ISO-10936-1-2000.pdf

Reference number ISO 10936-1:2000(E) ©ISO 2000 INTERNATIONAL STANDARD ISO 10936-1 First edition 2000-06-15 Optics and optical instruments Operation microscopes Part 1: Requirements and test methods Optique et instruments d'optique Microscopes chirurgicaux Partie 1: Exigences et méthodes d'essai Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's 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 computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ©ISO 2000 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 either ISO at the address below or ISO's 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 22 734 10 79 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland ii© ISO 2000 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) © ISO 2000 All rights reservediii 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 member 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with 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 to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 10936-1 was prepared by Technical Committee ISO/TC 172,Optics and optical instruments, Subcommittee SC 5,Microscopes and endoscopes. ISO 10936 consists of the following parts, under the general titleOptics and optical instruments Operation microscopes: ?Part 1: Requirements and test methods ?Part 2: Light hazard from operation microscopes used in ocular surgery Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARDISO 10936-1:2000(E) © ISO 2000 All rights reserved1 Optics and optical instruments Operation microscopes Part 1: Requirements and test methods 1Scope This part of ISO 10936 specifies requirements and refers to test methods for operation microscopes used for observation during surgical operation and treatment of patients. It does not apply to accessories, e.g. photographic cameras. NOTESpecific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 10936-2. 2Normative references The following normative documents contain provisions which, 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 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 7944:1998,Optics and optical instruments Reference wavelengths. ISO 8039:1997,Optics and optical instruments Microscopes Magnification. ISO 9022 (all parts),Optics and optical instruments Environmental test methods. ISO 10934 (all parts)1?,Optics and optical instruments Vocabulary for microscopy. ISO 11883:1997,Optics and optical instruments Microscopes Marking of stereomicroscopes. ISO 15227:2000,Optics and optical instruments Microscopes Testing of stereomicroscopes. IEC 60601-1:1988,Medical electrical equipment Part 1: General requirements for safety(including Amend- ment 1:1991 and Amendment 2:1995. IEC 60601-2-22:1995,Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment. 1?To be published. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) 2© ISO 2000 All rights reserved 3Terms and definitions For the purposes of this part of ISO 10936, the terms and definitions given in ISO 8039 and ISO 10934 and the following apply. 3.1 operation microscope stereomicroscope used for observation of surgical and other medical procedures, consisting of an optical system of observation, including objective lens, variable or fixed power optical system, observation tube and eyepieces EXAMPLEColposcopes 4Requirements 4.1General The operation microscope shall comply with the requirements given in 4.2 to 4.4. All requirements given below are minimum requirements. They apply to the reference wavelength according to ISO 7944. 4.2Optical and mechanical requirements The requirements given in Table 1 apply. Testing of optical and mechanical requirements shall be carried out in accordance with 5.2. 4.3Environmental conditions The operation microscope shall comply with the environmental requirements given in IEC 60601-1. NOTEThe test requirements given in ISO 10109-6 do not apply. 4.4Safety The requirements of IEC 60601-1 shall apply, with the following modification: 42.1 of IEC 60601-1 shall not apply. 5Test methods 5.1General All tests specified in this part of ISO 10936 are type tests. 5.2Checking the optical and mechanical specifications The requirements according to 4.2 shall be checked with measuring devices the measuring error of which shall be smaller than 10 % of the value to be determined in accordance with ISO 15227. Measurements shall be carried out in accordance with general rules of statistical evaluation. 5.3Checking the environmental conditions Testing of environmental conditions shall be carried out in accordance with ISO 9022. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) © ISO 2000 All rights reserved3 5.4Checking the safety Testing of safety shall be carried out in accordance with IEC 60601-1. 6Marking The operation microscope shall be permanently marked with at least the markings according to IEC 60601-1. Table 1 Requirements for optical and mechanical specifications CriterionRequirement Tolerance of total magnification? 7,5 % Difference in magnification between left and right optical systemsu 1,5 % verticalu 15? convergenceu 45? Difference in axis between left and right optical systems b horizontal a divergenceu 10? Shift of focusing planes by magnification changeaxial object plane S0u 3 · DF c, d Focus difference between left and right optical systems DL/Ru 1,5 · DF c At highest magnification the resolving power in the centre of the field should be a minimum of 1800 · NA line pairs/mm Difference in imaging rotation between right and left imagesu 2° difference in exit pupil height between left and right optical systems u 1,5 mm at 0 D on the dioptre scale calibration error of a dioptre scale, if used? 0,25 D at 0 D on the dioptre scale minimum range for interpupillary distance55 mm to 75 mm general+5 D to 5 D Eyepiece minimum adjustment range high eye point+ 2 D to 4 D a This requirement does not apply to those operation microscopes where the mechanical axes of the eyepieces are not parallel to each other due to the design. b Including a 10? eyepiece at 0 D adjustment. c The admissible axial shift of the focusing plane is determined by: 1 27 F 2 TOT VIS D NAMNA ? ? ? where DFis the depth of field of lens, in millimetres; MTOT VISis the total visual magnification (highest value); ?is the wavelength, in millimetres; NAis the numerical aperture. The second part of this equation is based on the resolution of the eye of 2?. d S0is the shift of object plane. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) 4© ISO 2000 All rights reserved Bibliography 1ISO 10109-6:1994,Optics and optical instruments Environmental requirements Part 6: Test requirements for medical optical devices 2ISO 10936-2:2),Optics and optical instruments Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery. 2)To be published. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 10936-1:2000(E) ICS 11.040.99 Price based on 4 pages © ISO 2000 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/24/2007 21:19:43 MDTNo reproduction or networking permitted without license from IHS -,-,-