1、BS EN ISO15004-1:2009ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Fundamentalrequirements and testmethodsPart 1: General requirementsapplicable to all ophthalmicinstruments (ISO 15004-1:2006)This British Standard was publish
2、ed under theauthority of the StandardsPolicy and StrategyCommittee on 31 July2009 BSI 2009ISBN 978 0 580 65436 7Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15004-1:2009National forewordThis British Standard is the UK implementation of EN ISO15004-1:2009. It is identical to I
3、SO 15004-1:2006. It supersedes BS ENISO 15004-1:2006 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does
4、not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15004-1April 2009ICS 11.040.70 Supersedes EN ISO 1
5、5004-1:2006 English VersionOphthalmic instruments - Fundamental requirements and testmethods - Part 1: General requirements applicable to allophthalmic instruments (ISO 15004-1:2006)Instruments ophtalmiques - Exigences fondamentales etmthodes dessai - Partie 1: Exigences gnralesapplicables tous les
6、instruments ophtalmiques (ISO15004-1:2006)Ophthalmische Instrumente - Grundlegende Anforderungenund Prfverfahren - Teil 1: Allgemeine Anforderungen anophthalmische Instrumente (ISO 15004-1:2006)This European Standard was approved by CEN on 7 March 2009.CEN members are bound to comply with the CEN/CE
7、NELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the 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
8、 CEN member.This European Standard exists in three official versions (English, French, German). 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
9、members are the national standards bodies of 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
10、, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No.
11、 EN ISO 15004-1:2009: EBS EN ISO 15004-1:2009EN ISO 15004-1:2009 (E) 3 Foreword The text of ISO 15004-1:2006 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 15004-1:2009
12、 by 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 October 2009, and conflicting national standards sha
13、ll be withdrawn at the latest by March 2010. 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 15004-1:2
14、006. 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 93/42/EEC, as amended by Directive 2007/47/EC. For relationship with EU Directive 93/42/EEC as amended by Directiv
15、e 2007/47/EC, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, De
16、nmark, 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. Endorsement notice The text of ISO 15004-1:2006 has been ap
17、proved by CEN as a EN ISO 15004-1:2009 without any modification. BS EN ISO 15004-1:2009EN ISO 15004-1:2009 (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
18、to CEN by the European Commission and the European Free Trade Association to provide a means 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 Communities under that Directive and ha
19、s been implemented as a national standard in at least one Member State, compliance with the clauses 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 associate
20、d EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All clauses 1, 2, 3, 4, 5, 6 Testing according to clause 7. 6 a) This relevant Essentia
21、l Requirement is not addressed in EN ISO 15004-1. This requirement will be addressed by the manu-facturers risk management process. See EN ISO 14971 for risk management and EN ISO 14155-1 and -2 for clinical investigation. 4.1 1, 2, 3, 4, 5, 6 4.2 1, 2, 7.5 4.3 3 4.4 9.14.5 7.1 4.6 8.14.7 10.1, 10.2
22、4.8 12.7.5 Testing according to clause 7.2. 4.9 9.2, 12.7.1 5.1 4, 9.2 Testing according to clause 7. 5.2 5, 9.2 Testing according to clause 7. 5.3 5, 9.2 6.1 12.6, 12.7.46.3 11.1, 11.2, 11.3, 11.4 In the previous edition (EN ISO 15004:1997) the relevant requirements and test methods were directly i
23、ncorporated in the standard. In the present revised edition, these requirements and test methods have been referred to ISO 15004-2, and they are hence now incorporated in the present standard by means of a normative reference to BS EN ISO 15004-1:2009EN ISO 15004-1:2009 (E) 5 Clause(s)/sub-clause(s)
24、 of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes EN ISO 15004-2. 8.1 13.1, 13.6 Essential Requirement 13.6 is only partly addressed in EN ISO 15004-1: Essential Requirement 13.6 g) relating to instructions in the event of damage to the sterile packaging and to
25、 appropriate methods of re-sterilization is not addressed. 8.2 13.3 This relevant Essential Requirement is only partly addressed in EN ISO 15004-1: Essential Requirement 13.3 a) relating to authorized representative is not addressed. 12.1 a) This relevant Essential Requirement is not addressed in EN
26、 ISO 15004-1. This requirement can be addressed by application of other standards, e.g. IEC 60601-1-4, IEC 62304. WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 15004-1:2009ISO 15004-1:2006(E) ISO 2006 All r
27、ights reserved iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 Fundamental requirements (for non-active and active ophthalmic instruments) 2 4.1 General. 2 4.2 Design 2 4.3 Performance 2 4.4 Combination of different devices 2 4.5 Materials 3 4.6 Prote
28、ction against contaminants 3 4.7 Scales and displays 3 4.8 Thermal hazards . 3 4.9 Mechanical hazards 3 5 Environmental conditions (for non-active and active ophthalmic instruments) 3 5.1 Environmental conditions of use 3 5.2 Storage conditions . 4 5.3 Transport conditions 4 6 Particular requirement
29、s for active ophthalmic instruments 5 6.1 Electrical safety. 5 6.2 Inapplicable clauses of IEC 60601-1:2005 5 6.3 Optical radiation hazard. 5 7 Test methods. 5 7.1 Ignitability 5 7.2 Surface temperatures. 5 7.3 Environmental conditions 5 7.4 Checking electrical safety 7 8 Information supplied by the
30、 manufacturer 7 8.1 Accompanying documents 7 8.2 Marking 7 Annex A (informative) Product-related International Standards for ophthalmic instruments . 8 BS EN ISO 15004-1:2009ISO 15004-1:2006(E) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) is a worl
31、dwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on
32、that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted i
33、n accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard
34、 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 the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15004-1 was prepared by
35、Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This first edition together with ISO 15004-2 cancels and replaces ISO 15004:1997, which has been technically revised as follows: a) all reference to light hazard (definitions 3.4 to 3.9, 6.3,
36、7.5, Annexes A, C and D of ISO 15004:1997) has essentially been moved to ISO 15004-2; b) ignitability requirement/testing changed (4.5.2 and 7.1 of ISO 15004:1997); c) environmental requirements/testing partly changed Table 1; 5.2.2 and 8.1 f) of ISO 15004:1997; d) normative Annex B (now informative
37、 Annex A) entirely updated; e) normative (dated) reference updated to use IEC 60601-1:2005 edition. ISO 15004 consists of the following parts, under the general title Ophthalmic instruments Fundamental requirements and test methods: Part 1: General requirements applicable to all ophthalmic instrumen
38、ts Part 2: Light hazard protection BS EN ISO 15004-1:2009INTERNATIONAL STANDARD ISO 15004-1:2006(E) ISO 2006 All rights reserved 1Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments 1 Scope This part of ISO 15004 spec
39、ifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This part of ISO 15004 is not appli
40、cable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated r
41、eferences, the latest edition of the referenced document (including any amendments) applies. ISO 9022-2:2002, Optics and optical instruments Environmental test methods Part 2: Cold, heat and humidity ISO 9022-3:1998, Optics and optical instruments Environmental test methods Part 3: Mechanical stress
42、 ISO 15004-2:1), Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-1:1992, Medical electrical equipment Part 1-1: General
43、requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 60695-2-10:2000, Fire hazard testing Part 2-10: Glowing/hot-wire based test methods Glow-wire apparatus and common test procedure IEC 60695-2-11:2000, Fire hazard testing Part 2-11: Glowing/hot-wire b
44、ased test methods Glow-wire flammability test method for end-products 1) To be published. (Revision of ISO 15004:1997) BS EN ISO 15004-1:2009ISO 15004-1:2006(E) 2 ISO 2006 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 oph
45、thalmic instrument device designed to have an application to the eye 3.2 non-invasive ophthalmic instrument ophthalmic instrument which does not in whole or in part penetrate inside the body, either through a body orifice or through the surface of the body 3.3 active ophthalmic instrument any ophtha
46、lmic instrument that depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and that acts by converting this energy NOTE Ophthalmic devices intended to transmit energy, substances or other elements between an active ophthalmic
47、instrument and the patient, without any significant change, are not considered to be an active ophthalmic instrument. 3.4 manufacturer ophthalmic instrument natural or legal person who places the ophthalmic instrument on the market 4 Fundamental requirements (for non-active and active ophthalmic ins
48、truments) 4.1 General This part of ISO 15004 takes precedence over the corresponding requirements of IEC 60601-1:2005 and IEC 60601-1-1:1992, if differences exist. The general requirements specified in this part of ISO 15004 for ophthalmic instruments shall be applied in conjunction with those of th
49、e relevant product-related International Standard, if it exists. Annex A provides for information the list of relevant product-related International Standards. 4.2 Design Ophthalmic instruments shall be so designed that, when used for the performance of the intended function(s) in accordance with instructions provided by the manufacturer, the risks associated with such use are reduced to a level compatible with the generally acknowledged state of the art. 4.3 Performance The ophthalmic instrument shall achiev
