BS EN 868-10-2009 灭菌医疗装置的包装.聚烯烃粘性涂覆非织物材料.要求和测试方法.pdf
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1、 W - - - - - - - - - - - 7 - - 7 -7-7- - -7- - 7- - 7- - - - - - 7- - $ - - - - $ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - W W D - w - - - - EN 868-10:2009 (E) 2 Contents Page Foreword 3 Introduction .4 1Scope 5 2Normative references 5 3Terms and definitions .5 4Requirements
2、 .6 5Information to be supplied by the manufacturer 7 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 adhesi
3、ve coating .9 Annex C (normative) Method for the determination of the seal strength and visual inspection of the adhesive coating 11 Bibliography . 13 EN 868-10:2009 (E) 3 Foreword This document (EN 868-10:2009) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical purposes”,
4、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of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by November 2009. Attent
5、ion 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 c
6、hanges 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 (speci
7、fied 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
8、 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
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“
10、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). A
11、ccording 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, L
12、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. EN 868-10:2009 (E) 4 Introduction The EN ISO 11607 series consists of two parts under the general title “Packaging for terminally sterilized med
13、ical 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 maintain sterility of terminally sterilized medical devices to the point of use. Part 2 of this se
14、ries 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 revis
15、ion 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 corresponding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed to show
16、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 revisions. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the mini
17、mization 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. EN 868-10:2009 (E) 5 1 Scope This part of EN 868 provides test methods a
18、nd 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 1 The ne
19、ed 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 11
20、607-1. 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 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic present
21、ation (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.
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- BS EN 868-10-2009 灭菌医疗装置的包装.聚烯烃粘性涂覆非织物材料.要求和测试方法 868 10 2009 灭菌 医疗 装置 包装 烯烃 粘性 涂覆非 织物 材料 要求 测试 方法
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