DIN EN ISO 11979-4-2013 Ophthalmic implants - Intraocular lenses - Part 4 Labelling and information (ISO 11979-4 2008 + Amd 1 2012) German version EN ISO 11979-4 2008 + A1 2012《眼科植.pdf

1、January 2013Translation by DIN-Sprachendienst.English price group 9No 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

2、11.040.70!$j“1936171www.din.deDDIN EN ISO 11979-4Ophthalmic implants Intraocular lenses Part 4: Labelling and information (ISO 11979-4:2008 + Amd.1:2012);English version EN ISO 11979-4:2008 + A1:2012,English translation of DIN EN ISO 11979-4:2013-01Ophthalmische Implantate Intraokularlinsen Teil 4:

3、Etikettierung und Information (ISO 11979-4:2008 + Amd.1:2012);Englische Fassung EN ISO 11979-4:2008 + A1:2012,Englische bersetzung von DIN EN ISO 11979-4:2013-01Implants ophtalmiques Lentilles intraoculaires Partie 4: tiquetage et informations (ISO 11979-4:2008 + Amd.1:2012);Version anglaise EN ISO

4、11979-4:2008 + A1:2012,Traduction anglaise de DIN EN ISO 11979-4:2013-01SupersedesDIN EN ISO 11979-4:2009-03www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 14 pages12.12 A comma is used as the decimal marker. National foreword This docu

5、ment (EN ISO 11979-4:2008 + A1:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsibl

6、e German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. This document is the consolidated version of EN ISO 11979-4:2008. It incorporates Amendment A

7、1:2012 (EN ISO 11979-4:2008/A1:2012). The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standards corresponding to the European and International Standards referred to in this document are as follows: EN 980 DIN EN 980 EN 1041 DIN EN 1041 IS

8、O 11607-1 DIN EN ISO 11607-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 15223-1 DIN EN ISO 15223-1 In Germany, use of the symbol “dpt” for dioptre (expressed in m1; see comment to item 10 in Table 1) is legally required and this symbol is to be used rather than the symbol D used in other countries. DIN EN I

9、SO 11979-4 is part of a series of standards, under the general title Ophthalmic implants Intraocular lenses. The Bibliography in National Annex NA (informative) lists the other parts of the series that were valid as of the publication of this standard. Amendments This standard differs from DIN EN IS

10、O 11979-4:2009-03 as follows: a) the normative reference to ISO 11979-9:2006 has been deleted; b) in Table 2, further information for toric intraocular lenses has been included; c) in Clause 6, list item n) for multifocal intraocular lenses has been deleted. In consequence, list item o) has been ren

11、umbered as list item n) and list item p) as list item o); d) Clause 9 “Additional information” has been added; e) Amendment ISO 11979-4:2008/Amd.1:2012 (EN ISO 11979-4:2008/A1:2012) has been incorporated. Previous editions DIN EN ISO 11979-4: 2000-09, 2009-03 2DIN EN ISO 11979-4:2013-01 National Ann

12、ex NA (informative) Bibliography DIN EN 980, Symbols for use in the labelling of medical devices DIN EN 1041, Information supplied by the manufacturer of medical devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for mate-rials, sterile barrier syste

13、ms and packaging systems DIN EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes DIN EN ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary DIN EN ISO 11979-2, Ophthalmic implants Intraocul

14、ar lenses Part 2: Optical properties and test methods DIN EN ISO 11979-3, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods DIN EN ISO 11979-5, Ophthalmic implants Intraocular lenses Part 5: Biocompatibility DIN EN ISO 11979-6, Ophthalmic implants Intraocular lens

15、es Part 6: Shelf-life and transport stability DIN EN ISO 11979-7, Ophthalmic implants Intraocular lenses Part 7: Clinical investigations DIN EN ISO 11979-8, Ophthalmic implants Intraocular lenses Part 8: Fundamental requirements DIN EN ISO 11979-9, Ophthalmic implants Intraocular lenses Part 9: Mult

16、ifocal intraocular lenses DIN EN ISO 11979-10, Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements 3DIN EN ISO 11979-4:2013-0

17、1 This page is intentionally blank 4DIN EN ISO 11979-4:2013-01 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-4 December 2008 + A1 October 2012 ICS 11.040.70 English Version Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008 + Amd. 1:2012)

18、Implants ophtalmiques - Lentilles intraoculaires - Partie 4: tiquetage et informations (ISO 11979-4:2008 + Amd. 1:2012) Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2008 + Amd. 1:2012) EN ISO 11979-4:2008 was approved by CEN on 2008-11-29 and Amen

19、dment A1:2012 on 2012-08-29. 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 bibliographical references concerning such national s

20、tandards 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 responsibility of a CEN member into its own language an

21、d 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 of Macedonia, France, Germany, Greece, Hunga

22、ry, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by an

23、y means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-4:2008 + A1:2012 E EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 2DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 Contents Page Foreword to EN ISO 11979-4

24、2008 3 ! Foreword to EN ISO 11979-4:2008/A1:2012 . 4 Introduction . 5 1 Scope . 6 2 Normative references 6 3 Terms and definitions 6 4 Information provision 6 5 Labelling 6 6 Package insert 8 7 Self-adhesive label . 9 8 Use of symbols . 9 ! 9 Additional information . 9 Bibliography 10 Foreword to E

25、N ISO 11979-4:2008 This document (EN ISO 11979-4:2008) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” 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 sta

26、tus of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2009, and conflicting national standards shall be withdrawn at the latest by June 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject

27、of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11979-4:2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Sta

28、ndard: 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 the United Kingdom

29、 Endorsement notice The text of ISO 11979-4:2008 has been approved by CEN as EN ISO 11979-4:2008 without any modification. 3DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 !Foreword to EN ISO 11979-4:2008/A1:2012 This document (EN ISO 11979-4:2008/A1:2012) has been prepared by Techn

30、ical 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 Amendment to the European Standard EN ISO 11979:2008 shall be given the status of a national standard, either by publication of an i

31、dentical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. 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

32、responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

33、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 and the United Kingdom. Endorsement notice The text

34、of ISO 11979-4:2008/Amd 1:2012 has been approved by CEN as EN ISO 11979-4:2008/A1:2012 without any modification.“ 4DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 Introduction This part of ISO 11979 contains requirements and guidance for the labelling of intraocular lenses and the in

35、formation supplied with them. Labelling requirements for medical devices in general are given in EN 1041. However, in order to ensure correct and necessary information to the ophthalmic surgeon, some additional information is required for intraocular lenses. This information concerns technical and o

36、ptical data as well as information about materials used. 5DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 1 Scope This part of ISO 11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. NOTE This part of

37、 ISO 11979 attempts to harmonize the recognized labelling requirements for IOLs throughout the world. However, there might be additional national requirements. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only

38、 the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: Vocabulary ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and infor

39、mation to be supplied Part 1: General requirements EN 980, Symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1 apply. 4 Inf

40、ormation provision The general requirements for information provision provided with medical devices by manufacturers included in EN 1041 shall be taken into account. 5 Labelling Table 1 lists minimal information that shall be included with the labelling of IOLs and whereabouts on the packaging it sh

41、all be given. Table 2 lists information that shall be given in applicable cases. !Deleted text“ 6DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 Table 1 Information that shall be included with the packaging of IOLs Item Information Primary package a, b and/or additional wrapping(s) S

42、torage container bComments 1 Name or trade name of the manufacturer cX X The manufacturers logotype may be added. 2 Address of the manufacturer and country of manufacture X 3 Trade name and/or model designation of the product X X 4 Batch code or serial number X X Symbols may be used. 5 The word “STE

43、RILE” X X dSymbols may be used. 6 Method of sterilization X Symbols may be used. 7 The statement “Do not resterilize” X 8 The statement “For single use” X Symbols may be used. 9 Expiration date (year and month; format: YYYY MM) X Symbols may be used. 10 Dioptric power X X The unit is m1; in ocular o

44、ptics often denoted by the special symbol D. 11 Overall diameter, in millimetres X X May be indicated by the symbol or in a drawing. 12 Diameter (minimum and maximum dimensions, if non-circular) of the body, in millimetres X X May be indicated in a drawing. 13 Drawing depicting the configuration of

45、the lens X 14 Statement about intended placement X For instance: anterior chamber; posterior chamber; in the bag; etc. 15 Information aiding the surgeon to calculate the dioptric power to implant X Currently, there is no standardized methodology available. 16 Information on the recommended storage c

46、onditions for the lens X To be included where specific storage conditions are required. aThere are different systems in use with regard to primary container and additional wrapping(s). The information listed in the column is to be given on the appropriate component as to guarantee safe use and prope

47、r handling of the device. bIn ISO 11607-1 and ISO 11607-2 “primary package” is now “sterile barrier system”; “storage container” is now “protective packaging” . cSee definition of “manufacturer” in ISO 11979-1. dIf a statement about sterility is made on the storage container, it is to read “contains

48、 (number) sterile IOL(s)”, if the storagecontainer contains more than one IOL. 7DIN EN ISO 11979-4:2013-01 EN ISO 11979-4:2008-12 + A1: 2012-10 N1) National footnote: A “sterile barrier system” is a germ-tight protective packaging system that prevents the ingress of microorganisms, and “protective p

49、ackaging” is the physical protective packaging. N1) 6 Package insert The package insert, in the form of a leaflet or similar, shall be included in the storage container in such a way that it can be consulted without damage to the sterile packaging. It shall contain at least the following information. a) name or trade name and address of the manufacturer; b) detailed description of the lens including material(s) used; c) meth