ISO-10936-2-2001.pdf
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1、Reference number ISO 10936-2:2001(E) ISO 2001 INTERNATIONAL STANDARD ISO 10936-2 First edition 2001-01-15 Optics and optical instruments Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery Optique et instruments doptique Microscopes chirurgicaux Partie 2: Dan
2、ger de la lumire provenant des microscopes opratoires utiliss en chirurgie oculaire Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 01:43:39 MDTNo reproduction or networking perm
3、itted without license from IHS -,-,- ISO 10936-2:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the co
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6、he Central Secretariat at the address given below. ISO 2001 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from eithe
7、r ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 ? CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii ISO 2001 All rights reserved Copyright International O
8、rganization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 01:43:39 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-2:2001(E) ISO 2001 All rights reservediii ContentsPage Forewor
9、d.iv 1Scope 1 2Normative references1 3Terms and definitions .1 4Requirements for optical radiation hazard .3 4.1General3 4.2Limit values3 4.3Visible light.4 4.4Retinal safety filter.5 5Test methods5 5.1General5 5.2Checking optical radiation safety 5 5.3Determination of beam cross-section .5 6Informa
10、tion supplied by the manufacturer .5 7Marking.6 Annex A (normative) Optical radiation hazard.7 Annex B (normative) Information supplied by the manufacturer 9 Annex C (informative) Photometric measures .10 Copyright International Organization for Standardization Provided by IHS under license with ISO
11、 Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 01:43:39 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-2:2001(E) iv ISO 2001 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federatio
12、n 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 that committee.
13、 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 in accordance wi
14、th the rules given in the ISO/IEC Directives, Part 3. 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 casting a vote. Attention is drawn
15、to the possibility that some of the elements of this part of ISO 10936 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 10936-2 was prepared by Technical Committee ISO/TC 172, Optics and optical instrumen
16、ts, Subcommittee SC 7, Ophthalmic optics and instruments. ISO 10936 consists of the following parts, under the general title Optics and optical instruments Operation microscopes: ?Part 1: Requirements and test methods ?Part 2: Light hazard from operation microscopes used in ocular surgery Annexes A
17、and B form a normative part of this part of ISO 10936. Annex C is for information only. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/21/2007 01:43:39 MDTNo reproduction or networking
18、permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 10936-2:2001(E) ISO 2001 All rights reserved1 Optics and optical instruments Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery 1Scope This part of ISO 10936 specifies requirements and test m
19、ethods for optical radiation hazards from operation microscopes which are used during ocular surgery. NOTEGeneral requirements for operation microscopes and test methods for these requirements are specified in ISO 10936-1. 2Normative references The following normative documents contain provisions wh
20、ich, through reference in this text, constitute provisions of this part of ISO 10936. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 10936 are encouraged to investigate the possibility
21、of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 10936-1:2000, Optics and optical instru
22、ments Operation microscopes Part 1: Requirements and test methods. IEC 60601-1:1988,MedicalelectricalequipmentPart 1:Generalrequirementsforsafety,including Amendment 1:1991, including Amendment 2:1995. 3Terms and definitions For the purposes of this part of ISO 10936, the following terms and definit
23、ions apply. 3.1 auxiliary beam off-axis beam attached to or an integral part of the microscope and intended to illuminate the eye 3.2 corneal plane plane that is perpendicular to the optical axis of the instrument and that is tangential to the corneal surface closest to the instrument when in normal
24、 use 3.3 photoretinitis retinal photochemically induced injury resulting from intense retinal radiant exposure NOTEPhotic maculopathy is a term also used to describe photoretinitis in the fovea-macular area of the retina. Copyright International Organization for Standardization Provided by IHS under
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