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

1、September 2009DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.080.30!$YVa“15451

2、62www.din.deDDIN EN 868-8Packaging for terminally sterilized medical devices Part 8: Re-usable sterilization containers for steam sterilizersconforming to EN 285 Requirements and test methodsEnglish version of DIN EN 868-8:2009-09Verpackungen fr in der Endverpackung zu sterilisierende Medizinprodukt

3、e Teil 8: Wiederverwendbare Sterilisierbehlter fr Dampf-Sterilisatoren nach EN 285 Anforderungen und PrfverfahrenEnglische Fassung DIN EN 868-8:2009-09SupersedesDIN EN 868-8:1999-08www.beuth.deDocument comprises pages21DIN EN 868-8:2009-09 National foreword This standard has been prepared by Technic

4、al Committee CEN/TC 102 “Sterilizers for medical purposes” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Technical Committee NA 063-04-04 AA Sterilgutversorgung. Amendments This standard differs fro

5、m DIN EN 868-8:1999-08 as follows: a) Changes in order to align this European Standard with the DIN EN ISO 11607 series, in particular by amending the main element of the title, the scope and the terminology; using DIN EN ISO 11607-1 as normative reference regarding the general requirements for mate

6、rials, sterile barrier systems and packaging systems; amending the requirements on lid and lid-latching devices, the tamper evident closure system, the gasket, the microbial barrier properties of the sterilant port and materials. b) In addition to a) first dash, the scope has been modified to explai

7、n that other requirements might be of relevance for additional materials being used inside a sterile barrier system. 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 imp

8、act on the product in DIN EN ISO 11607. d) Requirements on the design of handles have been amended to be more general. e) Requirements on robustness (forming) and stacking capability have been amended in order to improve verifiability. f) Requirements on service life have been amended. g) The test m

9、ethods for sterilization performance and load dryness have been amended on the basis of DIN EN 285:2006 (second edition). h) Requirements on information to be provided by the manufacturer have been amended. i) The text has been editorially revised (e.g. by updating normative and informative referenc

10、es). Previous editions DIN 58952-1: 1977-01 DIN 58946-2: 1972-08 DIN EN 868-8: 1999-08 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 868-8 May 2009 ICS 11.080.30 Supersedes EN 868-8:1999 English Version Packaging for terminally sterilized medical devices Part 8: Re-usable sterilization cont

11、ainers for steam sterilizers conforming to EN 285 Requirements and test methods Matriaux demballage pour les dispositifs mdicaux striliss au stade terminal Partie 8: Conteneurs rutilisables de strilisation pour strilisateurs la vapeur deau conformes lEN 285 Exigences et mthodes dessai Verpackungen f

12、r in der Endverpackung zu sterilisierende Medizinprodukte Teil 8: Wiederverwendbare Sterilisierbehlter fr Dampf-Sterilisatoren nach EN 285 Anforderungen und Prfverfahren This European Standard was approved by CEN on 23 April 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulat

13、ions 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 national standards may be obtained on application to the CEN Management Centre or to any CEN member. This Eur

14、opean 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 theofficial versions. CEN members are the na

15、tional 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

16、 United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 868-8:2

17、009: EEN 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 manufacturer 86 Test methods 9Annex A (informative) Details of significant technical changes between this European Standard

18、 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 device capability test . 14Annex F (normative) Determination of sterilization performance . 15Annex G (normative) L

19、oad dryness tests 16Annex H (informative) Guidance on determination of useful life 18Bibliography . 19DIN EN 868-8:2009-09 EN 868-8:2009 (E) 3 Foreword This document (EN 868-8:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”, the secretariat of which is he

20、ld 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 possibilit

21、y 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 868-8:1999. Annex A provides details of significant technical changes between this European St

22、andard 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 ma

23、nufacture 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

24、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 o

25、f 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 s

26、eries “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 Int

27、ernal 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, M

28、alta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 868-8:2009-09 EN 868-8:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized medical device

29、s“. 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 maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specif

30、ies 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 8

31、68 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 corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed to show compliance

32、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 revisions. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of

33、 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. DIN EN 868-8:2009-09 EN 868-8:2009 (E) 5 1 Scope This part of EN 868 provides test

34、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 intended to be used in steam sterilizers conforming to EN 285. NOTE 1 The need for a packaging materi

35、al 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 of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1. As suc

36、h, 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 a steam sterilizer not conforming to EN 285 the sterilization per-formance of the container in th

37、e 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 additional materials are used inside the sterile barrier system in order to ease the organizatio

38、n, 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 valid

39、ation 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 undated references, the latest edition of the referenced document (including any amendments) applie

40、s. 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 ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for ma

41、terials, 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, natural weathering or laboratory light sources 3 Terms and definitions For the purposes of this documen

42、t, 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 requirements for reusable containers. DIN EN 868-8:2009-09 EN 868-8:2009 (E) 6 NOTE 2 EN ISO 11607-

43、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 forming, sealing and assembly processes, see EN ISO 11607-2. 4.2 Requirements for construct

44、ion 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 corners is desirable. 4.2.1.2 The container including all connected parts e.g. handles shall

45、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 can claim compliance with EN ISO 11607-1, but not with EN 868-8. NOTE 2 For guidance on dime

46、nsions 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 lid. 4.2.2.2 The lid shall be secured to the base during use by locking devices. The closure

47、 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 available. 4.2.3.2 If the tamper evident closure system is not a single-use disposable item, i.e.

48、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 provided with a closure gasket. The closure formed by the gasket with the lid latched in position s

49、hall 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 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 suf