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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 868-1 : 1997 The Eu
2、ropean 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 Packaging materials and systems for medical devices which are to be sterilized Part 1. General requirements and test methods Licensed Copy: s
3、heffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 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 19
4、97 BSI 1997 ISBN 0 580 27683 X BS EN 868-1 : 1997 Amendments issued since publication Amd. No.DateText affected 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
5、, 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 inf
6、ormed; 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 i
7、n 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 :
8、 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 On publication of the corresponding Parts of BS EN 868, the current British Standards will be withdrawn.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
9、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
10、with some of the requirements of Part 1. 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. T
11、hese materials are not a comprehensive list of those which may be used to achieve compliance with the requirements of Part 1. 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, t
12、he EN title page, pages 2 to 16, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central S
13、ecretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 868-1 : 1997 E EUROPEAN STANDARDEN 868-1 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.080; 55.040 Descriptors: Medical
14、 equipment, sterilization, packing, specifications, operating requirements, compatibility, storage English version Packaging materials and systems for medical devices whichareto be sterilized Part 1: General requirements and test methods Mate riaux et syste mes demballages pour les dispositifs me di
15、caux devant e tre ste rilise s Partie 1: Exigences ge ne rales et me thodes dessai Verpackungsmaterialien und -systeme fu r zu sterilisierende Medizinprodukte Teil 1: Allgemeine Anforderungen und Pru fverfahren This European Standard was approved by CEN on 1997-01-27. CEN members are bound to comply
16、 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 Secre
17、tariat 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 offic
18、ial 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:
19、32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 868-1 : 1997 BSI 1997 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
20、 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
21、 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 count
22、ries 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 c
23、oncerned with packaging materials and systems for medical devices which are to be sterilized. These other draft European Standards currently are: prEN 868-2Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap Requirements and test methods prEN 868
24、-3Packaging materials and systems for medical devices which are to be sterilized Part 3: Paper for use in the manufacture of paper bags (specified in Part 4 of this standard) and in the manufacture of pouches and reels (specified in Part 5 of this standard) Requirements and test methods prEN 868-4Pa
25、ckaging materials and systems for medical devices which are to be sterilized Part 4: Paper bags Requirements and test methods prEN 868-5Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat sealable pouches and reel material manufactured from paper and plastic R
26、equirements and test methods prEN 868-6Packaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methods prEN 868-7Packaging materials and systems
27、for medical devices which are to be sterilized Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation Requirements and test methods prEN 868-8Packaging materials and systems for medical devices which are to be steri
28、lized Part 8: Re-usable containers for steam sterilizers conforming to prEN 285 Requirements and test methods Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 868-1 : 1997 BSI 1997 Contents Page Foreword2 Introduction4 1Scope4 2Norm
29、ative references4 3Definitions4 4Requirements5 5Test methods7 6Documentation7 7Information7 Annex A (informative) Guidance on clause 4 Requirements8 Annex B (informative) Microbial barrier evaluation scheme (see 4.6)9 Annex C (informative) Air impermeability Test methods11 Annex D (informative) Micr
30、obial barrier properties Test methods for materials11 Annex E (informative) Microbial barrier properties Test methods for permeable closures (filter assembly, tortuous path)11 Annex F (informative) Impermeability and continuity of seals formed by fusion or adhesion Test methods12 Annex G (informativ
31、e) Impermeability of seals not formed by fusion or adhesion Test methods Test procedure for rigid containers12 Annex H (informative) Bibliography14 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provision of EU Directives15 Licensed Copy: sheffiel
32、dun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 868-1 : 1997 BSI 1997 Introduction 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 ter
33、minally 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
34、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 packa
35、ging process (see also European Standards on quality systems and ISO 11607). 1 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 intend
36、ed to maintain sterility of the device. NOTE 1. This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e.g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health c
37、are facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2. 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 stan
38、dard 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 IS
39、O 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. 2 Normative references This Euro
40、pean 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
41、 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 550Sterilization of medical devices Validation and routine control of ethylene oxide sterilization EN 552Sterilization of medic
42、al devices Validation and routine control of sterilization by irradiation EN 554Sterilization of medical devices Validation and routine control of sterilization by moist heat EN 20187 Paper, board and pulps Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere
43、and conditioning of samples (ISO 187 : 1990) 3 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 constr
44、uct 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 Ab
45、ility 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. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:32 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 868-1 : 1997 BSI 1997 3.
46、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 exampl
47、e 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 fro
48、m 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. 3.14 transport pack Pack containing one or more primary and/or secondary packs intended to provide the necessary protect
49、ion during transport and storage. 4 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 packa