BS EN ISO 16672-2015 Ophthalmic implants Ocular endotamponades《眼科植入物 眼内填塞》.pdf

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1、Ophthalmic implants Ocular endotamponades (ISO16672:2015)BS EN ISO 16672:2015Incorporating corrigendum +VOF 2017BSI Standards PublicationBS EN ISO 16672:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 16672:2015. It supersedes BS EN ISO 16672:2003 which

2、 is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/7, Eye implants.A list of organizations represented on this subcommittee can be obtained on request to its secretary.This publication does not purport to inclu

3、de all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017ISBN 978 0 580 97683 4ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations.This Br

4、itish Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2015.Amendments/corrigenda issued since publicationDate Text affected30+VOF2017 Implementation of CEN Correction Notice 2 September 2015: European foreword correctedEUROPEAN STANDARD NORME EU

5、ROPENNE EUROPISCHE NORM EN ISO 16672 August 2015 ICS 11.040.70 Supersedes EN ISO 16672:2003English Version Ophthalmic implants - Ocular endotamponades (ISO 16672:2015) Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2015) Ophthalmische Implantate - Okulare Endotamponaden (IS

6、O 16672:2015) This European Standard was approved by CEN on 7 May 2015. 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 bibliograp

7、hical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 translation under the responsibili

8、ty of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic o

9、f Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATI

10、ON EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16672:2015 EEN ISO 16672:2015 (E) 2 Contents Page European foreword .3 Anne

11、x ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 5 BS EN ISO 16672:2015g8g17g3g12g22g18g3g883g888g888g889g884g483g884g882g883g887g3g525g8g526iiiiivEN ISO 16672:2015 (E) 3 European foreword This document (EN ISO 16672:2015) has be

12、en prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” 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 o

13、r by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. 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 responsib

14、le for identifying any or all such patent rights. This document supersedes EN ISO 16672:2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with

15、 EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated refer

16、ences, only the edition cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC o

17、r ISO standard is referred to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in norm

18、ative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 10993-1:2009 EN ISO 10993-1:2009 + AC:

19、2010 ISO 10993-1:2009 + Cor 1:2010 ISO 10993-2:2006 EN ISO 10993-2:2006 ISO 10993-2:2006 ISO 10993-6:2007 EN ISO 10993-6:2009 ISO 10993-6:2007 ISO 11135-1:2007 EN ISO 11135-1:2007 ISO 11135-1:2007 ISO 11137:2006 + Amd 1:2013 EN ISO 11137-1:2006 + A1:2013 ISO 11137-1:2006 + Amd 1:2013 ISO 11607-1:200

20、6 EN ISO 11607-1:2009 ISO 11607-1:2006 ISO 13408-1:2008 + Amd 1:2013 EN ISO 13408-1:2011 + A1:2013 ISO 13408-1:2008 + Amd 1:2013 ISO 14155:2011 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor 1:2011 ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012 ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007 ISO

21、15223-1:2012 EN ISO 15223-1:2012 ISO 15223-1:2012 BS EN ISO 16672:2015g8g17g3g12g22g18g3g883g888g888g889g884g483g884g882g883g887g3g525g8g526iiiEN ISO 16672:2015 (E) 4 Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 17665-1:2006 EN ISO 17665-1:2006

22、ISO 17665-1:2006 ISO 20857:2010 EN ISO 20857:2013 ISO 20857:2010 EN 1041:2008 + A1:2013 EN 1041:2008 + A1:2013 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,

23、 Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey

24、and the United Kingdom. Endorsement notice The text of ISO 16672:2015 has been approved by CEN as EN ISO 16672:2015 without any modification. BS EN ISO 16672:2015g8g17g3g12g22g18g3g883g888g888g889g884g483g884g882g883g887g3g525g8g526ivEN ISO 16672:2015 (E) 5 Annex ZA (informative) Relationship betwee

25、n this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to the Essential Requirements of Directive 93/42

26、/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits

27、of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA Regulations. NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk management process needs to be in compl

28、iance with Directive 93/42/EEC, as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determinin

29、g acceptable risk must be in compliance with essential requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table of references in the European foreword, replacing the references in the core text. NOTE 4 When an Essentia

30、l Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/subclause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying r

31、emarks/notes 5.2 & 5.11, 7 in respect of EO contamination only. 7.2 6.3 7.37 7.6 7 8.15.2, 6.2.1 8.2 10, 11 in respect of exposure to environmental elements 8.3 7 in respect of EO sterilization 8.4 11 13.1 11 13.211 13.3 a), b), c), d), e), f), i), j), k), m) BS EN ISO 16672:2015g8g17g3g12g22g18g3g8

32、83g888g888g889g884g483g884g882g883g887g3g525g8g526vEN ISO 16672:2015 (E) 6 11 13.4 11 13.6 a), b), e), f), g) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 16672:2015g8g17g3g12g22g18g3g883g888g888g889g884g4

33、83g884g882g883g887g3g525g8g526viBS EN ISO 16672:2015ISO 16672:2015(E)Foreword iv1 Scope . 12 Normative references 1g885g3 g23g135g148g143g149g3g131g144g134g3g134g135g976g139g144g139g150g139g145g144g149 . 14 Intended performance . 35 Design attributes 35.1 General . 35.2 Chemical and biological conta

34、minants 35.3 Chemical description . 35.4 Concentration of the components 4g887g484g887g3 g7g135g144g149g139g150g155 . 45.6 Gaseous expansion 45.7 Interfacial tension 4g887g484g890g3 g14g139g144g135g143g131g150g139g133g3g152g139g149g133g145g149g139g150g155 . 4g887g484g891g3 g7g155g144g131g143g139g133

35、g3g152g139g149g133g145g149g139g150g155 . 45.10 Molecular mass distribution . 45.11 Particulates. 45.12 Refractive index 45.13 Spectral transmittance . 55.14 Surface tension 55.15 Vapour pressure . 56 Design evaluation 56.1 General . 5g888g484g884g3 g8g152g131g142g151g131g150g139g145g144g3g145g136g3g

36、132g139g145g142g145g137g139g133g131g142g3g149g131g136g135g150g155 . 56.2.1 General 56.2.2 Bacterial endotoxins test 56.2.3 Intraocular implantation test 5g888g484g884g484g886g3 g8g150g138g155g142g135g144g135g3g145g154g139g134g135 66.3 Clinical investigation 67 Sterilization . 68 Product stability .

37、79 Integrity and performance of the delivery system 710 Packaging . 710.1 Protection from damage during storage and transport. 7g883g882g484g884g3 g16g131g139g144g150g135g144g131g144g133g135g3g145g136g3g149g150g135g148g139g142g139g150g155g3g139g144g3g150g148g131g144g149g139g150 711 Information suppl

38、ied by the manufacturer . 7Annex A (normative) Intraocular implantation test 9Annex B (informative) Clinical investigation 10Bibliography .13 ISO 2015 All rights reserved iiiContents PageviiedBS EN ISO 16672:2015g12g22g18g3g883g888g888g889g884g483g884g882g883g887g525g8g526viiiBS EN ISO 16672:2015ISO

39、 16672:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards g132g145g134g139g135g149g3g523g12g22g18g3g143g135g143g132g135g148g3g132g145g134g139g135g149g524g484g3g23g138g135g3g153g145g148g141g3g145g136g3g146g148g135g146g131g148g139g14

40、4g137g3g12g144g150g135g148g144g131g150g139g145g144g131g142g3g22g150g131g144g134g131g148g134g149g3g139g149g3g144g145g148g143g131g142g142g155g3g133g131g148g148g139g135g134g3g145g151g150g3g150g138g148g145g151g137g138g3 g12g22g18g3 g150g135g133g138g144g139g133g131g142g3 g133g145g143g143g139g150g150g135g

41、135g149g484g3 g8g131g133g138g3 g143g135g143g132g135g148g3 g132g145g134g155g3 g139g144g150g135g148g135g149g150g135g134g3 g139g144g3 g131g3 g149g151g132g140g135g133g150g3 g136g145g148g3 g153g138g139g133g138g3 g131g3 g150g135g133g138g144g139g133g131g142g3committee has been established has the right to

42、be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. g12g22g18g3 g133g145g142g142g131g132g145g148g131g150g135g149g3 g133g142g145g149g135g142g155g3 g153g139g150g138g3 g150g138g135g3 g12g144g150g135g148g144g1

43、31g150g139g145g144g131g142g3 g8g142g135g133g150g148g145g150g135g133g138g144g139g133g131g142g3 g6g145g143g143g139g149g149g139g145g144g3 g523g12g8g6g524g3 g145g144g3 g131g142g142g3 g143g131g150g150g135g148g149g3 g145g136g3electrotechnical standardization.The procedures used to develop this document an

44、d those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the g134g139g136g136g135g148g135g144g150g3g150g155g146g135g149g3g145g136g3g12g22g18g3g134g145g133g151g143g135g144g150g149g3g149g138g145g151g142g134g3

45、g132g135g3g144g145g150g135g134g484g3g3g23g138g139g149g3g134g145g133g151g143g135g144g150g3g153g131g149g3g134g148g131g136g150g135g134g3g139g144g3g131g133g133g145g148g134g131g144g133g135g3g153g139g150g138g3g150g138g135g3editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).g4g1

46、50g150g135g144g150g139g145g144g3g139g149g3g134g148g131g153g144g3g150g145g3g150g138g135g3g146g145g149g149g139g132g139g142g139g150g155g3g150g138g131g150g3g149g145g143g135g3g145g136g3g150g138g135g3g135g142g135g143g135g144g150g149g3g145g136g3g150g138g139g149g3g134g145g133g151g143g135g144g150g3g143g131g1

47、55g3g132g135g3g150g138g135g3g149g151g132g140g135g133g150g3g145g136g3g146g131g150g135g144g150g3g148g139g137g138g150g149g484g3g12g22g18g3g149g138g131g142g142g3g144g145g150g3g132g135g3g138g135g142g134g3g148g135g149g146g145g144g149g139g132g142g135g3g136g145g148g3g139g134g135g144g150g139g136g155g139g144g

48、137g3g131g144g155g3g145g148g3g131g142g142g3g149g151g133g138g3g146g131g150g135g144g150g3g148g139g137g138g150g149g484g3g3g7g135g150g131g139g142g149g3g145g136g3g131g144g155g3g146g131g150g135g144g150g3g148g139g137g138g150g149g3g139g134g135g144g150g139g976g139g135g134g3g134g151g148g139g144g137g3g150g138g

49、135g3g134g135g152g135g142g145g146g143g135g144g150g3g145g136g3g150g138g135g3g134g145g133g151g143g135g144g150g3g153g139g142g142g3g132g135g3g139g144g3g150g138g135g3g12g144g150g148g145g134g151g133g150g139g145g144g3g131g144g134g512g145g148g3on the ISO list of patent declarations received (see www.iso.org/patents).g4g144g155g3g150g148g131g134g135g3g144g131g143g135g3g151g149g135g134g3g139g144g3g150g138g139g149g3g134g145g133g151g143g135g144g150g3g139g149g3g139g144g136g145g148g143g131g150g139g145g144g3g137g139g152g135g144g3g136g145g148g3g150g138g135g