aBritish StandardICS 11.080.10; 19.100NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 867-5:2001National forewordThis British Standard is the official English language version ofEN 867-5:2001.The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/3, Sterilization indicators, which has the responsibility to:aid enquirers to understand the text;present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;monitor related international and European developments and promulgate them in the UK.A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue.A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application.Compliance with a British Standard does not of itself confer immunity from legal obligations.This British Standard, having been prepared under the direction of the Sector Policy and Strategy Committee for Materials and Chemicals, was published under the authority of the Standards Policy and Strategy Committee on18 October 2001 BSI 18 October 2001ISBN 0 580 38542 6Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page,pages 2 to 24, an inside back cover and a back cover.The BSI copyright date displayed in this document indicates when the document was last issued.Amd. No.DateCommentsAmendments issued since publicationEUROPEAN STANDARD NORME EUROPENNEEUROPISCHE NORMEN 867-5August 2001ICS 11.080.10English versionNon-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type SSystmes non biologiques destins tre utiliss dans des strilisateurs - Partie 5: Spcifications des systmes indicateurs et dispositifs dpreuve de procd destins tre utiliss pour les essais de performances relatifs aux petits strilisateurs de Type B et de Type SNichtbiologische Systeme fr den Gebrauch in Sterilisatoren - Teil 5: Festlegungen von Indikatorsystemen und Prfkrpern fr die Leistungsprfung von Klein- Sterilisatoren vom Typ B und vom Typ SThis European Standard was approved by CEN on 25 July 2001.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 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 Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATION C O M I T EUR O P EN DE NOR M A L I S A TI ON EUR O P I S C H ES KOM I TEE F R NOR M UNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN 867-5:2001 EEN 867-5:2001 (E)ContentspageForeword. 3Introduction . 41 Scope . 42 Normative references . 53 Terms and definitions . 54 Requirements . 65 Test methods. 126 Marking, labelling and packaging. 16Annex A (normative) Small steam exposure apparatus and steam for test purposes. 17Annex B (normative) Test cycles for evaluation of indicator performance in the porous load process challenge devices. 19Annex C (normative) Test cycles for evaluation of indicator systems for use in hollow load process challenge devices. 22Annex D (normative) Test cycles for evaluation of indicator systems for use in hollow load process challenge devices. 23Bibliography . 2423ForewordThis European Standard has been prepared by 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 February 2002, and conflicting national standards shall be withdrawn at the latest by February 2002.This European Standard has been considered by CEN/TC 102 as one of a series of European Standards concerned with non-biological indicators used in the testing, monitoring and routine operation of sterilizers. These standards are:EN 867-1Non-biological systems for use in sterilizers Part 1: General requirementsEN 867-2Non-biological systems for use in sterilizers Part 2: Process indicators (Class A)EN 867-3Non-biological systems for use in sterilizers Part 3: Specification for Class B indicators for use in the Bowie and Dick testEN 867-4Non-biological systems for use in sterilizers Part 4: Specification for indicators as an alternative to the Bowie and Dick test for the detection of steam penetrationprEN 867-5Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type SIn addition CEN/TC 102 Working Group 7 has prepared a series of European Standards describing biological indicators for use in sterilizers. These European Standards are:EN 866-1Biological systems for testing sterilizers and sterilization processes Part 1: General require- mentsEN 866-2Biological systems for testing sterilizers and sterilization processes Part 2: Particular systems for use in ethylene oxide sterilizersEN 866-3Biological systems for testing sterilizers and sterilization processes Part 3: Particular systems for use in moist heat sterilizersEN 866-4Biological systems for testing sterilizers and sterilization processes Part 4: Particular systems for use in irradiation sterilizersEN 866-5Biological systems for testing sterilizers and sterilization processes Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizersEN 866-6Biological systems for testing sterilizers and sterilization processes Part 6: Particular systems for use in dry heat sterilizersEN 866-7Biological systems for testing sterilizers and sterilization processes Part 7: Particular requirements for self-contained biological indicator systems for use in moist heat sterilizersEN 866-8Biological systems for testing sterilizers and sterilization processes Part 8: Particular require- ments for self-contained biological indicator systems for use in ethylene oxide sterilizersThe annexes A, B, C and D are normative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.EN 867-5:2001 (E)IntroductionThe indicators and process challenge devices described in this European Standard are intended specifically for use in carrying out tests on small steam sterilizers, Type B or Type S.prEN 13060 Parts 2 and 4 specify requirements and tests for small steam sterilizers Type B which are intended to process solid products, hollow products, and porous products any of which may be wrapped in one or more layers of sterilization grade packaging materials (see EN 868) and for small steam sterilizers Type S which may also be specified by the manufacturer of the small steam sterilizer as intended to process hollow products and/or porous products.Small sterilizers unable to accommodate a sterilization module (600 mm x 300 mm x 300 mm) cannot be tested using the tests described in EN 285:1996 for large sterilizers for wrapped goods and porous loads either because the chamber size is unable to accommodate the standard test packs or because the efficacy of the tests is impaired when the test pack occupies a large proportion of the chamber volume.The indicator systems described in this European Standard are intended to be used, in conjunction with the appropriate process challenge device, to demonstrate the rapid and complete penetration of steam into the process challenge device. The construction of the process challenge device and the performance of the indicator are designed to ensure that penetration of steam in the load within the sterilizer will provide adequate assurance that steam penetration will occur in routine loads.1 ScopeThis European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B or Type S where appropriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5 l.Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped.The relevant section of this European Standard on porous loads specifies the requirements for: a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers; an indicator system for use in the porous load process challenge device. An indicator for this purpose is a ClassB indicator as described in EN 867-1. an indicator employing an alternative process challenge device equivalent to the porous load process challenge device.The relevant section of this European Standard on hollow instruments specifies the requirements for: hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-4; an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN 867-1.The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the process challenge device with no part of the process challenge device closer than 20 mm from the vessel wall; in the case of the porous load process challenge device the total internal volume of the vessel is not less than 10 l.2 Normative referencesThis European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated references subsequent amendments to, or revisions of, any of these publications apply to this European Standard only when incorporated into it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments).EN 285:1996Sterilization Steam sterilizers Large sterilizers.EN 866-3Biological systems for testing sterilizers and sterilization processes Part 3: Particular systems for use in moist heat sterilizers.EN 867-1Non-biological systems for use in sterilizers Part 1: General requirements.EN 867-3:1997Non-biological indicator systems for use in sterilizers Part 3: Specification for Class B indicators for use in theBowie and Dick test.EN 867-4Non-biological systems for use in sterilizers Part 4: Specification for indicators as an alternative to the Bowie andDick test for the detection of steam penetration.prEN 13060-2Small steam sterilizers Part 2: Particular requirements and test methods for type B sterilizers, intended for the sterilization of wrapped solid, hollow and porous products.prEN 13060-4Small steam sterilizers Part 4: Particular requirements and test methods for type S sterilizers, intended for the sterilization of products specified by the manufacturer of the sterilizer.EN 20187Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990).EN 20534Paper and board Determination of thickness and apparent bulk density or apparent sheet density(ISO 534:1988).EN ISO 3696:1995Water for analytical laboratory use Specification and test methods (ISO 3696:1987).EN ISO 5457:1999Technical product documentation Sizes and layout of drawing sheets (ISO 5457:1999).ISO 10012-1Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment.3 Terms and definitionsFor the purposes of this European Standard, the definitions given in EN 867-1 and the following definitions apply:3.1hollow loaddevices having a minimum diameter of 2 mm or greater and no point internally at a distance greater than 1500 timesthe minimum internal diameter from direct open connection with the surrounding environment3.2process challenge deviceobject which simulates the worst case of conditions for attainment of the specified sterilization conditions within theitems to be sterilizedNOTE The device is so constructed that a biological or non-biological indicator system can be placed within the device in the position which it is most difficult for the sterilizing agent to reach. The design of the process challenge device depends on the nature of the goods to be sterilized and the sterilization procedure.3.3total internal volumevolume of water at 20 C which would be required to fill the hollow load process challenge device, including the spacewhich would, in use, be occupied by the indicator system3.4free capsule volumecapsule volume excluding the volume occupied by the indicator system3.5indicator system volumevolume of water at 20 C which would fill a space bounded by the maximum external dimensions of the indicatorsystem3.6capsule volumeinternal volume of that part of the hollow load process challenge device intended to accommodate the indicator systemdetermined as the volume of water at 20 C which would be required to fill the capsule4 Requirements4.1 General4.1.1 The requirements of EN 867-1 shall apply.4.1.2 Samples of non-biological indicators shall be conditioned in accordance with EN 20187 prior to testing for performance.4.1.3 The combination of process challenge device and indicator system shall be specified as providing a test system for either a porous load (see 4.2, 4.3 and 4.4) or a hollow instrument load (see 4.5 and 4.6).4.1.4 When used in accordance with the manufacturers instructions the indicator system, in combination with any specified process challenge device, shall provide indication of failure to attain steam penetration with a sensitivity sufficient to ensure that a satisfactory result will give confirmation that steam penetration would be attained in a sterilizer load of the type specified.4.1.5 Indicator systems intended for use with re-usable user-assembled process challenge devices shall not visibly transfer indicator reagent to the material of the process challenge device during processing.Pre-assembled process challenge devices and indicator systems intended for use with the single-use user-assembled process challenge devices shall not transfer indicator reagent to the material of the process challenge device during processing to an extent which impairs the utility of the product.Compliance shall be demonstrated by visual examination after testing in accordance with the requirements of 4.3.3 and 5.3.2 as appropriate.EN 867-5:2001 (E)4.2 Process challenge device for porous load4.2.1 The process challenge device for porous loads shall be a standardised test pack for assessing the performance in the sterilization of porous loads in small steam sterilizers.4.2.2 The pack shall be constructed from plain cotton sheets, bleached to a good white and each having an approximate size of 450 mm x 300 mm. Edges other than selvage shall be oversewn, not hemmed.4.2.3 The number of th
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