IEC SRD 63219:2022
(Main)Active assisted living (AAL) system development guidance for AAL service providers
Active assisted living (AAL) system development guidance for AAL service providers
IEC SRD 63219:2022 provides guidance for AAL service providers to design, procure, implement, and maintain AAL systems throughout their service life.
The objective is to ensure that AAL systems are designed, configured, and installed to meet the needs of the AAL user and the requirements from applicable industry standards and global regulations. Ultimately, however, users of this document are responsible for checking the applicable laws and regulations.
This document is intended for use by persons and organizations acting within an AAL service organization such as employees, contractors, and consultants and those working with external AAL technology vendors, as appropriate.
This document provides guidance on ensuring that AAL systems meet the needs of the AAL service user, in terms of safety, security, privacy, usability, accessibility, performance and interoperability.
This document provides guidance to supplement the AAL service organization's established policies and procedures.
General Information
Standards Content (Sample)
IEC SRD 63219 ®
Edition 1.0 2022-02
SYSTEMS
REFERENCE DELIVERABLE
Active assisted living (AAL) system development guidance for AAL service
providers
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IEC SRD 63219 ®
Edition 1.0 2022-02
SYSTEMS
REFERENCE DELIVERABLE
Active assisted living (AAL) system development guidance for AAL service
providers
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 03.080; 11.180 ISBN 978-2-8322-1083-5
– 2 – IEC SRD 63219:2022 © IEC 2022
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 7
4 AAL service organization responsibilities . 8
5 AAL system development process . 9
5.1 General . 9
5.2 Use cases . 9
5.3 AAL reference architecture and architecture model . 10
5.4 Applicable standards . 10
5.5 Global/local regulatory requirements . 11
6 AAL system validation . 11
7 AAL system verification . 11
7.1 Industry standards . 11
7.2 Regulations . 11
8 AAL system evaluation . 12
8.1 Identifying gaps in the design of AAL technical component actors . 12
8.2 Closing gaps . 12
9 AAL service organization recommendations . 12
9.1 Policies and procedures . 12
9.1.1 General . 12
9.1.2 Internal to the AAL service organization . 13
9.1.3 External to the AAL service organization . 13
9.2 AAL service organization approvals . 13
Annex A (informative) International Standards on usability, human factors, and risk
management . 14
Annex B (informative) Standards/regulatory tracking . 15
Annex C (informative) AAL system development . 16
C.1 General . 16
C.2 Determine the user and use environments . 17
C.2.1 User considerations when developing AAL systems . 17
C.2.2 Environmental considerations when developing AAL systems . 17
C.3 Determine AAL system components . 17
C.4 Develop usability/human factor evaluation . 17
C.5 AAL system validation . 17
C.6 AAL system verification . 18
C.7 Identify gaps in AAL system design . 18
C.8 Objective evidence (Certification). 18
Bibliography . 19
Figure 1 – AAL system design progression (inputs to output) . 9
Figure 2 – Example: Use case 1 from IEC TS 63134 . 10
Figure 3 – AAL system validation/verification . 11
Figure C.1 − AAL system development . 16
Table A.1 – Examples of International Standards on usability, human factors, and risk
management . 14
Table B.1 – Example of standards/regulatory tracking (device) . 15
Table B.2 – Example of standards/regulatory tracking (system) . 15
– 4 – IEC SRD 63219:2022 © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ACTIVE ASSISTED LIVING (AAL) SYSTEM DEVELOPMENT
GUIDANCE FOR AAL SERVICE PROVIDERS
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
IEC SRD 63219, which is a Systems Reference Deliverable, has been prepared by IEC systems
committee Active Assisted Living.
The text of this Systems Reference Deliverable is based on the following documents:
Draft SRD Report on voting
SyCAAL/247/DTS SyCAAL/257/RVDTS
Full information on the voting for its approval can be found in the report on voting indicated in
the above table.
The language used for the development of this Systems Reference Deliverable is English.
This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in
accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available
at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are
described in greater detail at www.iec.ch/standardsdev/publications.
The committee has decided that the contents of this document will remain unchanged until the
stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – IEC SRD 63219:2022 © IEC 2022
INTRODUCTION
AAL systems can comprise a compilation of components, systems, and services from multiple
vendors and service providers. It is important that the parts of an AAL system are compatible
in terms of safety, usability, accessibility, performance, and interoperability. It is also important
that the security and privacy of the AAL user is protected.
This document provides guidelines for the design of AAL systems to ensure that the AAL
systems are designed and developed to be compatible with and to meet the needs of the AAL
user.
This document is intended for AAL service providers and AAL service organizations responsible
for using, installing, and supporting AAL systems.
ACTIVE ASSISTED LIVING (AAL) SYSTEM DEVELOPMENT
GUIDANCE FOR AAL SERVICE PROVIDERS
1 Scope
This document provides guidance for AAL service providers to design, procure, implement, and
maintain AAL systems throughout their service life.
The objective
...
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