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Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI BRITISH STANDARD Packaging materials and systems for medical devices which are to be sterilized Part General requirements and test methods The European Standard EN 868-1 : 1997 has the status of a British Standard ICS 11.080; 55.040 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BS EN 868-1 : 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI BS EN 868-1 : 1997 National foreword This British Standard is the English language version of EN 868-1 : 1997 The UK participation in its preparation was entrusted by Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors, to Subcommittee LBI/35/9, Sterilization packaging materials, 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 committee can be obtained on request to its secretary Cross-references The 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 Attention is also drawn to current British Standards BS 6254 : 1989, BS 6255 : 1989, BS 6256 : 1989, BS 6257 : 1997 and BS 6871 : 1989 Further Parts of EN 868 corresponding to these standards are in preparation On publication of the corresponding Parts of BS EN 868, the current British Standards will be withdrawn Sterilization packaging materials falling within the scope of this standard are considered to be medical devices under Directive 93/42/EEC and compliance with the requirements of the standard is a means of ensuring that particular essential requirements of the Directive are met (see annex ZA of the standard) Subsequent Parts of EN 868 may be used to demonstrate compliance with some of the requirements of Part However, compliance with a subsequent Part of EN 868 alone may not necessarily be considered to ensure that the essential requirements of the Directive have been met The subsequent Parts of EN 868 deal with a number of specific and commonly used materials These materials are not a comprehensive list of those which may be used to achieve compliance with the requirements of Part Compliance with a British Standard does not of itself confer immunity from legal obligations Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages to 16, an inside back cover and a back cover This British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 December 1997 BSI 1997 ISBN 580 27683 X Amendments issued since publication Amd No Date Text affected Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI EN 868-1 EUROPEAN STANDARD NORME EUROPEÂENNE EUROPAÈISCHE NORM February 1997 ICS 11.080; 55.040 Descriptors: Medical equipment, sterilization, packing, specifications, operating requirements, compatibility, storage English version Packaging materials and systems for medical devices which are to be sterilized Ð Part 1: General requirements and test methods MateÂriaux et systeÁmes d'emballages pour les dispositifs meÂdicaux devant eÃtre steÂriliseÂs Ð Partie 1: Exigences geÂneÂrales et meÂthodes d'essai Verpackungsmaterialien und -systeme fuÈr zu sterilisierende Medizinprodukte Ð Teil 1: Allgemeine Anforderungen und PruÈfverfahren This European Standard was approved by CEN on 1997-01-27 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom CEN European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN Ð All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 868-1 : 1997 E Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 Foreword prEN 868-4 This 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 August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997 This European Standard 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 standard According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom This standard is the first of a series of draft European Standards concerned with packaging materials and systems for medical devices which are to be sterilized These other draft European Standards currently are: prEN 868-2 prEN 868-3 Packaging materials and systems for medical devices which are to be sterilized Ð Part 2: Sterilization wrap Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 3: Paper for use in the manufacture of paper bags (specified in Part of this standard) and in the manufacture of pouches and reels (specified in Part of this standard) Ð Requirements and test methods prEN 868-5 prEN 868-6 prEN 868-7 prEN 868-8 Packaging materials and systems for medical devices which are to be sterilized Ð Part 4: Paper bags Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 5: Heat sealable pouches and reel material manufactured from paper and plastic Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 8: Re-usable containers for steam sterilizers conforming to prEN 285 Ð Requirements and test methods BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 Contents Foreword Introduction Scope Normative references Definitions Requirements Test methods Documentation Information Annex A (informative) Guidance on clause `Requirements' Annex B (informative) Microbial barrier evaluation scheme (see 4.6) Annex C (informative) Air impermeability Ð Test methods Annex D (informative) Microbial barrier properties Ð Test methods for materials Annex E (informative) Microbial barrier properties Ð Test methods for permeable closures (filter assembly, tortuous path) Annex F (informative) Impermeability and continuity of seals formed by fusion or adhesion Ð Test methods Annex G (informative) Impermeability of seals not formed by fusion or adhesion Ð Test methods Ð Test procedure for rigid containers Annex H (informative) Bibliography Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provision of EU Directives BSI 1997 Page 4 4 7 11 11 ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 11 12 12 14 15 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 Introduction Normative references This standard specifies general requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging Subsequent standards in this series (prEN 868-2 et sequence) specify particular requirements for a range of commonly used packaging materials and systems It is intended that compliance with one of the subsequent particular standards can be used to demonstrate conformance with one or more of the requirements of this Part (general requirements) as specified in the particular standard The adequacy of a packaging system depends additionally on the manner in which each unit is closed or sealed Attention is drawn to the need to validate and monitor the packaging process (see also European Standards on quality systems and ISO 11607) This 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 in it by amendment or revision For undated references the latest edition of the publication referred to applies Scope 1.1 This European Standard specifies the requirements and test methods for packaging materials and systems: ± which are used for packaging of medical devices which are to be terminally sterilized; and ± which are intended to maintain sterility of the device NOTE This standard has been developed as a means to show compliance with relevant European Directives If health care facilities e.g hospitals not place medical devices on the market, they are not covered by these Directives Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard NOTE Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard 1.2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture NOTE Attention is drawn to the standards for quality systems (see e.g EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied EN 550 Sterilization of medical devices Ð Validation and routine control of ethylene oxide sterilization EN 552 Sterilization of medical devices Ð Validation and routine control of sterilization by irradiation EN 554 Sterilization of medical devices Ð Validation and routine control of sterilization by moist heat EN 20187 Paper, board and pulps Ð Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187 : 1990) ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ Definitions For the purposes of this European Standard, the following definitions apply 3.1 bioburden Population of viable micro-organisms on an item 3.2 closure Means used to close a package where no seal is formed; e.g by repeated folding to construct a tortuous path 3.3 closure integrity Characteristics of the closure which ensures that it presents a microbial barrier 3.4 final pack Pack in which a medical device is sterilized NOTE In addition to the primary pack a secondary and/or transport pack can be included 3.5 microbial barrier Ability to prevent the ingress of micro-organisms 3.6 packaging material Any material used in the fabrication or sealing of a packaging system or primary pack BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 3.7 packaging system One or more packaging materials assembled into a single unit intended as part or all of a primary pack 3.8 primary pack Sealed or closed packaging system which forms a microbial barrier, enclosing a medical device 3.9 seal Result of joining of surfaces together NOTE For example by use of adhesives, thermal fusion or gaskets 3.10 seal integrity Characteristics of the seal which ensures that it presents a microbial barrier 3.11 secondary pack Pack containing one or more medical devices, each in its primary pack 3.12 sterile Condition of a medical device that is free from viable micro-organisms (EN 556) 3.13 terminally sterilized Term for medical devices which are sterilized after being completely sealed or enclosed in at least the primary pack 4.1.2 Raw materials used for the manufacture of packaging materials may be virgin or reclaimed materials, provided that the source, history and traceability of all raw materials, especially recycled materials, shall be known and controlled to ensure that the finished product will consistently meet the requirements of this standard NOTE With current commercial technologies, it is unlikely that reclaimed material other than manufacturing waste will be sufficiently controlled to allow its safe use for medical device packaging 4.2 Sterilization process compatibility of packaging materials and systems 4.2.1 Sterilization process specified It shall be demonstrated and documented that the packaging material and/or system is suitable for use in the sterilization process for which it is intended by the manufacturer of the packaging material and/or system This shall include a demonstration that packaging materials and/or systems have, when necessary, sufficient permeance to air and the sterilant in order to permit the attainment of the required conditions for sterilization and to permit removal of sterilant after sterilization when assembled into a specified form for loading into the sterilizer ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ 3.14 transport pack Pack containing one or more primary and/or secondary packs intended to provide the necessary protection during transport and storage Requirements NOTE Guidance on the interpretation of these requirements is given in annex A 4.1 General 4.1.1 The conditions under which the packaging material and/or system is produced, stored, transported and handled shall be established, controlled and documented, if applicable, in order to ensure that: ± the conditions are compatible with the use for which the packaging material and/or system is designed; and ± the performance characteristics of the packaging material and/or system is maintained As a minimum, the following shall be considered for all packaging materials and/or systems: ± temperature range; ± pressure range; ± humidity range; ± maximum rate of change of the above, where necessary; ± exposure to sunlight or UV light; ± cleanliness; ± bioburden NOTE The bioburden of the packaging material and/or system should be considered when determining the sterilization process parameters BSI 1997 NOTE It is recommended to use a sterilizer designed, constructed and operating within the requirements of the relevant European Standards e.g EN 285 and prEN 1422 4.2.2 Sterilization process not specified and/or sterilization process not covered by European Standards When the packaging material and/or system is not specified as intended for the sterilization process which will be used or the sterilization process is one for which there is no applicable harmonized standard, the suitability of the packaging material and/or system for the sterilization process shall be established This shall be done by validation of the final pack in the sterilization process in accordance with EN 550, EN 552 and EN 554 or other methods of demonstrated equivalence NOTE For sterilization processes not covered by EN 550, EN 552 or EN 554, the validation should include determination that the final pack is sufficiently permeable to all physical and chemical agents which affect the efficacy of the sterilization process 4.3 Design 4.3.1 General requirements The packaging material and/or system shall be designed to minimize the safety hazard to user or patient under the intended specified use The design of the final pack shall include consideration of at least the following: ± the compatibility of the packaging material and/or system with the medical device i.e that the packaging has no adverse effect on the medical device and vice-versa (see 4.3.2); ± the compatibility of the packaging material and/or system with the sterilization process (see 4.2); Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 ± the compatibility of the packaging material and/or system with the labelling system (see 4.3.3.); ± the physical, chemical and microbial protection provided by the packaging material and/or system; ± the compatibility of the packaging material and/or system with the users requirements at the point of use e.g aseptic opening 4.3.2 Compatibility with the medical device The suitability of the packaging material and/or system for use with the particular medical device shall be determined This shall include limiting values for physical characteristics of both the medical device as well as the stresses which will be imposed during sterilization and subsequent transport and storage Factors to be considered shall include: ± the mass and configuration of the medical device to be packed; ± the presence of sharp edges or protrusions; ± the need for physical and other protection; ± the sensitivity of the medical device to particular risks e.g radiation, moisture, mechanical shock, static discharge NOTE Documented historical evidence can be used for packaging materials and/or systems which have previously been used satisfactorily 4.3.3 Compatibility with the labelling system The labelling system shall: ± not adversely affect the compatibility of the packaging material and/or system with the sterilization process to be used; ± not be rendered illegible by the sterilization process to be used; ± not be printed or written in ink of a type which may be transferred to the medical device nor react with the packaging material and/or system to impair the utility of the packaging material and/or system nor change colour to an extent which renders the label illegible For labels fixed to the surface of the packaging material and/or system the attachment system shall withstand exposure to the sterilization process and the manufacturer's defined storage and transport conditions NOTE Labelling can take a number of forms, e.g.: ± labelling printed or written directly on the packaging material and/or system; ± labels consisting of another layer of material attached to the surface of the packaging material and/or system by adhesive, fusion etc 4.4 Toxicity Packaging materials and/or systems shall not release material known to be toxic in sufficient quantity to cause a health hazard either before, during or after sterilization under the conditions of use 4.5 Biocompatibility If necessary, the biocompatibility of the packaging materials and/or systems shall be assessed with regard to the intended use of the medical device NOTE For selection of test methods for biocompatibility see prEN ISO 10993-1 4.6 Sterility maintenance The packaging materials and/or systems assembled in the form in which they will be presented to the sterilizers, when assembled, stored, transported and used in accordance with the manufacturer's instructions, shall maintain the sterility of the contents from the time at which they are rendered sterile to the expiry date specified or to the point of use This shall be demonstrated by testing microbial barrier properties In the absence of an applicable standardized final pack test method, verification of microbial barrier performance characteristics can be obtained by reference to subsidiary particular requirements for single components of the primary pack for which compliance can be more readily demonstrated These tests shall be carried out on the packaging material, or combination of packaging materials, in the form in which they are intended to constitute the microbial barrier ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ NOTE The loss of sterile package integrity is usually regarded as event-related rather than time-related NOTE The maintenance of sterility by a packaging material and/or system is judged by the ability of the packaging to prevent the ingress of micro-organisms Many factors affect the extent of such ingress These include, but are not limited to: ± the level of micro-organisms in the environment; ± the sizes of particles on which the micro-organisms occur; ± environmental conditions of temperature, humidity and pressure and the rate of change of these conditions; ± flow rates through the layers of packaging material; ± pore size and other filtration parameters of the packaging material In order to determine which of the particular performance requirements have to be verified the packaging material and/or system shall be classified, if appropriate, for the following criteria a) Air impermeability of the packaging material b) Microbial barrier properties of the packaging material c) Microbial barrier properties of permeable closures (filter assembly; tortuous path) d) Impermeability and continuity of seals formed by fusion or adhesion e) Impermeability of seals not formed by fusion or adhesion (i.e sealing gaskets or valves) NOTE Guidance for this classification is given in annex B NOTE Evidence that the packaging material and/or systems does not contain material known to be toxic in sufficient quantity to cause a health hazard should be sufficient to meet this requirement BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 4.7 Storage and transport The packaging material and/or system shall be wrapped to provide the protection necessary to maintain the performance characteristics of the packaging material and/or system during storage and transport under the specified conditions, if applicable Test methods 5.1 The rationale for the selection of test methods, the variables to be determined, and the acceptance criteria shall be documented For some of the requirements, internationally accepted validated test methods are not yet available Until such time that these tests are available, the applied test method shall be validated and documented NOTE The listing of test methods in the informative annexes of this standard does not eliminate the need for validation nor does it exclude other validated test methods 5.2 Conditioning of test samples Unless otherwise specified in the test method, test samples shall be conditioned in accordance with the method given in EN 20187 at (23 ± 1) ÊC and (50 ± 2) % relative humidity Documentation The following information shall be supplied, if applicable: a) the nature and extent of any identified risks associated with the use of the packaging material and/or system; b) any particular restriction on use; c) any specific handling requirements; d) any specific storage conditions; e) the sterilization process for which the packaging material and/or system are intended; f) any known restrictions on environmental conditions during use; g) the type, size and grade of the packaging material and/or system; h) batch number or other means of tracing the manufacturing history; i) for re-usable packaging materials and/or systems, instructions on the frequency and nature of maintenance; j) any information pertinent to the packaged medical device as may be required (see prEN 1041); k) the expiry date of the packaging material and/or system ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ All test procedures, and the results obtained used to demonstrate compliance with the requirements of this standard shall be fully documented and retained securely for a specified period of time considering factors as e.g expiry date of the packaging material and/or system, traceability BSI 1997 Information NOTE Conformity with prEN 868-2 and the following Parts should also be stated, if relevant Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 Annex A (informative) Guidance on clause `Requirements' The headings of the sub-clauses of this annex are those of the sub-clauses of clause of the standard to which this guidance refers A.1 General A.1.1 The packaging of the medical device is done in two phases: 1) production of the packaging material (e.g rolls of material, bags, pouches, sheeted materials etc.); 2) application of the packaging material; e.g producing the wrapped medical device A.1.2 In general the responsibility for the quality of the packaging material is divided accordingly, where: 1) the manufacturer of the packaging material and/or system is responsible for the quality of the packaging material as it is being supplied, and the identification of the intended use; 2) the user of the packaging material and/or system for its proper application and by implication for the final quality of the packaging design or system A.2 Sterilization process compatibility of packaging materials and/or systems A.2.1 The manufacturer of the packaging material and/or system should have documented evidence on file to prove that the packaging material and/or system is suitable for the intended use This should include the sterilization process If the user of the packaging material intends to use the packaging to form packs according to his own design specifications he should verify the compatibility with the possible support of the manufacturer of the packaging material and/or system A.2.2 If the packaging material is used in other processes than specified by the manufacturer of the packaging material and/or system full demonstration of compatibility should be provided by the user of the packaging material and/or system Typically references are made to European Standards A.3 Design A.3.2 Compatibility with the medical device When selecting the packaging material and/or system the user of the packaging material and/or system should evaluate the compatibility for the intended use and the influence of the packaging on its intended content The manufacturer of the packaging material and/or system can contribute by supplying particular performance characteristics (e.g tear resistance) A.3.3 Compatibility with the labelling system The labelling is part of the application of the packaging material and/or system However, the manufacturer of the packaging material and/or system can be asked for information to be supplied about particular characteristics of the packaging material and/or system (e.g reaction to chemicals of a specific nature) Its compatibility should be verified by the user of the packaging material and/or system A.4 Toxicity This requirement should be verified by the manufacturer of the packaging material and/or system and information should be supplied to the user for his verification ｗｗｗ．ｂｚｆｘｗ．ｃｏｍ A.5 Biocompatibility Information on the biocompatibility of the packaging material and/or system may be available from the manufacturer of the packaging material and/or system and supplied to the user for the user's biocompatibility assessment A.6 Sterility maintenance Maintenance of sterility depends on the conditions of storage and handling The manufacturer of the packaging material and/or system therefore will normally verify the packaging material's and/or system's performance under specified conditions Whether or not the final pack will comply with the relevant requirements depends on the way the packaging material and/or system is applied and should be demonstrated by the user of the packaging material and/or system A.3.1 General requirements The manufacturer of the packaging material and/or system should, if applicable have proof of compliance on file The suitability of the final pack for its intended use is normally evaluated by the user of the packaging material and/or system BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page EN 868-1 : 1997 Annex B (informative) Microbial barrier evaluation scheme (see 4.6) This scheme should be followed for all materials, seals and/or closures used in the packaging individually Microbial barrier evaluation Is the packaging material intended to be permeable to air? Yes No Perform the air impermeability test Examples are given in annex C Is it desirable to perform the microbial barrier test? Yes Perform the microbial barrier test Examples are given in annex D No Material qualification Figure B.1 Microbial barrier evaluation scheme BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 10 EN 868-1 : 1997 Are all materials qualified as a microbial barrier? No Yes Does the packaging system use seals to provide a microbial barrier? Perform the test for determination of the impermeability and continuity of seals Examples are given in annex F Yes No Does the packaging system use any closures? Yes Is the closure intended to be air permeable? No Yes No Perform the microbial barrier test for impermeable closures Examples are given in annex G Perform the microbial properties test for permeable closures Examples are given in annex E Are all seals and/or closures qualified as a microbial barrier? Yes No Packaging system NOT qualified Packaging system qualified Figure B.1 Microbial barrier evaluation scheme (continued) BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 11 EN 868-1 : 1997 Annex C (informative) Air impermeability Ð Test methods The impermeability of packaging materials can be demonstrated by the selection of one of the appropriate methods below C.1 Gurley Method; ISO 5636-5 Paper and board Ð Determination of air permeance (medium range) Ð Part 5: Gurley method Test requirement, suggested limit: After h cylinder movement # mm This corresponds to a permeability less than or equal to 1,67 1023 mm/(Pa´s) C.2 Schopper Method Ð ISO 5636-2 Paper and board Ð Determination of air permeance (medium range) Ð Part 2: Schopper method Test requirement, suggested limit: A material having a permeability less than or equal to 1,67 1023 mm/(Pa´s) can be considered as impermeable C.3 Method for the determination of the impermeability of materials Test requirement, suggested limit: No staining of the absorption paper due to dye penetration C.3.1 Apparatus and reagents C.3.1.1 A weighted sponge, made from a block of cellulose sponge of nominal dimensions 110 mm 75 mm 32 mm bonded with a waterproof adhesive to a steel plate 110 mm 75 mm 12 mm such that the total mass is (800 ± 50) g C.3.1.2 A flat glass surface C.3.1.3 Absorption paper, white, medium or medium/fast absorption filter, or chromatography paper C.3.1.4 Dye solution, g/100 ml aqueous amaranth red containing 0,005 % cetrimide (a mixture of dodecyl-, tetradecyl- and hexadecyl-, trimethylammonium bromide) as a wetting agent C.3.1.5 A shallow tray, not less than 15 mm deep and of minimum dimensions 130 mm 95 mm C.3.2 Preparation of test samples Take five conditioned samples each with an area of less than 250 mm 105 mm Identify the surface which will be on the inside of the final pack C.3.3 Procedure Place a piece of absorption paper of similar size to the test sample on the flat glass surface, and place the inner surface of the material to be tested in contact with the absorption paper Pour the dye into the shallow tray and stand the sponge in the tray for Remove the sponge draining surplus liquid off on the edge of the tray BSI 1997 Place the sponge on the test sample ensuring that the edge of the sponge is not within 15 mm of the edge of the test sample and allow to stand for Remove the sponge and examine the absorption paper for staining due to penetration of the dye Repeat the procedure for the remaining test samples C.3.4 Test report Report the number of test samples where staining of the absorption paper occurs Annex D (informative) Microbial barrier properties Ð Test methods for materials The following test methods can be considered: ± DIN 58953-6 : 1987 Sterilization Ð Sterile supply Ð Sterilization paper for bags and tube packings Ð test; sub-clause 2.14: Testing for germ proofness in moisture and clause 15: Testing for germ proofness with passage of air ± BS 6256 : 1989 Paper for steam sterilization Ð paper bags, pouches and reels for medical use appendix C: Methods for determination of methylene blue particulate penetration ± SS 876 0019 Health care textiles Ð Bacterial penetration Ð Wet ± Test method for the microbial barrier properties of wrapping materials, new approach; report Nr 319 011.007 RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands ± Test method for the microbial barrier properties of packaging for medical devices, report Nr 31900 11.012, annex 7, RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands ±ASTM F 1608 Standard test method for microbial ranking of porous packaging materials (exposure chamber method) Annex E (informative) Microbial barrier properties Ð Test methods for permeable closures (filter assembly, tortuous path) The following test methods can be considered: ± Test method for the microbial barrier properties of wrapping materials, new approach; report Nr 319 011.007 RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands ± Test method for the microbial barrier properties of packaging for medical devices, report Nr 31900 11.012, annex 7, RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 12 EN 868-1 : 1997 Annex F (informative) Impermeability and continuity of seals formed by fusion or adhesion Ð Test methods Annex G (informative) Impermeability of seals not formed by fusion or adhesion Ð Test method Ð Test procedure for rigid containers Test for integrity of seals using packaging material impermeable to liquids G.1 Principle This test method can be used to determine the capability of container seals to preserve an under atmospheric pressure for at least 10 under a condition where the container is stressed with an external excess pressure up to the elastic limits To establish the specific elastic limit of this product, a container of the same make and size as the test container is investigated in a pilot test The test container is then stressed up to the pressure value determined in the pilot test G.2 Pilot test (Conditioning) G.2.1 Test sample The largest possible and empty container of a type G.2.2 Test apparatus ± Vacuum pump, capacity approximately 20 l/min ± Pressure gauge, with a range from to 25 kPa, accuracy class 1,6 (see prEN 837-1) ± Stop valve ± Test cap, in accordance with figure G.1, covering the sterilant port of the container whatever its type G.2.3 Procedure Place the test cap on the container ensuring that it forms a gastight seal with the container Evacuate the container Establish the point on the surface at which the greatest deformation appears and at which under atmospheric pressure the deformation starts G.3 Pilot test G.3.1 Test apparatus Apparatus as specified in G.2.2 and additional ± measurement system, to qualify a permanent deformation of the container G.3.2 Procedure Place the test cap on the container ensuring that it forms a gastight seal with the container Establish the under atmospheric pressure at which a permanent deformation of (5 ± 0,5) mm occurs, through alternate evacuation and ventilation 20 kPa will be settled as final value provided that at 20 kPa a value of mm is achieved G.4 Main test G.4.1 Test sample Two containers with the same dimensions as used in G.2.1 G.4.2 Procedure Place the test cap on the container ensuring that it forms a gastight seal with the container Evacuate kPa below the under atmospheric pressure established in G.3.2 Close the stop valve Read the under atmospheric pressure after 10 G.5 Results The test is regarded as valid, if both containers maintain an under atmospheric pressure F.1 Background information Test procedure for seals according to leaflet 45 Test for the integrity of seals method A from the Fraunhofer-Institute for food technology and packaging in Munich (Merkblatt 45 PruÈfung von HeibsiegelnaÈhten auf Dichtigkeit; Verpackungs-Rundschau 5/1982; 30-33) F.2 Equipment and reagents F.2.1 Cutter and pasteur pipette, rubber gloves or syringe with needle and rubber gloves F.2.2 Test solution 0,15 % 0,15 % 5,0 % 94,7 % Rhodamin B surfactant propan-1-ol distilled water F.3 Preparation of the test samples ± Cut the test sample with the cutter in the middle on one side ± Take out the product and fold the sample in that way that the opened side is at the top Or ± Fill the closed package using the syringe and close the puncture with an adhesive film F.4 Procedure F.4.1 Transparent and opaque packages Let one to five drops of the test solution flow down on every seal using the pasteur pipette or syringe Make sure that the seal is totally moistened Keep the sample this way for 15 F.4.2 Non-transparent packages Same way like transparent packages, but remove excessive test solution after moistening Dry the sample for 15 at 60 ÊC and peel to open the seals carefully by hand Packages filled by syringe are to be cut open in the middle before drying F.4.3 Test report The number of dye penetrations and their position at the package are documented Test requirement, suggested limit: No dye penetration completely through the seal F.5 Other Take care not to come in contact with the test solution because it is difficult to remove the colour spots BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 13 EN 868-1 : 1997 BSI 1997 Stop valve Sealing test cap Vacuum pump Pressure gauge Figure G.1 Testcap Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 14 EN 868-1 : 1997 Annex H (informative) Bibliography EN 285 EN 556 prEN 837-1 prEN 868-2 prEN 868-3 PrEN 868-4 prEN 868-5 prEN 868-6 prEN 868-7 prEN 868-8 Sterilization Ð Steam sterilizers Ð Large sterilizers Ð Requirements and tests Sterilization of medical devices Ð Requirements for medical devices to be labelled `Sterile' Pressure gauges Ð Part 1: Bourdon tube pressure gauges Ð Dimensions, metrology; Requirements and testing Packaging materials and systems for medical devices which are to be sterilized Ð Part 2: Sterilization wrap Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 3: Paper for use in the manufacture of paper bags (specified in Part of this standard) and in the manufacture of pouches and reels (specified in Part of this standard) Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 4: Paper bags Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 5: Heat sealable pouches and reel materials of paper and plastic film construction Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation Ð Requirements and test methods Packaging materials and systems for medical devices which are to be sterilized Ð Part 8: Re-usable containers for steam sterilizers conforming to prEN 285 Ð Requirements and test methods prEN 1041 Terminology, symbols and information provided with medical devices Ð Information supplied by the manufacturer with medical devices prEN 1422 Sterilizers for medical purposes Ð Ethylene oxide sterilizers Ð Specification EN 46001 Quality systems Ð Medical devices Ð Particular requirements for the application of EN ISO 9001 EN 46002 Quality systems Ð Medical devices Ð Particular requirements for the application of EN ISO 9002 EN ISO 9001 Quality systems Ð Model for quality assurance in design/development, production, installation and servicing (ISO 9001 : 1994) EN ISO 9002 Quality systems Ð Model for quality assurance in production, installation and servicing (ISO 9002 : 1994) prEN ISO Biological evaluation of medical 10993-1 devices Ð Part 1: Evaluation and testing (ISO/DIS 10993-1 : 1995) ISO 11607 Packaging for terminally sterilized medical devices DIN 58953-6 : Sterilization Ð Sterile supply Ð 1987 Sterilization paper for bags and tube packings Ð Test BS 6256 : 1989 Paper for steam sterilization paper bags, pouches and reels for medical use SS 876 0019 Health care textiles Ð Bacterial penetration Ð Wet ISO 5356-2 Paper and board Ð Determination of air permeance (medium range) Ð Part 2: Schopper method ISO 5356-5 Paper and board Ð Determination of air permeance (medium range) Ð Part 5: Gurley method Test method for the microbial barrier properties of wrapping materials, new approach; report Nr 319 011.007 RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands Test method for the microbial barrier properties of packaging for medical devices, report Nr 31900 11.012, annex 7, RIVM (Rijksinstituut voor volksgezondheid en milieuhygiene), Netherlands ASTM F 1608 Standard test method for microbial ranking of porous packaging materials (exposure chamber method) Merkblatt 45, Verpackungs-Rundschau 5/1982; PruÈfung von HeibsiegelnaÈhten auf Dichtigkeit, Herausgegeben von den Arbeitsgruppen der Industrievereinigung fuÈ r Lebensmitteltechnologie und Verpackung e V am Fraunhofer-Institut fuÈr Lebensmitteltechnologie und Verpackung, Institut an der Technischen UniversitaÈt MuÈnchen BSI 1997 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI Page 15 EN 868-1 : 1997 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provision of EU Directives This European Standard 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 93/42/EEC Warning Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard The following clauses of this standard are likely to support requirements of Directive 93/42/EEC Compliance with these clauses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulators Table ZA.1 Correspondence between this European Standard and EU-Directives Clauses/sub-clauses of this European Standard Corresponding ERs of Directive 93/42/EEC 4.1 to 4.7 I.1, I.2 4.3.1, I.3 4.1 to 4.7 I.4 4.3.2 I.5 4.1 to 4.7 I.6 4.1.1, 4.1.2, 4.3.1, 4.3.2 7.1 4.4, 4.5 7.2 4.3 7.3 4.3.2, 4.6 4.1 to 4.7 Qualifying remarks Test clause 5; informative annexes 7.4, 7.5, 7.6 Not applicable 8.1, 8.2 Not applicable 8.3 8.4, 8.5 Not applicable 8.6 Test clause 5.0, informative annexes 8.7 Not applicable 9.1, 9.2, 9.3, 10.1, 10.2, 10.3, 11, Not applicable 12, 13.1, 13.2 7a, b), e), j) 7a to l) BSI 1997 13.3 Under the Medical Device Directive these requirements pertain to the packed medical device not to labelling supplied with packaging materials and/or systems 13.4 To be verified by inspection 13.5 Not applicable 13.6a to 13.6h To be verified by inspection of information supplied 13.6i to 13.6p; 14 Not applicable Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:49:44 BST 2006, Uncontrolled Copy, (c) BSI BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð British Standards Institution BSI is the independent national body responsible for preparing British Standards It presents the UK view on standards in Europe and at the international level It is incorporated by Royal Charter Revisions British Standards are updated by amendment or revision Users of British Standards should make sure that they possess the latest amendments or editions It is the constant aim of BSI to improve the quality of our products and services We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover Tel: 020 8996 9000 Fax: 020 8996 7400 BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Customer Services Tel: 020 8996 9001 Fax: 020 8996 7001 In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British Standards, unless otherwise requested Information on standards BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service Various BSI electronic information services are also available which give details on all its products and services Contact the Information Centre Tel: 020 8996 7111 Fax: 020 8996 7048 Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards For details of these and other benefits contact Membership Administration Tel: 020 8996 7002 Fax: 020 8996 7001 Copyright Copyright subsists in all BSI publications BSI also holds the copyright, in the UK, of the publications of the international standardization bodies Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means ± electronic, photocopying, recording or otherwise ± without prior written permission from BSI This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained If permission is granted, the terms may include royalty payments or a licensing agreement Details and advice can be obtained from the Copyright Manager Tel: 020 8996 7070