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1、BRITISH STANDARD BS EN ISO 15004:1998 Ophthalmic instruments Fundamental requirements and test methods The European Standard EN ISO 15004:1997 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
2、 BS EN ISO 15004:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority the Standard Board and comes into effect on 15 April 1998 BSI 07-1999 ISBN 0 580 29352 1 National foreword This British Standard is the
3、English language version of EN ISO 15004:1997. It is identical with ISO 15004:1997. The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/6, Ophthalmic instruments, which has the responsibility to: aid enquirers to understand the
4、 text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subc
5、ommittee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists nonnative references to international publications with their corresponding European publications. The British Standards which im
6、plement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not pu
7、rport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front
8、 cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 12 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments
9、 issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 15004:1998 BSI 07-1999i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of ISO 150041 Licensed Copy: sheffi
10、eldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15004 December 1997 ICS 11.040.70 Descrip
11、tors: See ISO document English version Ophthalmic instruments Fundamental requirements and test methods (ISO 15004:1997) Instruments ophtalmiques Exigences fondamentales et mthodes dessai (ISO 15004:1997) Ophthalmische Instrumente Grundlegende Anforderungen und Prfverfahren (ISO 15004:1997) This Eur
12、opean Standard was approved by CEN on 4 December 1997. CEN members are bound to comply with the CEN/CENELEC 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
13、concerning such national standards may be obtained on application to the Central Secretariat 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
14、 own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain,
15、 Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN natio
16、nal Members. Ref. No. EN ISO 15004:1997 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 15004:1997 BSI 07-1999 2 Foreword The text of the International Standard ISO 15004:1997 has been prepared by Technical Committee ISO/TC 194 “Bio
17、logical evaluation of medical devices” in collaboration 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 late
18、st by June 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard 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 rel
19、ationship with EU Directives, see informative Annex ZA, which is an integral part of this standard. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denm
20、ark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 15004:1997 was approved by CEN as a European Standard without any modification.
21、Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 15004:1997 ii BSI 07-1999 Contents Page Forewordiii 1Scope1 2Normative referenc
22、es1 3Definitions1 4Fundamental requirements (for non-active and active ophthalmic instruments)2 5Environmental conditions (for non-active and active ophthalmic instruments)3 6Particular requirements for active ophthalmic instruments4 7Test methods5 8Information supplied by the manufacturer7 Annex A
23、(normative) Optical radiation hazard8 Annex B (normative) Product-related International Standards for ophthalmic instruments9 Annex C (informative) Photometric quantities10 Annex D (informative) Example of information on the avoidance of overexposure to potentially hazardous optical radiation11 Anne
24、x ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives12 Figure C.1 Solid angle subtended by a light source10 Table 1 Environmental condition3 Table 2 Storage conditions3 Table 3 Transport conditions4 Table 4 Environmental tests6 T
25、able ZB.1 Correspondence between this European Standard and EU Directives12 Descriptors: Optics, optical equipment, ophthalmic equipment, classification, specifications, tests, type testing (tests), marking. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled
26、 Copy, (c) BSI EN ISO 15004:1997 BSI 07-1999iii Foreword ISO (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 committees. Each m
27、ember 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 the International
28、Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International 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 cas
29、ting a vote. International Standard ISO 15004 was prepared by ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annex A and Annex B form an integral part of this International Standard. Annex C and Annex D are for information only. Licensed Copy: sheff
30、ieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 15004:1997 BSI 07-19991 1 Scope This International Standard specifies Fundamental requirem
31、ents for non-invasive, active and non-active ophthalmic instruments. This International Standard 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 International Standard takes precedence over the co
32、rresponding requirements of the other general standards cited in clause 2, if differences exist. This International Standard does not apply to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye. 2 Normative references The following standards
33、contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to inves
34、tigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9022-2:1994, Optics and optical instruments Environmental test methods Part 2: Cold, heat, humidity. ISO 9022-3:1994
35、, Optics and optical instruments Environmental test methods Part 3: Mechanical stress. IEC 60601-1:1988, Medical electrical equipment Part 1: General requirements for safety. IEC 60601-1-1:1992, Medical electrical equipment Part 1: General requirements for safety. 1. Collateral standard: Safety requ
36、irements for medical electrical systems. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 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
37、 the surface of the body 3.2 active ophthalmic instrument any ophthalmic instrument connected with a permanently installed source of electrical power energy 3.3 manufacturer (of an ophthalmic instrument) natural or legal person who places the ophthalmic instrument on the market 3.4 optical radiation
38、 hazard possibility of damage to the retina by optical radiation NOTEThe effect of the radiance of a source (see 3.6) will decrease as the light beam passes through an optical system due to filtering, absorption or other loss mechanisms. Thus, basing the optical radiation hazard on the source radian
39、ce ensures that the radiance at the retina cannot exceed the source radiance. 3.5 irradiance, E radiant flux d incident on an element of a surface of unit area dA NOTEIrradiance is expressed in milliwatts per square centimetre (mW/cm2). 3.6 radiance, L in a given direction at a given point, the quot
40、ient of the radiant flux d9 passing through that point and propagating within the solid angle d in a direction divided by the product of the area of a section of that beam on a plane perpendicular to this direction containing the given point and the solid angle d (see C.1) NOTERadiance is expressed
41、in milliwatts per square centimetre per steradian mW/(cm2 sr). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 15004:1997 2 BSI 07-1999 3.7 spectral radiance, L2() value of the radiance (see 3.6) of an infinitesimal wavelength interva
42、l, at any given wavelength in the spectrum, divided by the range of that interval NOTESpectral radiance is expressed in milliwatts per square centimetre per steradian per nanometer mW/(cm2 srnm). 3.8 spectrally weighted photochemical aphakic source radiance, LA spectral radiance of the source integr
43、ated over the aphakic spectrum range 305 nm to 700 nm and weighted by A(2) as given by the equation: where A() is the spectral weighting function for the aphakic retinal hazard analysis (see Annex A) 3.9 spectrally weighted photochemical phakic source radiance, LB spectral radiance of the source int
44、egrated over the phakic spectrum range 380 nm to 700 nm and weighted by B() as given by the equation: where B() is the spectral weighting function for the phakic retinal hazard analysis (see Annex A) 4 Fundamental requirements (for non-active and active ophthalmic instruments) 4.1 Design Ophthalmic
45、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. 4.2 Performance The op
46、hthalmic instrument shall achieve the performance stipulated by the manufacturer for the intended function(s) under the intended conditions of use. In addition to the requirements of this International Standard, the supplementary or modified requirements specified in the relevant product-related Int
47、ernational Standards listed in Annex B apply. 4.3 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 instrument
48、s, the provisions of IEC 60601-1-1 shall apply. 4.4 Materials 4.4.1 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 allergic reactions, w
49、hen used as intended by the manufacturer. 4.4.2 Materials used shall not ignite. When tested as described in 7.1, combustion shall not continue after withdrawal of the test rod. 4.5 Protection against contaminants Parts of the ophthalmic instrument which are designed to come into contact with the patient or the operator shall either be capable of easy disinfection or be protected by a disposable cover. . (1) . (2) Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:54:55 GMT+00:00 2006, Uncontrolled Copy,
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