BS EN 868-3-1999 Packaging materials and systems for medical devices which are to be.pdf

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-3:1999 The European Standard EN 868-3:1999 has the status of a British Standard ICS 11.080.30; 55.040; NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW 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 EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Ð Requirements and test methods Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 November 1999 BSI 11-1999 ISBN 0 580 35316 8 BS EN 868-3:1999 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the English language version of EN 868-3:1999. It supersedes most of the normative text of BS 6256:1989, which is subject to amendment to this effect. BS 6256:1989 is not yet withdrawn, because reference is made to it in annex D of EN 868-1:1997, with reference to the possibility of applying the methylene blue particulate penetration test (described in appendix C of BS 6256) as a means of assessing the microbial barrier properties of some types of sterilization packaging covered by EN 868. 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: Ð aid enquirers to understand the text; Ð present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; Ð 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-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 ªInternational Standards Correspondence Indexº, or by using the ªFindº facility of the BSI Standards Electronic Catalogue. Sterilization packaging materials falling within the scope of EN 868-1 are considered to be medical devices under Directive 93/42/EEC and compliance with the requirements of EN 868-1 is a means of ensuring that particular essential requirements of the Directive are met (see annex ZA of EN 868-1). This part of EN 868 may be used to demonstrate compliance with some of the requirements of Part 1. However, compliance with this part of EN 868 alone may not necessarily be considered to ensure that the essential requirements of the Directive have been met. 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. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite  Europe Âen de Normalisation Europa Èisches Komitee fu Èr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-3:1999 E EUROPEAN STANDARDEN 868-3 NORME EUROPE ÂENNE EUROPA ÈISCHE NORM June 1999 ICS 11.080; 55.040 English version Packaging materials and systems for medical devices which are to be sterilizedÐ Part3:Paper for use in the manufacture of paper bags (specified in EN868-4) and in the manufacture of pouches and reels (specified in EN868-5)Ð Requirements and test methods Mate Âriaux et syste Ámes d'emballages pour les dispositifs me Âdicaux devant e Ãtre ste Ârilise Âs Ð Partie 3: Papier utilise  dans la fabrication de sacs en papier (spe Âcifie Âs dans l'EN 868-4) et dans la fabrication de sachets et gaines (spe Âcifie Âs dans l'EN 868-5) Ð Exigences et me Âthodes d'essai Verpackungsmaterialien und -systeme fu Èr zu sterilisierende Medizinprodukte Ð Teil 3: Papier zur Herstellung von Papierbeuteln (festgelegt in EN 868-4) und zur Herstellung von Klarsichtbeuteln und -schla Èuchen (festgelegt in EN868-5) Ð Anforderungen und Pru Èfverfahren This European Standard was approved by CEN on 13 May 1999. 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI Page 2 EN 868-3:1999 BSI 11-1999 Foreword 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 December 1999, and conflicting national standards shall be withdrawn at the latest by December 1999. This standard is one of a series of European Standards concerned with packaging materials and systems for medical devices which are to be sterilized. This series consists of the following parts. EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Ð Part 1: General requirements and test methods. EN 868-2, Packaging materials and systems for medical devices which are to be sterilized Ð Part 2: Sterilization wrap Ð Requirements and test methods. EN 868-3, 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 EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Ð Requirements and test methods. EN 868-4, Packaging materials and systems for medical devices which are to be sterilized Ð Part 4: Paper bags Ð Requirements and test methods. EN 868-5, Packaging materials and systems for medical devices which are to be sterilized Ð Part 5: Heat and self sealable pouches and reels of paper and plastic film construction Ð Requirements and test methods. EN 868-6, 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. EN 868-7, 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. EN 868-8, Packaging materials and systems for medical devices which are to be sterilized Ð Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 Ð Requirements and test methods. 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. Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Requirements3 Annex A (normative) Method for the determination of water repellency5 Annex B (normative) Method for the determination of pore size5 Annex C (informative) Dimensions and tolerances8 Annex D (informative) Bibliography8 Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m Page 3 EN 868-3:1999 BSI 11-1999 Introduction Part 1 of this series of European Standards 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. 1 Scope This part of the series of EN 868 provides examples of particular requirements and test methods for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5). It introduces no additional requirements to the general requirements of Part 1 but provides guidance based upon various elements of former, relevant national standards. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of Part 1. Paper specified in this part is suitable for use as packaging of medical devices which are to be terminally sterilized. 2 Normative references 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. EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Ð Part 1: General requirements and test methods. 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) EN 20535, Paper and board Ð Determination of water absorptiveness Ð Cobb method. (ISO 535:1991) EN 21974, Paper Ð Determination of tearing resistance (Elmendorf method). (ISO 1974:1990) EN 28601, Data elements and interchange formats Ð Information interchange Ð Representation of dates and times. (ISO 8601:1988 and technical corrigendum 1:1991) EN ISO 1924-2, Paper and board Ð Determination of tensile properties Ð Part 2: Constant rate of elongation method. (ISO 1924-2:1994) ISO 536, Paper and board Ð Determination of grammage. ISO 2758, Paper Ð Determination of bursting strength. ISO 3689, Paper and board Ð Determination of bursting strength after immersion in water. (Revision of ISO 3689:1976) ISO 3781, Paper and board Ð Determination of tensile strength after immersion in water. ISO 5636-3, Paper and board Ð Determination of air permeance (medium range) Ð Part 3: Bendtsen method. ISO 6588, Paper, board and pulps Ð Determination of pH of aqueous extracts. ISO 9197-1, Paper, board and pulps Ð Determination of water-soluble chlorides Ð Part 1: General method. ISO 9198, Paper, board and pulps Ð Determination of water-soluble sulfates Ð Titrimetric method. DIN 58953-6:1987, Sterilization Ð Sterile supply Ð Sterilization paper for bags and tube packings Ð Test. 3 Definitions For the purposes of this European Standard, the definitions of EN 868-1 apply. 4 Requirements 4.1 General The requirements of EN 868-1 apply. NOTEThe following particular requirements and test methods can be used to demonstrate compliance with one or more, but not all, of the requirements of EN 868-1. 4.2 Materials 4.2.1 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, are known and controlled to ensure that the finished product will consistently meet the requirements of this standard. NOTEWith 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. 4.2.2 The pulp shall be free from grit and untreated fragments of the original materials from which the pulp was prepared. 4.3 Conditioning Where reference is made in the following performance requirements to ªconditionedº paper or to the need for conditioning prior to carrying out a test the paper shall be conditioned in accordance with the method given in EN 20187. Licensed Copy: London South Bank University, London South Bank University, Wed Jul 12 21:50:40 BST 2006, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m Page 4 EN 868-3:1999 BSI 11-1999 1) A reference number in order to trace the manufacturing history of the product. 4.4 Performance requirements and test methods NOTEThe requirements of 4.4.12, 4.4.13 and 4.4.16 do not apply to materials solely for use in irradiation sterilization packaging. 4.4.1 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the paper shall be free from tears, creases or localized thickening sufficient to impair its functioning. 4.4.2 No colour shall leach out of the paper. Compliance shall be tested by visual examination of a hot aqueous extract prepared in accordance with the method given in ISO 6588. 4.4.3NOTEThe paper can be printed. Whether printed or not, no substance known to be toxic shall leach out of the paper in sufficient quantity to cause a health hazard. Until relevant European or International Standards are published National regulations can apply. 4.4.4 The average mass of 1 m2of the conditioned paper when tested in accordance with ISO 536 shall be within±5 % of the nominal value stated by the manufacturer. 4.4.5 The pH of an aqueous extract of the paper shall be not less than 5 nor greater than 8 when tested in accordance with ISO 6588, hot extraction method. 4.4.6 The chloride co