ISO-11197-2004.pdf
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1、 Reference number ISO 11197:2004(E) ISO 2004 INTERNATIONAL STANDARD ISO 11197 Second edition 2004-12-15 Medical supply units Gaines techniques usage mdical Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 N
2、ot for Resale, 04/07/2007 22:29:23 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11197:2004(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 th
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5、unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2004 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, includin
6、g photocopying and microfilm, without permission in writing from either 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.org Web www.iso.org Published
7、in Switzerland ii ISO 2004 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 22:29:23 MDTNo reproduction or networking permitted without license from IHS -,-,-
8、ISO 11197:2004(E) ISO 2004 All rights reserved iii 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. Eac
9、h 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 Internation
10、al 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 2. The main task of technical committees is to prepare International Standards. Draft International Standard
11、s 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 document may be the subject o
12、f patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 11197 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas sys
13、tems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard.” to mean “.this International Standard.”. This second edition cancels and replaces the first edition (ISO 11197:1996), which ha
14、s been technically revised. Annex ZB provides a list of corresponding International and European Standards for which equivalents are not given in the text. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. Copyright I
15、nternational Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/07/2007 22:29:23 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11197:2004(E) iv ISO 2004 All rights reserved Contents
16、 page Forewordvii Introductionviii SECTION ONE - GENERAL 1 1 Scope 1 2 Normative references 1 3 Terms and definitions .2 4 General requirements and requirements for tests.2 5 Classification3 6 Identification, marking and documents.3 7 Power input 7 SECTION TWO - ENVIRONMENTAL CONDITIONS8 8 Basic saf
17、ety categories.8 9 Removable protection means.8 10 Environmental conditions.8 11 Not Used .8 12 Not Used .8 SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.9 13 General9 14 Requirements related to classification9 15 Limitation of voltage and/or energy.9 16 Enclosures and protective covers
18、.9 17 Separation 9 18 Protective earthing, functional earthing and potential equalization 9 19 Continuous leakage current and patient auxiliary currents9 20 Dielectric strength .10 SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS 11 21 Mechanical strength 11 22 Moving parts.11 23 Surfaces, corne
19、rs and edges11 24 Stability in normal use 11 25 Expelled parts 12 26 Vibration and noise12 27 Pneumatic and hydraulic power.12 28 Suspended masses .12 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not fo
20、r Resale, 04/07/2007 22:29:23 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 11197:2004(E) ISO 2004 All rights reserved v SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.13 29 X-Radiation.13 30 Alpha, beta, gamma, neutron radiation and ot
21、her particle radiation .13 31 Microwave radiation 13 32 Light radiation (including lasers).13 33 Infra-red radiation13 34 Ultraviolet radiation.13 35 Acoustical energy (including ultrasonics)13 36 Electromagnetic compatibility .13 SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANA
22、ESTHETIC MIXTURES 15 37 Locations and basic requirements 15 38 Marking and accompanying documents.15 39 Common requirements for Category AP and Category APG Equipment15 40 Requirements and tests for Category AP Equipment, parts and components thereof .15 41 Requirements and tests for Category APG Eq
23、uipment, parts and components thereof.15 SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS .16 42 Excessive temperatures16 43 R Fire prevention .16 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection.16 45 Pressure v
24、essels and parts subject to pressure16 46 Human errors .17 47 Electrostatic charges 17 48 Material in applied parts in contact with the body of the patient .17 49 Interruption of the power supply .17 SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT18 50 Accuracy of
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