BS EN 868 10 2009 ICS 11 080 30; 55 040 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Packaging materials for terminally sterilized medical devices Part 10 Ad[.]
BRITISH STANDARD Packaging materials for terminally sterilized medical devices Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods ICS 11.080.30; 55.040 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 868-10:2009 BS EN 868-10:2009 National foreword This British Standard is the UK implementation of EN 868-10:2009 It supersedes BS EN 868-10:2000 which is withdrawn The UK participation in its preparation was entrusted to Technical Committee LBI/35, Sterilizers, autoclaves and disinfectors A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract Users are responsible for its correct application Compliance with a British Standard cannot confer immunity from legal obligations This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2009 © BSI 2009 ISBN 978 580 59169 Amendments/corrigenda issued since publication Date Comments BS EN 868-10:2009 EUROPEAN STANDARD EN 868-10 NORME EUROPÉENNE EUROPÄISCHE NORM May 2009 ICS 11.080.30 Supersedes EN 868-10:2000 English Version Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines Requirements and test methods Matériaux d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 10: Non tissés base de polyoléfines, enduits d'adhésif, pour la fabrication de sachets, gaines et opercules thermoscellables - Exigences et méthodes d'essai Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 10: Klebemittelbeschichtete Faservliesmaterialien aus Polyolefinen - Anforderungen und Prüfverfahren This European Standard was approved by CEN on 23 April 2009 CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member This European Standard exists in three official versions (English, French, German) A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same 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 EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members Ref No EN 868-10:2009: E BS EN 868-10:2009 EN 868-10:2009 (E) Contents Page Foreword Introduction Scope Normative references Terms and definitions Requirements Information to be supplied by the manufacturer Annex A (informative) Details of significant technical changes between this European Standard and the previous edition .8 Annex B (normative) Method for the determination of mass per unit area of uncoated nonwoven polyolefine materials and adhesive coating .9 Annex C (normative) Method for the determination of the seal strength and visual inspection of the adhesive coating 11 Bibliography 13 BS EN 868-10:2009 EN 868-10:2009 (E) Foreword This document (EN 868-10:2009) 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 November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009 Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document supersedes EN 868-10:2000 Annex A provides details of significant technical changes between this European Standard and the previous edition EN 868 consists of the following parts, under the general title Packaging for terminally sterilized medical devices: Part 2: Sterilization wrap — Requirements and test methods; Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) — Requirements and test methods; Part 4: Paper bags — Requirements and test methods; Part 5: Sealable pouches and reels of porous materials and plastic film construction — Requirements and test methods; Part 6: Paper for low temperature sterilization processes — Requirements and test methods; Part 7: Adhesive coated paper for low temperature sterilization processes — Requirements and test methods; Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 — Requirements and test methods; Part 9: Uncoated nonwoven materials of polyolefines — Requirements and test methods; Part 10: Adhesive coated nonwoven materials of polyolefines — Requirements and test methods In addition, ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" has prepared the EN ISO 11607 series "Packaging for terminally sterilized medical devices" The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1) and validation requirements for forming, sealing and assembly processes (Part 2) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, 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 the United Kingdom BS EN 868-10:2009 EN 868-10:2009 (E) Introduction The EN ISO 11607 series consists of two parts under the general title "Packaging for terminally sterilized medical devices" Part of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use Part of this series specifies validation requirements for forming, sealing and assembly processes Every sterile barrier system shall fulfil the requirements of EN ISO 11607-1 The EN 868 series can be used to demonstrate compliance with one or more of the requirements specified in EN ISO 11607-1 During the revision of EN 868 parts to 10 CEN/TC 102/WG recognized Resolution CEN/BT 21/2003 relating to the implementation of the uncertainty of measurement concept in standards Following this Resolution and the corresponding guidance, CEN/TC 102/WG has initiated a review of the test methods needed to show compliance with the requirements specified in EN 868 parts to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts to 10 during one of their next revisions CEN/TC 102/WG also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts of the EN 868 series BS EN 868-10:2009 EN 868-10:2009 (E) Scope This part of EN 868 provides test methods and values for sealable adhesive coated nonwoven materials of polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use NOTE The need for a protective packaging may be determined by the manufacturer and the user This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1 As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1 NOTE When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply The materials specified in this part of EN 868 are intended for single use only 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 EN 20811, Textiles — Determination of resistance to water penetration — Hydrostatic pressure test EN 21974, Paper — Determination of tearing resistance (Elmendorf method) (ISO 1974:1990) EN ISO 536, Paper and board — Determination of grammage (ISO 536:1995) EN ISO 1924-2, Paper and board — Determination of tensile properties — Part 2: Constant rate of elongation method (ISO 1924-2:1994) EN ISO 2758, Paper — Determination of bursting strength (ISO 2758:2001) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 5636-3, Paper and board — Determination of air permeance (medium range) — Part 3: Bendtsen method ISO 6588-2, Paper, board and pulps — Determination of pH of aqueous extracts — Part 2: Hot extraction ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times ASTM D 2724:1987, Test Methods for Bonded, Fused and Laminated Apparal Fabrics Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 apply BS EN 868-10:2009 EN 868-10:2009 (E) Requirements 4.1 General The requirements of EN ISO 11607-1 apply NOTE EN ISO 11607-1:2006, 5.1.4 refers to conditions during production and handling with respect to their impact on the product (e.g electrostatic conductivity, bioburden if applicable) 4.2 Materials 4.2.1 The coated material shall be translucent or opaque and made of continuous filaments of polyolefines of a high level of purity and shall not release any substances in such quantities as could constitute a health risk NOTE Attention is drawn to EN ISO 10993-1 4.2.2 The coated material shall not react with, contaminate, transfer to, or adversely affect the product packed in it, before, during or after sterilization 4.3 Performance requirements and test methods 4.3.1 No colour shall leach out of the material Compliance shall be tested by visual examination of a hot extract prepared in accordance with the method given in ISO 6588-2 modified to test temperature of (60 ± 5) °C 4.3.2 The average mass of m² of the conditioned material when tested in accordance with EN ISO 536 shall be within ± 15 % of the nominal value stated by the manufacturer 4.3.3 The tensile strength of the conditioned material shall be not less than 4,8 kN/m in the machine direction and not less than 5,0 kN/m in the cross direction when tested in accordance with EN ISO 1924-2 4.3.4 The internal tearing resistance of the conditioned material shall be not less than 000 mN in both machine and cross directions when tested in accordance with EN 21974 4.3.5 The delamination factor of the conditioned material shall be not less than N/25,4 mm when tested in accordance with ASTM D 2724:1987 4.3.6 The bursting strength of the conditioned material shall be not less than 575 kPa when tested in accordance with EN ISO 2758 4.3.7 The air permeance of the conditioned material shall be not less than 0,3 µm/Pa ⋅ s at an air pressure of 1,47 kPa when tested in accordance with ISO 5636-3 This requirement need not to apply to materials solely for use in irradiation sterilization packaging 4.3.8 The resistance to water penetration of the nonwoven wrap shall be determined using the hydrostatic head test based on EN 20811 This test method is currently under revision and considering other test conditions (use of support screen with an open area greater than 50 % in order to avoid early fabric rupture) Minimum requirements will be set as soon as the revised test method is available Manufacturers may report test results 4.3.9 The mass per unit of the seal adhesive coating shall be within ± g/m² of that stated by the manufacturer Compliance shall be tested in accordance with the method given in Annex B 4.3.10 The seal strength of the coated material shall be greater than 0,08 kN/m when tested in accordance with Annex C BS EN 868-10:2009 EN 868-10:2009 (E) Report whether the tail was supported or unsupported, see C.5 4.3.11 The coating shall be continuous and regular with no uncoated areas or discontinuity in the coating pattern which could provide gaps or channels in a seal NOTE 4.4 The test method for the determination of the continuity of the coating depends on the applied coating system Marking of the protective packaging The protective packaging shall be legibly and durably marked with the following information: a) reference, stock or catalogue number; b) quantity; c) the manufacturer's or supplier's name or trade name, and address; d) date of manufacture in accordance with ISO 8601; e) lot number1; f) nominal mass in grams per square metre; g) nominal sheet size in millimetres or nominal width of rolls in millimetres and length in metres; h) the recommended storage conditions Information to be supplied by the manufacturer The manufacturer shall supply instructions for recommended sealing and/or closure conditions and for the monitoring of critical parameters of seal and/or closure integrity NOTE For validation of closure and sealing conditions, see EN ISO 11607-2 NOTE For heat seals, these parameters include the range of temperature, pressure and time NOTE For requirements on information to be provided by the manufacturer national or regional legislation can apply, see in particular Directive 93/42/EEC, Annex I, Section 13 A reference number in order to trace the manufacturing history of the product BS EN 868-10:2009 EN 868-10:2009 (E) Annex A (informative) Details of significant technical changes between this European Standard and the previous edition Changes between this European Standard and EN 868-10:2000 are the following: a) b) changes in order to align this European Standard with the EN ISO 11607 series, in particular by 1) amending the main element of the title, the scope and the terminology; 2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems; 3) deleting requirements that are covered by EN ISO 11607 (such as requirements on raw materials, conditioning, quality of the material with regard to tears, creases, localised thickening, leaching of toxic substances); in addition to a) first dash, the scope has been modified to 1) explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; 2) clarify that the materials covered by this European Standard are intended for single use only; c) an explanatory note has been inserted to refer the user of this European Standard to the general requirements on conditions during production and handling with respect to their impact on the product in EN ISO 11607; d) requirements on tensile strength in machine direction and on bursting strength have been amended; e) requirement on the tolerance of the thickness of the material has been deleted; f) the requirement on resistance to water penetration has been formulated by taking into consideration that the applicable test method in EN 20811 is currently under revision and that a value on resistance to water penetration can only be set on the basis of data received with this revised test method; g) requirements on coating have been amended to harmonize with other parts; h) requirements on marking have been amended; i) requirements on information to be provided by the manufacturer have been amended; j) test reports in the annexes have been amended; k) informative annex on dimensions and tolerances has been deleted; l) text has been revised editorially (e.g by updating normative and informative references) NOTE This list is not exhaustive BS EN 868-10:2009 EN 868-10:2009 (E) Annex B (normative) Method for the determination of mass per unit area of uncoated nonwoven polyolefine materials and adhesive coating B.1 Units All results shall be reported in units of grams per square metre (g/m²) B.2 Principle of method Samples of known areas are cut and weighed The adhesive coating is removed by extracting in a solvent The nonwoven polyolefine is dried, allowed to condition and then re-weighed The difference in mass between the original and the extracted samples is determined and the appropriate factor is applied to obtain the mass of the extracted coating B.3 Apparatus B.3.1 Hardened metal template Recommended dimensions 100 mm x 100 mm – factor 100; 100 mm x 50 mm – factor 200 B.3.2 Flat cutting sheet B.3.3 Cutting tool with sharp blade or alternately a combined circular cutter B.3.4 Continuous extraction apparatus e.g soxhlet comprising an extraction tube of approximately 100 ml volume and a reflux flask of 250 ml volume without use of a cartridge B.3.5 Electric thermostatically controlled flask heater sited in fume cupboard B.3.6 Fume cupboard with extraction fan and ventilation B.3.7 Analytical balance capable of measuring accurately to 0,1 mg B.3.8 Solvent B.3.9 Gloves, safety glasses, tongs B.4 Procedure B.4.1 Allow the test sample to condition B.4.2 Place the material to be tested on the cutting sheet BS EN 868-10:2009 EN 868-10:2009 (E) B.4.3 Place the template on the material, position firmly and cut around the edges with the cutting tool – alternatively use the circular cutter B.4.4 Cut out 10 samples in such a way as to get a good coverage across and along the sheet being tested B.4.5 Identify each sample by numbering with a pencil B.4.6 Weigh the samples individually on the analytical balance and record the mass of each alongside its number B.4.7 Add 150 ml of the solvent to the flask, extract the samples for h regulating the heating so that the solvent in the extraction tube is renewed every B.4.8 Remove the samples with tongs B.4.9 Dry off any solvent with a warm air current B.4.10 Allow the samples to recondition for 24 h at (23 ± 2) °C and (50 ± 5) % relative humidity B.4.11 Re-weigh the samples against their identification as in B.4.5 and B.4.6 B.5 Result Calculate the mass per square metre of the adhesive coating by the following equation: m3 = (m1 − m ) × f t (B.1) where ft is the template factor; m1 is the initial mass of the sample in grams; m2 is the mass of the sample after extracting and reconditioning in grams; m3 is the mass of the adhesive coating removed, in grams per square metre; m1 x ft the mass per square metre of the coated material; m2 x ft is the mass per square metre of the uncoated material B.6 Test report The test report shall include the following information: a) the maximum, minimum and average masses for uncoated paper and adhesive coating; b) on request, the identification of the product under test, the identification of the test-house and the date; c) the number of the standard that has been used for the test 10 BS EN 868-10:2009 EN 868-10:2009 (E) Annex C (normative) Method for the determination of the seal strength and visual inspection of the adhesive coating C.1 Units Results shall be reported in units of N/15 mm NOTE S.I unit is kN/m however N/15 mm is the more commonly used C.2 Principle of the method The adhesive coating is sealed to a consistent substrate under controlled conditions The seal strength is determined by cutting a strip at 90° through the seal and pulling it apart on a tensile machine meeting the requirements of EN ISO 1924-2 C.3 Apparatus C.3.1 Apparatus according to EN ISO 1924-2 C.3.2 Supply of material as used in the final pack C.3.3 Laboratory reference heat sealer with one jaw only heated C.3.4 Twin bladed knife or guillotine apparatus to cut strips 15 mm in width C.3.5 Flat cutting sheet if the knife is used C.4 Procedure C.4.1 Set the sealer to the conditions specified by the manufacturer (see Clause 5) C.4.2 When the above conditions are achieved, make test seals by sealing together the adhesive coated side of the material with the film selected in C.3.2 C.4.3 Cut five strips 15 mm wide at (90 ± 5)° to each seal, preferably 100 mm in length C.4.4 Following the guidelines of EN ISO 1924-2 pull the seals apart at a rate of application of tensile force of (200 ± 10) mm/min and record the maximum reading C.4.5 Visually inspect the seal patterns on the surface of the film for irregularities, gaps or channels C.5 Test report The test report shall include the following: 11 BS EN 868-10:2009 EN 868-10:2009 (E) a) the seal strength for each of the sample tested expressed in N/15 mm; b) whether the coating which has been transferred onto the surface of the film is regular or shows irregularities, gaps or channels; c) if the test has been performed with the tail supported or unsupported, data sheets and/or specifications; d) if testing of force per width via electric devices is in place the frequency applied by the electric device (data per second while measuring); e) on request, the identification of the product under test, the identification of the test-house and the date; f) the number of the standard that has been used for the test 12 BS EN 868-10:2009 EN 868-10:2009 (E) Bibliography [1] EN 1041, Information supplied by the manufacturer of medical devices [2] EN ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing (ISO 10993-1:2003) [3] EN ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) [4] 93/42/EEC, COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices 13 BS EN 868-10:2009 BSI - 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: +44 (0)20 8996 9000 Fax: +44 (0)20 8996 7400 BSI offers members an individual updating service called PLUS which ensures that subscribers 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