1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58systems for daily livingThe European Standard EN ISO 16201:2006 has the status of a British Standar
2、dICS 11.180.01Technical aids for disabled persons Environmental control BRITISH STANDARDBS EN ISO 16201:2006BS EN ISO 16201:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2006 BSI 2006ISBN 0 580 49412 8Amendments issued since
3、publicationAmd. No. Date Commentscontract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.National forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 16201:2006. The UK particip
4、ation in its preparation was entrusted to Technical Committee CH/173, Assistive products for persons with disability.A list of organizations represented on CH/173 can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a EUROPEAN STAND
5、ARDNORME EUROPENNEEUROPISCHE NORMEN ISO 16201October 2006ICS 11.180.01English VersionTechnical aids for disabled persons - Environmental controlsystems for daily living (ISO 16201:2006)Aides techniques pour personnes avec un handicap -Systmes de commande distance pour la vie quotidienne(ISO 16201:20
6、06)Technische Hilfen fr Behinderte - Umgebungs-Steuersysteme fr das Alltagsleben (ISO 16201:2006)This European Standard was approved by CEN on 19 August 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the
7、status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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
8、 version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Est
9、onia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISC
10、HES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 16201:2006: EForeword This document (EN ISO 16201:2006) has been prepared by Technical Committee CE
11、N/TC 293 “Assistive products for persons with disability“, the secretariat of which is held by SIS, in collaboration with Technical Committee ISO/TC 173 “Technical systems and aids for disabled or handicapped persons“. This European Standard shall be given the status of a national standard, either b
12、y publication of an identical text or by endorsement, at the latest by April 2007, and conflicting national standards shall be withdrawn at the latest by April 2007. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and s
13、upports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement th
14、is European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdo
15、m. EN ISO 16201:2006Reference numberISO 16201:2006(E)INTERNATIONAL STANDARD ISO16201First edition2006-10-01Technical aids for persons with disability Environmental control systems for daily living Aides techniques pour personnes handicapes Systmes de commande distance pour la vie quotidienne EN ISO
16、16201:2006ii 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 requirements and test methods. 4 5.1 General. 4 5.2
17、 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 EN ISO 16201:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO me
18、mber 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, governme
19、ntal 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 Dire
20、ctives, Part 2. The main task of technical committees is to prepare International Standards. 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 bod
21、ies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be 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) Techni
22、cal Committee CEN/TC 293, Assistive products for persons with disability, in collaboration with Technical Committee ISO/TC 173, Assistive products for persons with disability, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). EN ISO 16201:2006vIntroduc
23、tion 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 93/42 EEC. It is not intended to provide a
24、 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 requirements for technical aids; b) Level 2: particu
25、lar 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 level standards. Therefore, to address all
26、 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 medical devices, as specified in the scope. E
27、N ISO 16201:2006blank1Technical 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 alleviate or compensate for a dis
28、ability. 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 International Standard. Technical
29、 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 references, only the edition cited app
30、lies. 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 Radio disturbance characteristics
31、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: General requirements for safety
32、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 EN ISO 16201:20062 3 Terms and definitions Fo
33、r the purposes of this document, the following terms and definitions apply. For the safety and test methods of electrical 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 cont
34、act with the person with disability for the environmental control system to perform its function EXAMPLE Microphones 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 o
35、f appropriate functions 3.3 environmental control system system, which provides a means for people with disabilities 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 independen
36、tly as possible regardless of disability and environment NOTE An environmental control system might be part of some other 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 infor
37、mation assists the user in selecting the desired function or confirms the outcome of the selection. 3.5 hand-held device 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 dev
38、ice 3.7 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling 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
39、target device device or equipment, which is controlled or operated by an input device and/or a central unit EXAMPLE Door 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
40、through which current can flow between a user and the environmental control system in normal condition or single fault condition EN ISO 16201:200634 General requirements 4.1 Risk management The safety of the system shall be assessed by identifying hazards and estimating the risks associated with the
41、m 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 environmental control system or devices co
42、mprising 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 safely, presented in an unambiguous
43、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 and related safety recommendations;
44、 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 clearly described by the manufacturer
45、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 activate. If different types of selection
46、 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 individual device in the system; b) descr
47、iption 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 correct devices or equipment for a
48、safe combination; EN ISO 16201:20064 d) details of the nature and frequency of the maintenance and calibration needed; 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
49、 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 of the device and the contents on the packaging; c) any special storage and/or handling conditions; d) any special operating instructions; e) any safety warnings and/or precau
