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

1、BSI Standards PublicationBS EN ISO 16672:2015Ophthalmic implants Ocular endotamponades (ISO16672:2015)BS EN ISO 16672:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16672:2015. It supersedes BS EN ISO 16672:2003 which is withdrawn.The UK participation i

2、n 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 its correcta

3、pplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 85354 8ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Com

4、mittee on 31 August 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD 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 - Prod

5、uits de tamponnement endoculaires (ISO 16672:2015) Ophthalmische Implantate - Okulare Endotamponaden (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 Eur

6、opean 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 Standard exists in three official versio

7、ns (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 national standards bodies of Austria, B

8、elgium, 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, Slovenia, Spain, Sweden, Swi

9、tzerland, 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 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN natio

10、nal Members. Ref. No. EN ISO 16672:2015 EBS EN ISO 16672:2015EN ISO 16672:2015 (E) 3 European 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

11、 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 February 2016, and conflicting national standards shall be withdrawn at the latest by February 2016. Attention is drawn to

12、 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 16672:2003. This document has been prepared under a mandate given to CEN by

13、 the European Commission and the European 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 applicat

14、ion of this document. For undated references, 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

15、 document has not been superseded and 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

16、 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 normative requirements determines the extent (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO stand

17、ards 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:2010 ISO 10993-1:2009 + Cor 1:2010 ISO 10993-2:2006 EN ISO 10993-2:2006 ISO 10993-2:2006 ISO 11607-1:2006 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + Am

18、d 1:2014 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 15223-1:2012 EN ISO 15223-1:20

19、12 ISO 15223-1:2012 ISO 22442-1:2007 EN ISO 22442-1:2007 ISO 22442-1:2007 EN 1041:2008 + A1:2013 EN 1041:2008 + A1:2013 BS EN ISO 16672:2015EN ISO 16672:2015 (E) 4 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implemen

20、t 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, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Sl

21、ovakia, Slovenia, 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. BS EN ISO 16672:2015EN ISO 16672:2015 (E) 5 Annex ZA (informative) Relationship between this European Sta

22、ndard 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/EEC on medical dev

23、ices. 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 of the scope of thi

24、s 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 compliance with Directiv

25、e 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 determining acceptable risk m

26、ust 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 Essential Requirement does

27、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 remarks/notes 5.2 b)

28、 potential interactions of the OE with other materials likely to be used in ophthalmic surgery;c) for intraocular gases, any impurity profile changes as the gas is depleted from the tank.NOTE Impurity profile changes can occur as the concentration of the chemical species changes due to the differenc

29、es in vapour pressure as the tank is depleted.The OE shall be evaluated to demonstrate that the intended performance is achieved. The requirements for evaluation of non-active implants specified in ISO 14630 shall apply.6.2 Evaluation of biological safety6.2.1 GeneralThe relevant biocompatibility en

30、d points specified in ISO 10993-1 and identified by the risk analysis shall be taken into account when selecting the tests to evaluate the biological safety of an OE.NOTE Based upon the typical clinical applications in the posterior segment, OE are categorized as “Implant devices, tissue/bone”. The

31、tests for this and other categories of devices identified in Table 1 of ISO 10993-1:2009 are for guidance only; they do not represent maximum or minimum test requirements.6.2.2 Bacterial endotoxins testWhere applicable, the OE shall be evaluated for the presence of bacterial endotoxins using the Lim

32、ulus Amoebocyte Lysate (LAL) test, in accordance applicable pharmacopoeias or an equivalent validated test procedure. Any product that exceeds a bacterial endotoxin limit of 0,5 Endotoxin Units (EU) per ml fails the test.6.2.3 Intraocular implantation testTests for intraocular irritation, inflammati

33、on, intraocular pressure (IOP) and other local effects of the OE shall be conducted in a suitable animal model, in accordance with animal welfare requirements specified in ISO 10993-2 or following any local legislation. ISO 2015 All rights reserved 5BS EN ISO 16672:2015ISO 16672:2015(E)Due to differ

34、ences between the vascularised human retina and the avascular rabbit retina especially for non-aqueous substances a suitable animal model has to be validated.The particular requirements for this intraocular implantation test are specified in Annex A.The study design shall mirror the intended clinica

35、l use as closely as possible.The study design should assess the intra-operative and postoperative intraocular irritation, inflammation, and local effects of the ophthalmic surgery with comparative use of the OE under evaluation and a control OE which has already been proven in clinical use to be acc

36、eptable. The volume of OE used should simulate the intended use, accounting for ocular volume differences between the human and animal models.The post-surgical irritation, inflammation, and local effects shall be monitored and graded at intervals appropriate to the duration of the intended use. All

37、adverse events shall be documented.The OE shall show intraocular irritation, inflammation and local effects results comparable to or less than a control OE of the same intended use. Intraocular irritation, inflammation and local effects in excess of the control OE are acceptable if justified by the

38、risk benefit analysis.NOTE It may be possible to combine biocompatibility tests, thereby reducing the number of animals required for testing. Two tests can be conducted simultaneously in a single animal provided that the test animals are not subjected to undue pain or distress.6.2.4 Ethylene oxideIf

39、 ethylene oxide (EO) is used during the manufacturing of ingredients or in justified sterilization of the packaging, the total level of EO in the product shall not exceed 20 g/g for EO and 100 g/g for ethylene chlorohydrin (ECH).6.3 Clinical investigationA preclinical evaluation and risk assessment

40、shall be performed to determine if a clinical investigation is needed. If so, Annex B shall be considered. In addition, the general requirements concerning the clinical investigations of medical devices for human subjects specified in ISO 14155 shall apply.7 SterilizationWherever possible, the produ

41、ct shall be terminally sterilized in its final container. The requirements for sterilization of non-active surgical implants specified in ISO 14630 shall apply and an appropriate standard for the method of sterilization shall be applied.Ethylene oxide shall not be used unless there is documented jus

42、tification for its use.NOTE 1 The following standards for sterilization are currently valid: for products, or components thereof, sterilized by moist heat: ISO 17665-1; for products, or components thereof, sterilized by dry heat: ISO 20857; for products, or components thereof, sterilized by radiatio

43、n: ISO 11137-1; for products, or components thereof, sterilized by ethylene oxide: ISO 11135-1.6 ISO 2015 All rights reservedBS EN ISO 16672:2015ISO 16672:2015(E)If a product cannot be terminally sterilized, aseptic processing is an accepted alternative. For such products, the requirements specified

44、 in ISO 13408-1 shall apply. Compliance with this International Standard shall be demonstrated by a validated media fill study with a contamination rate limit of 103.NOTE 2 ISO 134081 specifies the general requirements for and offers guidance on processes, programmes and procedures for the validatio

45、n and control of aseptically processed healthcare products. It particularly applies to, but is not limited to, the processing of aqueous solutions, and is thus relevant to the preparation of OE. Future parts of this International Standard will address specialized processes, such as filtration and ly

46、ophilization.8 Product stabilityThe manufacturer shall define and state the shelf-life of the product and its delivery system. Real time or validated accelerated shelf-life testing shall be performed to demonstrate that the essential characteristics for safe and effective performance of the finished

47、 product and delivery system do not change over the labelled shelf-life under expected conditions of transport and storage. The temperature used in accelerated testing shall not exceed 45 C. The parameters that shall be followed during shelf-life studies are those factors identified by the risk anal

48、ysis as being crucial to the safe use of the product.Changes in the composition of the product, source materials, material suppliers, manufacturing conditions, including the sterilization process, package design or package materials, can affect the shelf-life of the product.The established shelf-lif

49、e of the OE shall be re-validated if a risk assessment identifies any change in manufacture that can affect the stability of the product.9 Integrity and performance of the delivery systemChemical and physical compatibility of the OE and the delivery system shall be evaluated and documented.Appropriate testing should be conducted to demonstrate that mechanical failure of the delivery system will not result from use as intended.10 Packaging10.1 Protection from damage during storage and transportThe packaging requirements for medical devices specifie