DIN EN ISO 16672-2015 Ophthalmic implants - Ocular endotamponades (ISO 16672 2015) German version EN ISO 16672 2015《外科植入物 眼内填塞(ISO 16672-2015) 德文版本EN ISO 16672-2015》.pdf

1、December 2015 English price group 13No part of this translation 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 11.040.70!%JwF“2398435www.din.d

2、eDIN EN ISO 16672Ophthalmic implants Ocular endotamponades (ISO 16672:2015);English version EN ISO 16672:2015,English translation of DIN EN ISO 16672:2015-12Ophthalmische Implantate Okulare Endotamponaden (ISO 16672:2015);Englische Fassung EN ISO 16672:2015,Englische bersetzung von DIN EN ISO 16672:

3、2015-12Implants ophtalmiques Produits de tamponnement endoculaires (ISO 16672:2015);Version anglaise EN ISO 16672:2015,Traduction anglaise de DIN EN ISO 16672:2015-12SupersedesDIN EN ISO 16672:2003-06www.beuth.deDocument comprises 2 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the Germa

4、n-language original shall be considered authoritative.412.15 DIN EN ISO 16672:2015-12 2 A comma is used as the decimal marker. National foreword This document (ISO 16672:2015) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC

5、170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. The D

6、IN Standards corresponding to the International Standards referred to in this document are as follows: ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-6 DIN EN ISO 10993-6 ISO 11135-1 DIN EN ISO 11135 ISO 11137-1 DIN EN ISO 11137-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 13408-1 D

7、IN EN ISO 13408-1 ISO 14155 DIN EN ISO 14155 ISO 14630 DIN EN ISO 14630 ISO 14971 DIN EN ISO 14971 ISO 15223-1 DIN EN ISO 15223-1 ISO 17665-1 DIN EN ISO 17665-1 ISO 20857 DIN EN ISO 20857 EN 1041 DIN EN 1041 It should be noted that, in the German translation of this standard, the term “sterile barri

8、er system” has been translated as Sterilbarrieresystem and the term “sterile barrier” as Sterilverpackung. DIN EN ISO 16672:2015-12 3 Amendments This standard differs from DIN EN ISO 16672:2003-06 as follows: a) normative references have been updated; b) 3.7 “primary container”, 3.8 “sterile barrier

9、 system” and 3.9 “storage container” have been added; c) in Subclause 5.9, specifications for dynamic viscosity have been added; d) in Clause 11, the specifications for patient medical alert bracelets and patient information cards have been renderd more precise; e) Annex ZA “Relationship between thi

10、s European Standard and the Essential Requirements of EU Directive 93/42/EEC” has been revised; f) the text of the revised version ISO 16672:2015 has been adopted in its entirety. Previous editions DIN EN ISO 16672:2003-06 DIN EN ISO 16672:2015-12 4 National Annex NA (informative) Bibliography DIN E

11、N ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements DIN EN ISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local

12、 effects after implantation DIN EN ISO 11135, Sterilization of health care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements

13、for development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 13408-1, Aseptic processing of health ca

14、re products Part 1: General requirements DIN EN ISO 14155, Clinical investigation of medical devices for human subjects Good clinical practice DIN EN ISO 14630, Non-active surgical implants General requirements DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN E

15、N ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for development, validation and routine control of a steriliza

16、tion process for medical devices DIN EN ISO 20857, Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN 1041, Information supplied by the manufacturer of medical devices EUROPEAN STANDARD

17、 NORME EUROPENNE 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 Endotampo

18、naden (ISO 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 b

19、ibliographical 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 res

20、ponsibility 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 R

21、epublic of 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 NO

22、RMALISATION 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 Eoreword .1 Scope .2 Normative references 3 Terms and d

23、efinitions .4 Intended performance .5 Design attributes 5.1 General .5.2 Chemical and biological contaminants 5.3 Chemical description .5.4 Concentration of the components 5.5 Density .5.6 Gaseous expansion 5.7 Interfacial tension 5.8 Kinematic viscosity .5.9 Dynamic viscosity .5.10 Molecular mass d

24、istribution .5.11 Particulates.5.12 Refractive index 5.13 Spectral transmittance 5.14 Surface tension .5.15 Vapour pressure 6 Design evaluation .6.1 General 6.2 Evaluation of biological safety 6.2.1 General.6.2.2 Bacterial endotoxins test .6.2.3 Intraocular implantation test .6.2.4 Ethylene oxide .6

25、.3 Clinical investigation .7 Sterilization 8 Product stability 9 Integrity and performance of the delivery system .10 Packaging 10.1 Protection from damage during storage and transport10.2 Maintenance of sterility in transit .11 Information supplied by the manufacturer Annex A (normative) Intraocula

26、r implantation test .Annex B (informative) Clinical investigation 15Bibliography .Contents PageEuropean f 3Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .11111112121212121214EN ISO 16672:2015 (E) 2Foreword .566688888999999

27、99910101010101010101020DIN EN ISO 16672:2015-12 18European foreword This document (EN ISO 16672:2015) has been 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 Euro

28、pean Standard shall be given the status of a national standard, either by publication of an identical text or 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 e

29、lements 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 ISO 16672:2003. This document has been prepared under a mandate given to CEN by the European Commission and the Eu

30、ropean 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 document. The following referenced documents are indispensable for the application of this document. For undated r

31、eferences, the latest edition of the referenced document (including any amendments) applies. For dated references, 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 a

32、nd that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or 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

33、the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative 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

34、 in Clause 2 of the ISO standard Equivalent dated standard EN ISO ISO 10993-1:2009 EN ISO 10993-1:2009 + AC: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:

35、2007 ISO 11137:2006 + Amd 1:2013 EN ISO 11137-1:2006 + A1:2013 ISO 11137-1:2006 + Amd 1:2013 ISO 11607-1:2006 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

36、 1:2011 ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012 ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007 ISO 15223-1:2012 EN ISO 15223-1:2012 ISO 15223-1:2012 EN ISO 16672:2015 (E) 3DIN EN ISO 16672:2015-12 Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN IS

37、O ISO 17665-1:2006 EN ISO 17665-1:2006 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 Europea

38、n Standard: Austria, Belgium, Bulgaria, 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, Sloven

39、ia, Spain, Sweden, Switzerland, Turkey 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. EN ISO 16672:2015 (E) 4DIN EN ISO 16672:2015-12 ForewordISO (the International Organization for Standardization) is a w

40、orldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented

41、on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this

42、 document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Dir

43、ectives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the devel

44、opment of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO s

45、pecific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and

46、photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 16672:2003), which has been technically revised.5EN ISO 16672:2015 (E) DIN EN ISO 16672:2015-12 1 ScopeThis International Standard applies to ocular endotamponades (OE), a

47、group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical an

48、d clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references,

49、 only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1:2009, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-2:2006, Biological evaluation of medical devices Part 2: Animal welfare requirementsISO 10993- 6:2007, Biological evaluation of medical devices Part 6: Tests for local eff