EN ISO 11979-4-2008 en Ophthalmic implants - Intraocular lenses - Part 4 Labelling and information (Incorporates Amendment A1 2012)《眼科植入物 眼内透镜 第4部分 标记和信息》.pdf

1、BS EN ISO11979-4:2008ICS11.040.70NOCOPYINGWITHOUTBSIPERMISSIONEXCEPTASPERMITTEDBY COPYRIGHTLAWBRITISH STANDARDOphthalmic implantsIntraocularlensesPart 4: Labelling and information (ISO11979-4:2008)+A1:2012National forewordThis British Standard is the UK implementation of EN ISO 11979-4:2008+A1:2012.

2、 It is identical to ISO 11979-4:2008, incorporating amendment 1:2012. It supersedes BS EN ISO 11979-4:2008 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. F

3、or example, text altered by ISO amendment 1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/172, Opthalmic optics, to Subcommittee CH/172/7, Eye implants.A list of organizations represented on this subcommittee can be obtained on request to its secr

4、etary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN ISO 11979-4:2008+A1:2012This British Standard waspublished under the

5、authority of the StandardsPolicy and StrategyCommittee on 28 February2009 The British Standards Institution 2012. Published by BSI Standards Limited 2012Amendments/corrigenda issued since publicationDate Comments 30 November 2012 Implementation of ISO amendment 1:2012 with CEN endorsement A1:2012.IS

6、BN 978 0 580 71468 9EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMICS 11.040.70English VersionOphthalmic implants - Intraocular lenses - Part 4: Labelling andinformation (ISO 11979-4:2008)Implants ophtalmiques - Lentilles intraoculaires - Partie 4:tiquetage et informations (ISO 11979-4:2008)Ophthal

7、mische Implantate - Intraokularlinsen - Teil 4:Etikettierung und Information (ISO 11979-4:2008)This European Standard was approved by CEN on 29 November 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the

8、status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German).

9、 A version in any other language made by translationunder 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 national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic

10、, 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 United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALI

11、SATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 11979-4:2008: EEN ISO 11979-4:2008+A1October 20123 Foreword This document (EN ISO 119

12、79-4:2008) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Technical Committee CEN/TC170 “Ophthalmic optics”, the secretariat of which is held by D IN.This European Standard shall be given the status of a national standard, either by publica

13、tion of an identical text or byendorsement, at the latest b y June 2009, and conflictingnationa l standards shall bewithdra wn atthe latest by June 2009.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

14、be held responsible for identifying any orall such patent rights. This document supersedes EN ISO 11979-4:2000.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

15、Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, S lovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement noticeThe text of ISO 1

16、1979-4:2008 has been approved by CEN as a EN ISO 11979-4:2008 without anymodification.Foreword to amendment A1 This document (EN ISO 11979-4:2008/A1:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optic

17、s” 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 identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at

18、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 responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the natio

19、nal standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lith

20、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-4:2008/Amd 1:2012 has been approved by CEN as a EN ISO 11979-4:2008/A1:2012 without any modification. BS E

21、N ISO 11979-4:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E) ISO 20 iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical

22、committees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the

23、 International Electrotechnical Com mission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft Internatio

24、na l Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be t

25、he subject of patent rights. ISO shall not be held responsible for identifying an y or all such patent rights. ISO 11979-4 was prepared by Technical Committee ISO/TC 172, Optics and photonics , Subcommittee SC 7, Ophthalmic optics and instruments . This second edition cancels and replaces the first

26、edition (ISO 11979-4:2000), which has been technically revised.ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and testmethods Part3: Mechanical properties and testmethods Part 4: Labelling and i

27、nformation Part 5: Biocompatibility Part 6: Shelf-life and transport stability Part 7: Clinical investigations Part 8: Fundamental requirements Part 9:Multifocal intraocular lenses Part10: Phakic intraocularlenses12BS EN ISO 11979-4:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E)iv ISO 2012Introduction Th

28、is part of ISO 11979 contains re quirements and guidance for the labelling of intraocular lenses and th einformation supplied with them. Labelling requirements for medical devices in general are given in EN 1041. However, in order to ensurecorrect and necessary info rmation to the ophthalmic surgeon

29、, some additional information is required forintraocular lenses. This information c oncerns technical and optical data as well as information about materials used. BS EN ISO 11979-4:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E)INTERNATIONAL STANDA RD ISO 2012 1Ophthalmic implants Intraocular lenses Part

30、 4: Labelling and information 1 Scope This part of ISO11979 specifies the labelling requirements for intraocular lenses (IOLs) and the information tobe provided within or on the packaging. NOTE This part of ISO 11979 attempts to harmonize the recognized labelling requirements for IOLs throughout the

31、world. However, there might be additional national requirements. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (

32、including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 15223-1, Medical devices Symbols to beused with medical devicelabels, labelling and informationtobe supplied Part 1: General requirementsEN 980, Symbols for use in the labelling of medical dev

33、icesEN 1041, Information supplied by the manufacturer with medical devices3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 11979-1 apply.4 Information provision The general requirements for information provision provided with medical devices by manufa

34、cturers 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 shall be given. Table 2 lists information that shall be given in applicable cases.!Text deleted“BS EN ISO 11979

35、-4:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E)2 ISO 2012Table 1 Information that shall be incl uded with the packaging of IOLsItem Information Primary package a, b and/or additional wrapping(s) Storage container b Comments 1 Name or trade name of the manufacturer cXXThe manufacturers logotype may bead

36、ded. 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 XXSymbols may be used. 5 The word “STERILE” d Symbols may be used. 6 Method of sterilization XSymbols may be used. 7 The statement “Do not resteriliz

37、e” X 8 The statement “For single use” XSymbols may be used. 9 Expiration date (year and month; format: YYYY MM)XSymbols may be used. 10 Dioptric power XXThe unit is m 1 ; in ocular optics oftendenoted by the special symbol D.11 Overall diameter, inmillimetres X X May be indicated by the symbol or in

38、a drawing. 12 Diameter (minimum and maximum dimensions, if non-circular) of the body, in millimetres XXMay be indicated in a drawing.13 Drawing depicting the configuration of the lensX 14 Statement about intended placement XFor instance: anterior chamber;posterior chamber; in the bag; etc. 15 Inform

39、ation aiding the surgeonto calculate the dioptric power to implant XCurrently, there is no standardizedmethodology available. 16 Information on therecommended storage conditions for the lens XTo be included where specific storage conditions are required. a There are different systems in use with reg

40、ard to primary container and additional wrapping(s). The information listed in the columnis to be given on the appropriatecomponent asto guarantee safe use and proper handling of the device.b In ISO 11607-1 and ISO11607-2 “primary package” is now “sterile barrier system”; “storage container” is now

41、“protectivepackaging”.c See definition of “manufacturer” in ISO 11979-1.d If a statement about sterility ismade on thestorage container, it isto read “contains (number) sterile IOL(s)”, if thestor age container contains more than one IOL.BS EN ISO 11979-4:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E) IS

42、O 20 3Table 2 Information that shall be included with the packagingof IOLs in applicable cases Item Information Primary package and/or additional wrapping(s) Storage container Comments 17 Additional descriptions the manufacturer wishes to provide XFor instance: about optic shape, typeand material; h

43、aptic type and material;UV-absorber; foldable; etc. 18 Statement “Custom madedevice” X 19 Statement “Exclusively for clinical investigation” X 20 For multifocal intraocular lenses: base power and add power(s) X 6 Package insertThe package insert, in the form of a leaflet or similar, shall be include

44、d in the storage container in such a waythat 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) method of sterilizat

45、ion; d) conditions of storage and transport (if appropriate);e) instructions for the removal of the IOL from the primary container; f) instructions for use; NOTEEuropean Directive 93/42/EEC as amended by Directive 2007/47/EC requires date of issue or the latestrevision of the instructions for use fo

46、r medical devices sold in Europe. g) indication(s) of the circumstances under which the IOL can be used; h) contra-indication(s) of the circumstances under which the IOL should not be used;i) complication(s) that may occur;j) warning not to implant the IOL if the container which maintains sterility

47、has been opened or damaged; k) warning not to re-use the IOL; l) warning not to re-sterilize the IOL; m) formultifocal and phakic intraocular lenses, a summary of the results of the clinical investigation, if any;!Text deleted“21 For toric intraocular lenses only:the spherical equivalent powerx Addi

48、tionally sphere, cylinder and axis (in + or cylinder notation) may be given.22For toric intraocular lenses only:the orientation of the meridian ofx (SE) and the absolute cylinder power (CYL).lowest positive power or most negative power depicted in the lens drawing (see item 13).!“12BS EN ISO 11979-4

49、:2008+A1:2012 ISO 11979-4:2008+A1:2012 (E)x4 ISO 2008for phakic intraocular lenses, recommendations for periodic evaluations after implantation, based on riskanalysis and/or any clinical inv estigation performed, and a restr iction in the indications for use if necessitated by the anatomical clearance analysis and clinical evaluation; 7 Self-adhesivelabel If supplied, a self-adhesive label shall contain at least the following information. a) name or trade name of the manufacturer;b) trade name and/or model designation of the product