EN ISO 16201:2006

SLOVENSKI STANDARD
01-december-2006
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Technical aids for disabled persons - Environmental control systems for daily living (ISO
16201:2006)
Technische Hilfen für Menschen mit Behinderungen - Umgebungs-Steuersysteme für
das Alltagsleben (ISO 16201:2006)
Aides techniques pour personnes avec un handicap - Systemes de commande a
distance pour la vie quotidienne (ISO 16201:2006)
Ta slovenski standard je istoveten z: EN ISO 16201:2006
ICS:
11.180.01 3ULSRPRþNL]D Aids for disabled and
RQHVSRVREOMHQHLQ handicapped persons in
KHQGLNHSLUDQHRVHEHQD general
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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 16201
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2006
ICS 11.180.01
English Version
Technical aids for disabled persons - Environmental control
systems for daily living (ISO 16201:2006)
Aides techniques pour personnes avec un handicap - Technische Hilfen für Behinderte - Umgebungs-
Systèmes de commande à distance pour la vie quotidienne Steuersysteme für das Alltagsleben (ISO 16201:2006)
(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 European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards 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 version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of 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 Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16201:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 16201:2006) has been prepared by Technical Committee CEN/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 by 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 supports 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 this 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 Kingdom.

Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC

This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide one means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC, Medical Devices Directive.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) of Essential requirements (ERs) Qualifying remarks/Notes
this European Standard
of EU Directive 93/42/EEC
All 1, 2, 3, 4, 5.
4.1 6
4.2 9.1, 11.4, 13
4.3 7.1 Only flammability and
biocompatibility considered.
5.1 12.1
5.2 12.9
6 9.1, 9.2, 9.3, 11.3, 12.5, 12.6,
12.7.1, 12.7.4, 12.7.5
WARNING: Other requirements and other EU Directives may be applicable to the products falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 16201
First edition
2006-10-01
Technical aids for persons with
disability — Environmental control
systems for daily living
Aides techniques pour personnes handicapées — Systèmes de
commande à distance pour la vie quotidienne

Reference number
ISO 16201:2006(E)
©
ISO 2006
ISO 16201:2006(E)
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ii © ISO 2006 – All rights reserved

ISO 16201:2006(E)
Contents 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 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

ISO 16201:2006(E)
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 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 bodies 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) Technical 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).
iv © ISO 2006 – All rights reserved

ISO 16201:2006(E)
Introduction
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 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: 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 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 medical devices, as specified in the scope.
INTERNATIONAL STANDARD ISO 16201:2006(E)

Technical 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 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 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
references, 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 — Radio 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: 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 user's guide
IEC 60950-1, Information technology equipment — Safety — Part 1: General requirements
ISO 16201:2006(E)
3 Terms and definitions
For 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 contact 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
of 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 independently 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 information 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 device
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
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 through which current can flow between a user and the environmental
control system in normal condition or single fault condition
2 © ISO 2006 – All rights reserved

ISO 16201:2006(E)
4 General requirements
4.1 Risk management
The safety of the system shall be assessed by identifying hazards and estimating 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 environmental 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 safely, 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 and 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 clearly 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 activate.
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 individual 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
correct devices or equipment for a safe combination;
ISO 16201:2006(E)
d) details of the nature and frequency of the maintenance and calibration needed;
e)
...