BS EN 868-8-2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285 Requirements and test methods《最.pdf

1、BS EN 868-8:2009ICS 11.080.30; 55.120NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDPackaging materialsfor terminallysterilized medicaldevicesPart 8: Re-usable sterilizationcontainers for steam sterilizersconforming to EN 285 Requirementsand test methodsThis Br

2、itish Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 31 October2009 BSI 2009ISBN 978 0 580 59167 9Amendments/corrigenda issued since publicationDate CommentsBS EN 868-8:2009National forewordThis British Standard is the UK implementation of EN 868-8:2009. Its

3、upersedes BS EN 868-8:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/35, Sterilizers, autoclaves and disinfectors.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purpor

4、t to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS EN 868-8:2009EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 868-8May 2009ICS 11.080.30 Supersedes EN 868-8:1

5、999 English VersionPackaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming toEN 285 - Requirements and test methodsMatriaux demballage pour les dispositifs mdicauxstriliss au stade terminal - Partie 8: Conteneursrutilisables d

6、e strilisation pour strilisateurs la vapeurdeau conformes lEN 285 - Exigences et mthodesdessaiVerpackungen fr in der Endverpackung zu sterilisierendeMedizinprodukte - Teil 8: WiederverwendbareSterilisierbehlter fr Dampf-Sterilisatoren nach EN 285 -Anforderungen und PrfverfahrenThis European Standard

7、 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 EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such na

8、tionalstandards 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 translationunder the responsibility of a CEN member into its own language and n

9、otified to the CEN Management Centre has the same status as theofficial 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, Ma

10、lta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploita

11、tion in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 868-8:2009: EBS EN 868-8:2009EN 868-8:2009 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Requirements .55 Information to be supplied by the manufacture

12、r 86 Test methods 9Annex A (informative) Details of significant technical changes between this European Standard and the previous edition 10Annex B (informative) Guidance on dimensions 11Annex C (normative) Handle strength test 12Annex D (normative) Stacking test . 13Annex E (normative) Stacking dev

13、ice capability test . 14Annex F (normative) Determination of sterilization performance . 15Annex G (normative) Load dryness tests 16Annex H (informative) Guidance on determination of useful life 18Bibliography . 19BS EN 868-8:2009EN 868-8:2009 (E) 3 Foreword This document (EN 868-8:2009) has been pr

14、epared 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

15、 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 s

16、upersedes EN 868-8:1999. 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

17、 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 an

18、d 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

19、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 pr

20、oducts“ 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 val

21、idation 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, Es

22、tonia, 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 868-8:2009EN 868-8:2009 (E) 4 Introduction The EN ISO 11607 se

23、ries consists of two parts under the general title “Packaging for terminally sterilized medical devices“. Part 1 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 maintai

24、n sterility of terminally sterilized medical devices to the point of use. Part 2 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 co

25、mpliance with one or more of the requirements specified in EN ISO 11607-1. During the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003 relating to the implementation of the uncertainty of measurement concept in standards. Following this Resolution and the corresp

26、onding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their next

27、 revisions. CEN/TC 102/WG 4 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

28、the EN 868 series. BS EN 868-8:2009EN 868-8:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are inte

29、nded to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part o

30、f 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 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1. NOTE 2 When it is intended to use the containers in

31、a steam sterilizer not conforming to EN 285 the sterilization per-formance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature. NOTE 3 When

32、 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 oth

33、er requirements, including the determination of the acceptability of these materials during validation activities, may apply. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For un

34、dated references, the latest edition of the referenced document (including any amendments) applies. EN 285:2006, Sterilization Steam sterilizers Large sterilizers EN 10088-1, Stainless steels Part 1: List of stainless steels EN ISO 4017, Hexagon head screws Product grades A and B (ISO 4017:1999) EN

35、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 4582, Plastics Determination of changes in colour and variations in properties after exposure to daylight under glass, natura

36、l weathering or laboratory light sources 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11607-1:2006 and EN 285:2006 apply. 4 Requirements 4.1 General The requirements of EN ISO 11607-1 apply. NOTE 1 EN ISO 11607-1, 5.1.10 specifies additional re

37、quirements for reusable containers. BS EN 868-8:2009EN 868-8:2009 (E) 6 NOTE 2 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). NOTE 3 For validation requirements for

38、 forming, sealing and assembly processes, see EN ISO 11607-2. 4.2 Requirements for construction and design 4.2.1 Shape and dimension 4.2.1.1 The container shall be in the general form of a parallelepipedal box. NOTE Slight curvature or camber of the flat surfaces can be acceptable. Rounding of the c

39、orners is desirable. 4.2.1.2 The container including all connected parts e.g. handles shall fit within one sterilization module (see EN 285). NOTE 1 If the container does not fit within one sterilization module, but complies with all other requirements of this part of the standard, the manufacturer

40、can claim compliance with EN ISO 11607-1, but not with EN 868-8. NOTE 2 For guidance on dimensions see informative Annex B. 4.2.1.3 For ease of cleaning all internal corners shall be radiused. 4.2.2 Lids and lid-latching devices 4.2.2.1 Access to the interior of the container shall be provided by a

41、lid. 4.2.2.2 The lid shall be secured to the base during use by locking devices. The closure shall comply with the requirements in EN ISO 11607-1:2006, 5.1.10 c). 4.2.3 Tamper evident closure system 4.2.3.1 A tamper evident closure system complying with EN ISO 11607-1:2006, 5.1.10 a) shall be availa

42、ble. 4.2.3.2 If the tamper evident closure system is not a single-use disposable item, i.e. does not irrevocably break when opened, then a special tool, key, code or treatment shall be required to re-set the closure system. 4.2.4 Gasket 4.2.4.1 The interface between the lid and base shall be provide

43、d with a closure gasket. The closure formed by the gasket with the lid latched in position shall provide microbial barrier properties as specified in EN ISO 11607-1:2006, 5.2 and 5.1.10 c). 4.2.4.2 The gasket shall be accessible for cleaning. Frequency and method of maintenance shall be specified by

44、 the manufacturer (see Clause 5). 4.2.5 Handles 4.2.5.1 Each container shall be provided with a suitable carrying device. 4.2.5.2 The carrying devices, the means of their attachment to the container, and the container itself shall be sufficiently robust to support the weight of the filled container

45、without permanent deformation 1 mm when tested in accordance with Annex C. If a permanent deformation is measured, performance characteristics of the container (in particular sterile barrier properties) shall be demonstrated to remain unchanged. BS EN 868-8:2009EN 868-8:2009 (E) 7 4.2.6 Stacking cap

46、ability 4.2.6.1 The top and base of each container shall be sufficiently strong to allow stacking and shall be fitted with means to ensure that all containers of the same nominal size and of the same provenance shall stack securely. After the test in accordance with Annex D, the container shall show

47、 no permanent deformation 1 mm and shall have unchanged performance characteristics. When tested in accordance with Annex E, the tested container shall remain stacked. 4.2.6.2 The containers shall be designed and constructed so that when stacked and loaded into the sterilizer in the manner specified

48、 by the manufacturer they will allow free passage of steam and/or air between containers. Compliance shall be tested by the performance tests carried out as described in Annex C to F. 4.2.7 Sterilant Port 4.2.7.1 Each container shall be provided with a sterilant port in one or more of its principle

49、surfaces. 4.2.7.2 The sterilant port shall be designed to meet the following requirements: a) It shall permit the attainment of the specified sterilization conditions. Compliance shall be tested in accordance with Annex F. b) It shall permit adequate drying when processed in a sterilizer conforming to EN 285. Compliance shall be tested in accordance with Annex G. c) It shall permit microbial barrier properties during removal, transport and subsequent storage as spe