1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-23299-3 SANS 16201:2009Edition 1ISO 16201:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Technical aids for persons with disability Environm
4、ental control systems for daily living This national standard is the identical implementation of ISO 16201:2006 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Te
5、l: +27 12 428 7911 Fax: +27 12 344 1568 www.sabs.co.za SABS SANS 16201:2009 Edition 1 ISO 16201:2006 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 185, Consumer Policy Committee (COPOLCO), in accordance with
6、procedures of the SABS Standards Division, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in September 2009. Reference numberISO 16201:2006(E)ISO 2006INTERNATIONAL STANDARD ISO16201First edition2006-10-01Technical aids for persons with disability Environmental
7、control systems for daily living Aides techniques pour personnes handicapes Systmes de commande distance pour la vie quotidienne SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 16201:2006(E) PDF disclaimer This PDF file may
8、 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 computer performing the editing. In downloading this file, parties accept therein the respo
9、nsibility of not infringing Adobes 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-creatio
10、n 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 2006 All rights reserved. Unless o
11、therwise 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 ISOs member body in the country of the requester. ISO copyr
12、ight 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 in Switzerland ii ISO 2006 All rights reservedSANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of th
13、e SABS .ISO 16201:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 2 4 General requirements. 3 4.1 Risk management . 3 4.2 Information supplied by the manufacturer 3 4.3 Materials 4 5 Functional requireme
14、nts and test methods. 4 5.1 General. 4 5.2 Design 5 5.3 User interface 5 5.4 Controlled functions. 7 6 Technical safety requirements and test methods . 9 Annex A (informative) Guidance notes 11 SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing client
15、s of the SABS .ISO 16201:2006(E) iv ISO 2006 All rights reservedForeword 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 co
16、mmittees. 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 th
17、e 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 2. The main task of technical committees is to prepare International Standards. Draft Internati
18、onal 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 document may be
19、the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 16201 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 293, Assistive products for persons with disability, in collaboration with Technical Co
20、mmittee ISO/TC 173, Assistive products for persons with disability, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 16201:200
21、6(E) ISO 2006 All rights reserved vIntroduction This International Standard provides one means to demonstrate that environmental control systems for persons with disability, which are also medical devices, conform to the essential requirements outlined in general terms in Annex 1 of the EU Directive
22、 93/42 EEC. It is not intended to provide a means to show conformity with the requirements of any other directive. There are three levels of European Standards dealing with technical aids for persons with disability. These are as follows, with level 1 being the highest: a) Level 1: general requireme
23、nts for technical aids; b) Level 2: particular requirements for families of technical aids; c) Level 3: specific requirements for types of technical aids. Where standards for particular aids or groups of aids exist (Level 2 or 3), the requirements of lower level standards take precedence over higher
24、 level standards. Therefore, to address all requirements for a particular aid, it is necessary to start with standards of the lowest available standard. This is a combined Level 2, and Level 3 standard (lowest possible) for environmental control systems for persons with disability, which are also me
25、dical devices, as specified in the scope. SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .INTERNATIONAL ST
26、ANDARD ISO 16201:2006(E) ISO 2006 All rights reserved 1Technical aids for persons with disability Environmental control systems for daily living 1 Scope This International Standard specifies functional and technical requirements and test methods for environmental control systems intended for use to
27、alleviate or compensate for a disability. NOTE Such systems are also known as electronic aids to daily living. The aim of this International Standard is to provide safety requirements and recommendations for manufacturers of such environmental control systems. Target devices are not covered by this
28、International Standard. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated refer
29、ences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14971, Medical devices Application of risk management to medical devices EN 55011, Industrial, scientific and medical (ISM) radio-frequency equipment R
30、adio disturbance characteristics Limits and methods of measurement IEC 60529, Degrees of protection provided by enclosures (IP Code) IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-1, Medical electrical equipment Part 1-1:
31、 General requirements for safety Collateral standard: Safety requirements for medical electrical systems IEC 60825-1, Safety of laser products Part 1: Equipment classification, requirements and users guide IEC 60950-1, Information technology equipment Safety Part 1: General requirements SANS 16201:2
32、009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 16201:2006(E) 2 ISO 2006 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions apply. For the safety and test methods of electr
33、ical equipment, the terms and definitions given in IEC 60601-1 apply. 3.1 applied part part of the environmental control system that in normal use necessarily comes into physical contact with the person with disability for the environmental control system to perform its function EXAMPLE Microphones
34、that are mounted close to a person with disability. 3.2 central unit unit receiving and handling the information from input and/or target devices and giving output for the execution of appropriate functions 3.3 environmental control system system, which provides a means for people with disabilities
35、to remotely control and operate electronic and electrical equipment that are part of the system within the living environment and is intended to enable users to function as independently as possible regardless of disability and environment NOTE An environmental control system might be part of some o
36、ther systems or equipment, e.g. communication aid or electric wheelchair. 3.4 feedback information, which is returned to the user from the environmental control system NOTE This information assists the user in selecting the desired function or confirms the outcome of the selection. 3.5 hand-held dev
37、ice piece of equipment intended to be supported by the hand during normal use 3.6 input device device by which a command signal is given to a central unit, or directly to a target device 3.7 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling
38、 of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party 3.8 target device device or equipment, which is controlled or operated by an input device and/or a central unit EXAMPLE D
39、oor opener. 3.9 user person using the environmental control system, either a person with disability and/or an assistant 3.10 user connection every individual part of the applied part through which current can flow between a user and the environmental control system in normal condition or single faul
40、t condition SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 16201:2006(E) ISO 2006 All rights reserved 34 General requirements 4.1 Risk management The safety of the system shall be assessed by identifying hazards and estima
41、ting the risks associated with them using the procedure specified in ISO 14971. 4.2 Information supplied by the manufacturer 4.2.1 General At least the following information shall be available in an unambiguous and understandable way and in the official language(s) of countries in which the environm
42、ental control system or devices comprising such a system are marketed: a) advice on which other devices and/or types of device can be used in combination; b) information needed to install and maintain the equipment, e.g. installation and service manuals; c) information on how to handle and use it sa
43、fely, presented in an unambiguous and understandable way to user; d) manufacturer and supplier identification; e) identification of the system, e.g. model and serial number; f) level of protection of electrical equipment against the ingress of liquids and advice on the intended environments of use a
44、nd related safety recommendations; g) any cleaning instructions; h) details of the nature, type, intensity and distribution of any radiation transmitted; i) potential adverse interaction with other equipment; j) detailed information on the replaceability of components. The input device shall be clea
45、rly described by the manufacturer in terms of type and number of communication ports, type and number of communication methods, power supply, etc. as applicable. The individual key or button on the input device shall be clearly described in terms of size, mass, force and distance required to activat
46、e. If different types of selection feedback from the user interface are present, all types shall be clearly described. 4.2.2 Instructions for use The instructions shall contain at least the following information: a) information necessary to operate the environmental control system and/or any individ
47、ual device in the system; b) description of the functions and performances of the environmental control system and/or any individual device in the system including the extension options; c) if connection to other devices or equipment is needed, sufficient details of characteristics to identify the c
48、orrect devices or equipment for a safe combination; SANS 16201:2009This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 16201:2006(E) 4 ISO 2006 All rights reservedd) details of the nature and frequency of the maintenance and calibration neede
49、d; e) description of used symbols and colours. The instructions should be available in alternative format, e.g. audio or electronic for the use of persons with visual impairment. 4.2.3 Labelling On the product/packaging/instructions as appropriate, based on the safe use of the environmental control system and/or any individual device in the system the labelling shall contain at least the following information: a) name or trade name and address of the manufacturer or supplier; b) details necessary for the identification o
