IEC SRD 63219:2022

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
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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
...