EN ISO 16671-2015 en Ophthalmic implants - Irrigating solutions for ophthalmic surgery (Incorporates Amendment A1 2017)《眼科植入物 眼外手术用冲洗溶液（ISO 16671 2015）》.pdf

1、BSI Standards PublicationBS EN ISO 16671:2015Ophthalmic implants Irrigating solutions forophthalmic surgery (ISO16671:2015)BS EN ISO 16671:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO16671:2015. It supersedes BS EN ISO 16671:2003 which is withdrawn.T

2、he UK participation 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 respons

3、ible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 85355 5ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Po

4、licy and Strategy Committee on 31 August 2015.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 16671 August 2015 ICS 11.040.70 Supersedes EN ISO 16671:2003English Version Ophthalmic implants - Irrigating solutions for ophthalmic surgery (I

5、SO 16671:2015) Implants ophtalmiques - Solutions dirrigation pour la chirurgie ophtalmique (ISO 16671:2015) Ophthalmische Implantate - Spllsungen fr die ophthalmische Chirurgie (ISO 16671:2015) This European Standard was approved by CEN on 7 May 2015. CEN members are bound to comply with the CEN/CEN

6、ELEC 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 standards may be obtained on application to the CEN-CENELEC Management Centre

7、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 and notified to the CEN-CENELEC Management Centre has the same status as the of

8、ficial 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherland

9、s, Norway, Poland, Portugal, Romania, Slovakia, 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 2015 CEN All rights o

10、f exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 16671:2015 EBS EN ISO 16671:2015EN ISO 16671:2015 (E) 3 European foreword This document (EN ISO 16671:2015) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collabora

11、tion with Technical Committee CEN/TC 170 “Ophthalmic 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 February 2016, and conflicting national standa

12、rds shall be withdrawn at the latest by February 2016. 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

13、 16671:2003. This document has been prepared under a mandate given to CEN by 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 doc

14、ument. The following referenced documents are indispensable for the application 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 with

15、in the meaning of Annex ZA, the user should always check that any referenced 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

16、as a normative reference to the corresponding EN standard, if available, and 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 appl

17、y. Table Correlation between normative references and dated EN and ISO standards 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

18、-2:2006 ISO 11607-1:2006 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + Amd 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 14

19、971:2007 EN ISO 14971:2012 ISO 14971:2007 ISO 15223-1:2012 EN ISO 15223-1:2012 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 16671:2015EN ISO 16671:2015 (E) 4 According to the CEN-CENELEC Internal Regulations, the natio

20、nal 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, Latvia, Lith

21、uania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 16671:2015 has been approved by CEN as EN ISO 16671:2015 without any modification. BS EN ISO 16671:2015EN ISO 16

22、671:2015 (E) 5 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 means of co

23、nforming to the Essential Requirements of 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 normative clauses of this

24、 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. NOTE 1 Where a reference from a clause of this standard to the risk management process

25、is made, the risk management process needs to be in compliance with Directive 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 re

26、quirement. NOTE 2 The manufacturers policy for determining acceptable risk must 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

27、 the references in the core text. NOTE 4 When an Essential Requirement does 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 Essenti

28、al Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/notes 5.4.3 not more than 5 particles equal to or greater than 25 m per ml of OIS; not more than 2 particles equal to or greater than 50 m per ml of OIS.The following limits shall apply for the microscopic test method of Annex D: not mo

29、re than 25 particles equal to or greater than 10 m per ml of OIS; not more than 2,5 particles equal to or greater than 25 m per ml of OIS; not more than 1 particle equal to or greater than 50 m per ml of OIS.4 ISO 2015 All rights reservedBS EN ISO 16671:2015ISO 16671:2015(E)NOTE The light obscuratio

30、n test method of Annex C is based on light blockage. Amorphous, semi-liquid or otherwise morphologically indistinct materials contribute to light obscuration and therefore contribute to the particle count. In the microscopic test method of Annex D, amorphous, semi-liquid or otherwise morphologically

31、 indistinct materials appear as stain or discolouration on the surface of the membrane filter, and are not counted as particles. To compensate for this difference, the limits for the microscopic test method are one half those for the light obscuration method.6 Design evaluation6.1 GeneralThe OIS sha

32、ll be evaluated to demonstrate that the intended performance is achieved. The requirements for evaluation of non-active implants outlined in ISO 14630 shall apply.6.2 Preclinical evaluation of biological safety6.2.1 GeneralThe procedure for evaluation of biological safety of an OIS shall commence wi

33、th an assessment of risk, carried out and documented in accordance with ISO 14971. The results of the risk analysis shall determine the tests required to evaluate the biological safety of the OIS.For OIS containing material of animal origin the risk analysis and management requirements outlined in I

34、SO 22442-1 shall apply.During the risk assessment the manufacturer should take into account the interaction with other ophthalmic products.For all OIS the requirements for evaluation of biological safety specified in ISO 10993-1 shall apply.NOTE 1 Based upon the typical clinical applications, OIS ar

35、e categorized as “Implant devices, tissue/bone”. The tests for this and other categories of devices identified in ISO 10993-1:2009, Table A.1, are for guidance only. They do not represent maximum or minimum test requirements.NOTE 2 It might be possible to combine biocompatibility tests, thereby redu

36、cing the number of animals required for testing. Multiple tests can be conducted simultaneously in a single animal provided that the test animal is not subjected to undue pain or distress.In addition to the biocompatibility tests identified in ISO 10993-1 and by the risk analysis, all of the followi

37、ng tests shall be considered in the selection of tests to evaluate the biological safety of an OIS.6.2.2 Bacterial endotoxins testThe OIS shall be evaluated for the presence of bacterial endotoxins using the Limulus Amoebocyte Lysate (LAL) test, in accordance with applicable pharmacopoeias or an equ

38、ivalent 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 irritation and inflammationIf the risk assessment indicates that it is necessary to undertake tests for intraocular irritation, inflammation, int

39、raocular pressure and other local events, such tests shall be conducted in a suitable animal model in accordance with Annex E. The choice of animal species shall be justified and documented. The animal welfare requirements as described in ISO 10993-2 shall apply.The animal testing shall mirror the i

40、ntended clinical use as closely as possible.The study design should assess the intraoperative and postoperative ocular irritation and inflammation of the ophthalmic surgery, with comparative use of the OIS under evaluation and a control OIS that has already been proven to be non-irritating and non-i

41、nflammatory in clinical use for five years. The ISO 2015 All rights reserved 5BS EN ISO 16671:2015ISO 16671:2015(E)volume of OIS used shall simulate the intended use, accounting for ocular volume differences between the human eye and that of the animal model.The post-surgical irritation and inflamma

42、tion shall be monitored and graded in accordance with Annex E. Based upon the risk management plan, appropriate evaluation at appropriate times can include corneal pachymetry and slit lamp bio microscopy. All adverse effects shall be documented.The OIS shall show ocular irritation and inflammation r

43、esults less than or equal to the control OIS, or it shall be excluded from clinical use.6.3 Clinical evaluationIf clinical evaluation and risk assessment identify the need for a clinical investigation, Annex F shall be considered. In addition, the general requirements concerning clinical investigati

44、ons of medical devices for human subjects specified in ISO 14155 shall apply.7 SterilizationWhenever possible, the product shall be terminally sterilized in its final container. The requirements for sterilization of non-active surgical implants outlined in ISO 14630 shall apply.Ethylene oxide shall

45、not be used to sterilize the OIS solution and, unless justified, not to sterilize the primary container either. In case of justification and use for the latter, ethylene oxide and related contaminants can diffuse into the solution, for which the following limits shall then apply: ethylene oxide: les

46、s than 20 g/ml ethylene chlorohydrin: less than 100 g/mlNOTE 1 It has been found that the requirements determining acceptable limits for ethylene oxide residuals specified in ISO 10993-7 are inadequate for devices in contact with highly sensitive tissues, such as those of the eye. For this case AAMI

47、 TIR No. 19 provides additional guidance to the application of ISO 10993-7.For OIS that are not terminally sterilized, but aseptically processed, ISO 13408-1 shall apply. The process shall be demonstrated to comply with a contamination rate limit of 103by a validated media fill study.NOTE 2 ISO 1340

48、8-1 specifies the general requirements for, and offers guidance on, processes, programmes, and procedures for the validation and control of aseptically processed healthcare products. ISO 13408-1 particularly applies, but is not limited to, the processing of aqueous solutions, and is thus relevant to

49、 the preparation of OIS. Future parts of that International Standard will address specialized processes, such as filtration and lyophilisation.8 Product stabilityThe manufacturer shall define and state the shelf-life of the product. Real time or accelerated shelf-life testing shall be performed to demonstrate that the finished product remains within specifications for a period of the labelled shelf-life under expected conditions of transport and storage. Real time testing shall reflect normal storage temperature and temperature fluctua