EN ISO 15798-2013 en Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (Incorporates Amendment A1 2017)《眼科植入物 黏弹性眼科植入装置》.pdf

1、BSI Standards PublicationBS EN ISO 15798:2013Ophthalmic implants Ophthalmic viscosurgicaldevices (ISO 15798:2013)BS EN ISO 15798:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO15798:2013. It supersedes BS EN ISO 15798:2010 which is withdrawn.The UK part

2、icipation in its preparation was entrusted to TechnicalCommittee CH/172/7, Eye implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for i

3、ts correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 78874 1ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and S

4、trategy Committee on 30 September 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15798 September 2013 ICS 11.040.70 Supersedes EN ISO 15798:2010English Version Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)

5、Implants ophtalmiques - Dispositifs ophtalmiques viscolastiques (ISO 15798:2013) Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2013) This European Standard was approved by CEN on 2 April 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulat

6、e 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 standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Stan

7、dard 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 and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the nat

8、ional standards bodies of 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, Sl

9、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any me

10、ans reserved worldwide for CEN national Members. Ref. No. EN ISO 15798:2013: EBS EN ISO 15798:2013EN ISO 15798:2013 (E) 3 Foreword This document (EN ISO 15798:2013) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ in collaboration with Technical Committee CEN/TC 170 “Ophtha

11、lmic 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 or by endorsement, at the latest by March 2014, and conflicting national standards shall be withdrawn at the latest by March 2014.

12、 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. This document supersedes EN ISO 15798:2010. This document has been prepared under a m

13、andate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, th

14、e national standards organizations 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, Latvi

15、a, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 15798:2013 has been approved by CEN as EN ISO 15798:2013 without any modification. BS EN ISO 15798:2013EN

16、 ISO 15798:2013 (E) 4 Annex ZA (informative) Relationship between 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 mean

17、s of conforming to Essential Requirements of the New Approach Directive 93/42/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 claus

18、es of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/

19、EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5, 6.1, 6.2, 7 7.2 Reference to ISO 14971 for risk assessment. Reference to ISO 22442-1, ISO 22442-2, ISO 22442-3 for material of animal origin. Reference to ISO 10993-1 for testing of

20、 biological safety in general. Reference to ISO 10993-9, ISO 10993-16 for toxicokinetics of degradation products. Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO 13408-1 for aseptic processi

21、ng. Reference to ISO 11135-1 for sterilization with ethylene oxide. 6.2 7.3 6.1, 6.2, 7 7.5 Reference to ISO 22442-1, ISO 22442-2, ISO 22442-3 for material of animal origin. Reference to ISO 10993-1 for testing of biological safety in general. Reference to ISO 10993-9, ISO 10993-16 for toxicokinetic

22、s of degradation products. Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO 13408-1 for aseptic processing. Reference to ISO 11135-1 for sterilization with ethylene oxide. BS EN ISO 15798:201

23、3EN ISO 15798:2013 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 7 7.6 Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO

24、 13408-1 for aseptic processing. Reference to ISO 11135-1 for sterilization with ethylene oxide. 7 8.1 Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO 13408-1 for aseptic processing. Referen

25、ce to ISO 11135-1 for sterilization with ethylene oxide. 5, 6.1, 6.2 8.2 Reference to ISO 14971 for risk assessment. Reference to ISO 22442-1, ISO 22442-2, ISO 22442-3 for material of animal origin. Reference to ISO 10993-1 for testing of biological safety in general. Reference to ISO 10993-9, ISO 1

26、0993-16 for toxicokinetics of degradation products. 7, 8, 10 8.3 Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO 13408-1 for aseptic processing. Reference to ISO 11135-1 for sterilization wi

27、th ethylene oxide. Reference to ISO 11607-1 and ISO 14630 for packaging requirements. 7 8.4 Reference to ISO 17665-1 for sterilization by moist heat. Reference to ISO 11137-1, ISO 11137-2, ISO 11137-3 for sterilization by radiation. Reference to ISO 13408-1 for aseptic processing. Reference to ISO 1

28、1135-1 for sterilization with ethylene oxide. 11 8.7 9 9.1 5 9.2 Reference to ISO 14971 for risk assessment. Reference to ISO 22442-1, ISO 22442-2, ISO 22442-3 for material of animal origin. BS EN ISO 15798:2013EN ISO 15798:2013 (E) 6 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) o

29、f Directive 93/42/EEC Qualifying remarks/Notes 11 13 Ophthalmic viscosurgical devices (OVD) containing medicinal substances, or human blood derivatives, have not been considered in the standard, and at present no such products are known. Custom made OVD are not known. WARNING Other requirements and

30、other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15798:2013ISO 15798:2013(E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 24 Intended performance . 35 Design attributes

31、 45.1 General . 45.2 Characterization of the components 45.3 Characterization of the finished product . 46 Design evaluation 66.1 General . 66.2 Evaluation of biological safety . 66.3 Clinical evaluation 77 Sterilization . 98 Product stability 109 Integrity and performance of the delivery system .10

32、10 Packaging 1010.1 Protection from damage during storage and transport1010.2 Maintenance of sterility in transit . 1011 Information to be supplied by the manufacturer 10Annex A (normative) Intraocular implantation test .12Annex B (informative) Patient numbers for clinical investigation of intraocul

33、ar pressure 15Bibliography .16BS EN ISO 15798:2013ISO 15798:2013(E)ForewordISO (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

34、committees. Each member body interested in a subject for which a technical committee has been established 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 closely with

35、the International Electrotechnical Commission (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 Internati

36、onal Standards adopted 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

37、he subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 15798 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition

38、 (ISO 15798:2010), which has undergone minor revision to update the normative references and to revise Table 1.iv ISO 2013 All rights reservedBS EN ISO 15798:2013INTERNATIONAL STANDARD ISO 15798:2013(E)Ophthalmic implants Ophthalmic viscosurgical devices1 ScopeThis International Standard is applicab

39、le to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipula

40、te tissues during surgery.This International Standard specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.2

41、 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 10993-1, Biological evalu

42、ation of medical devices Part 1: Evaluation and testing within a risk management processISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirementsISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local effects after implantationISO 10993-9, Biolog

43、ical evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation productsISO 10993-16, Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachablesISO 11135-1, Sterilization of health care prod

44、ucts Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medi

45、cal devicesISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization doseISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspectsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements

46、for materials, sterile barrier systems and packaging systemsISO 13408-1, Aseptic processing of health care products Part 1: General requirementsISO 14155, Clinical investigation of medical devices for human subjects Good clinical practiceISO 14630, Non-active surgical implants General requirementsIS

47、O 14971, Medical devices Application of risk management to medical devicesISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements ISO 2013 All rights reserved 1BS EN ISO 15798:2013ISO 15798:2013(E)ISO 15223-2,

48、Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied Part 2: Symbol development, selection and validationISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a ste

49、rilization process for medical devicesISO 22442-1, Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk managementISO 22442-2, Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handlingISO 22442-3, Medical devices utilizing animal tissues and their derivatives Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agentsEN 980, Symbols for use in the