DIN EN ISO 15004-1-2009 Ophthalmic instruments - Fundamental requirements and test methods - Part 1 General requirements applicable to all ophthalmic instruments (ISO 15004-1 2006).pdf

1、July 2009DEUTSCHE NORM English price group 11No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.70!$XY“1535425www.

2、din.deDDIN EN ISO 15004-1Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments(ISO 15004-1:2006)English version of DIN EN ISO 15004-1:2009-07Ophthalmische Instrumente Grundlegende Anforderungen und Prfverfahren Teil 1:

3、Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2006)Englische Fassung DIN EN ISO 15004-1:2009-07SupersedesDIN EN ISO 15004-1:2006-09See start of validitywww.beuth.deDocument comprises 17 pagesDIN EN ISO 15004-1:2009-07 2 Start of validity This standard takes effect on 1 July 2009

4、. DIN EN ISO 15004-1:2006-09 may be used in parallel until 21 March 2010. National foreword This standard includes safety requirements. This standard has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in cooperation with Technical Committee CEN/TC 170 “Ophthalmic op

5、tics” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee), Technical Committee NA 027-01-08 AA Augenoptik, Working Group AK Ophthalmische Instrumente. This standard co

6、ntains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. The DIN Standards corresponding to the International Standards (ISO and IEC) referred to in clause 2 of the EN are as follows: ISO 9022-2 DIN ISO 9022-2 ISO 9022-3 DIN ISO 9022-3 ISO 15004-

7、2 DIN EN ISO 15004-2 IEC 60601-1 DIN EN 60601-1 IEC 60601-1-1 DIN EN 60601-1-1 IEC 60695-2-10 DIN EN 60695-2-10 IEC 60695-2-11 DIN EN 60695-2-11 Amendments This standard differs from DIN EN ISO 15004-1:2006-09 as follows: a) The informative Annex ZA “Relationship between this European Standard and t

8、he Essential Requirements of EU Directive 93/42/EEC” has been updated on the basis of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medi

9、cal devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. b) The revised EN ISO Standard has been adopted. Previous editions DIN EN ISO 15004: 1998-04 DIN EN ISO 15004-1: 2006-09 DIN EN ISO 15004-1:2009-07 3 N

10、ational Annex NA (informative) Bibliography DIN ISO 9022-2, Optics and optical instruments Environmental test methods Part 2: Cold, heat and humidity DIN ISO 9022-3, Optics and optical instruments Environmental test methods Part 3: Mechanical stress DIN EN ISO 15004-2, Ophthalmic instruments Fundame

11、ntal requirements and test methods Part 2: Light hazard protection DIN EN 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-1, Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety

12、 requirements for medical electrical systems DIN EN 60695-2-10, Fire hazard testing Part 2-10: Glowing/hot-wire based test methods Glow-wire apparatus and common test procedure DIN EN 60695-2-11, Fire hazard testing Part 2-11: Glowing/hot-wire based test methods Glow-wire flammability test method fo

13、r end-products DIN EN ISO 15004-1:2009-07 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15004-1April 2009ICS 11.040.70 Supersedes EN ISO 15004-1:2006 English VersionOphthalmic instruments - Fundamental requirements and testmethods - Part 1: General requirem

14、ents applicable to allophthalmic instruments (ISO 15004-1:2006)Instruments ophtalmiques - Exigences fondamentales etmthodes dessai - Partie 1: Exigences gnralesapplicables tous les instruments ophtalmiques (ISO15004-1:2006)Ophthalmische Instrumente - Grundlegende Anforderungenund Prfverfahren - Teil

15、 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/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national sta

16、ndard 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). A version in any other

17、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, Denmark, Estonia, Finl

18、and,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 NORMALISATIONEUROPISCHES KOMITE

19、E 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. EN ISO 15004-1:2009: EContents Page 4 5 6 6.3 Annex ZA (informative) Relationship between this European Standard and t

20、he Essential EN ISO 15004-1:2009 (E) DIN EN ISO 15004-1:2009-07 21 Scope . 4 2 Normative references . 4 Foreword. 3 3 Terms and definitions. 5 Fundamental requirements (for non-active and active ophthalmic instruments) 5 4.1 General. 5 4.3 Performance 5 4.2 Design 5 4.4 Combination of different devi

21、ces 5 4.6 Protection against contaminants 6 4.9 Mechanical hazards 6 4.5 Materials 6 4.7 Scales and displays 6 4.8 Thermal hazards . 6 Environmental conditions (for non-active and active ophthalmic instruments) 6 5.1 Environmental conditions of use 6 5.2 Storage conditions . 7 5.3 Transport conditio

22、ns 7 Particular requirements for active ophthalmic instruments 8 6.1 Electrical safety. 8 Optical radiation hazard. 8 7.3 Environmental conditions 8 7 Test methods. 8 7.2 Surface temperatures. 8 6.2 Inapplicable clauses of IEC 60601-1:2005 8 7.1 Ignitability 8 7.4 Checking electrical safety 10 8 Inf

23、ormation supplied by the manufacturer 10 8.2 Marking 10 Annex A (informative) Product-related International Standards for ophthalmic instruments . 11 8.1 Accompanying documents 10 Requirements of EU Directive 93/42/EEC 12 Foreword The text of ISO 15004-1:2006 has been prepared by Technical Committee

24、 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 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

25、 national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting national standards shall 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 p

26、atent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 15004-1:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports es

27、sential 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 Directive 2007/47/EC, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national s

28、tandards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland

29、, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15004-1:2006 has been approved by CEN as a EN ISO 15004-1:2009 without any modification. EN ISO 15004-1:2009 (E) DIN EN ISO 15004-1:2009-07 31 Scope This part of ISO 15004 s

30、pecifies 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 ap

31、plicable 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 undate

32、d references, 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 str

33、ess 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: Gener

34、al 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-wir

35、e based test methods Glow-wire flammability test method for end-products 1) To be published. (Revision of ISO 15004:1997) EN ISO 15004-1:2009 (E) DIN EN ISO 15004-1:2009-07 43 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 ophthalmic instrumen

36、t 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 ophthalmic instrument t

37、hat 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 instrument and th

38、e 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 instruments) 4.1 Gen

39、eral 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 the relevant produc

40、t-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 provid

41、ed 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 achieve the performance stipulated by the manufacturer for the intended function(s) under the intended condit

42、ions of use. 4.4 Combination of different devices If another device is intended for use in combination with an ophthalmic instrument, the connecting system shall not impair the specified performance of either instrument. For coupling with active ophthalmic instruments, the provisions of IEC 60601-1-

43、1 shall apply. EN ISO 15004-1:2009 (E) DIN EN ISO 15004-1:2009-07 54.5 Materials 4.5.1 Components of the ophthalmic instrument which are designed to come into direct contact with the skin of the patient or operator shall be made of materials which are neither toxic nor known to create significant al

44、lergic reactions, when used as intended by the manufacturer. 4.5.2 Materials used shall not ignite. When tested as described in 7.1, combustion shall not continue after withdrawal of the glow-wire. 4.6 Protection against contaminants Parts of the ophthalmic instrument which are designed to come into

45、 contact with the patient or the operator shall either be capable of easy disinfection or be protected by a disposable cover. 4.7 Scales and displays Scales and displays of ophthalmic instruments shall be designed and placed in accordance with ergonomic principles, taking into account the intended p

46、urpose of the instrument. 4.8 Thermal hazards The temperature of parts of the ophthalmic instrument held by the operator or accessible to the patient shall not exceed the allowable maximum temperatures given in Tables 22, 23 and 24 of IEC 60601-1:2005, 11.1. 4.9 Mechanical hazards The ophthalmic ins

47、trument shall be designed so that, when used to perform the intended function(s) in conformance with the users instructions, the risk of physical injury when using this instrument is reduced as much as is practicable. 5 Environmental conditions (for non-active and active ophthalmic instruments) NOTE

48、 The requirements specified in 5.1, 5.2 and 5.3 are verified as described in 7.3. 5.1 Environmental conditions of use The ophthalmic instrument shall conform to all safety, optical, mechanical and accuracy requirements under the environmental conditions given in Table 1. Table 1 Environmental condit

49、ions of use Criterion Environmental conditions Temperature + 10 C to + 35 C Relative humidity 30 % to 90 % Atmospheric pressure 800 hPa to 1 060 hPa Shock (without packing)a10 g, duration 6 ms a Applicable to hand-held instruments only. EN ISO 15004-1:2009 (E) DIN EN ISO 15004-1:2009-07 65.2 Storage conditions 5.2.1 After being stored under the conditions given in Table 2, the ophthalmic instrument shall conform to all safety, optical, mechanical and accuracy requirements under the environmental conditio