IEC SRD 63219:2022

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

• Status: Published
• Publication Date: 23-Feb-2022
• ICS: 03.080 - Services
• ICS: 11.180 - Aids for disabled or handicapped persons
• Technical Committee: SyC AAL - Active Assisted Living
• Drafting Committee: WG 3 - SyC AAL/WG 3
• Current Stage: PPUB - Publication issued
• Start Date: 24-Feb-2022
• Completion Date: 18-Mar-2022

Overview

IEC SRD 63219:2022 - Active assisted living (AAL) system development guidance for AAL service providers - is a systems reference deliverable published by the IEC that guides AAL service organizations on designing, procuring, implementing, validating, verifying and maintaining AAL systems throughout their service life. The document focuses on ensuring AAL systems meet user needs while conforming to applicable industry standards and global regulations. It is intended for AAL service providers, employees, contractors, consultants, and those coordinating with external AAL technology vendors.

Key Topics

The standard addresses practical, technical and organizational topics central to AAL system development and deployment:

• AAL system development process: A structured approach that uses representative use cases, reference architecture and architecture models as primary inputs to system specification and design.
• Use cases: Guidance based on IEC TS 63134 for identifying real-world AAL user needs across prevention, social interaction, mobility, health/wellness and daily living management.
• Validation and verification: Definitions and procedures to confirm that systems meet intended use (validation) and that specified requirements are fulfilled (verification).
• Safety, security and privacy: Guidance to ensure AAL systems protect users and their data throughout the system lifecycle.
• Usability and accessibility: Human factors and usability considerations to make systems effective for diverse AAL users.
• Performance and interoperability: Ensuring components from multiple vendors work together reliably.
• Regulatory and standards alignment: Processes for tracking applicable international standards and local/global regulatory requirements and documenting compliance efforts.
• Service organization responsibilities: Roles for design, implementation, policy development, approvals and lifecycle maintenance.

Applications

IEC SRD 63219:2022 is practical for a range of real-world activities:

• Designing or procuring AAL systems that integrate sensors, devices, software and services.
• Implementing installations in homes, care facilities or community settings with focus on user safety and privacy.
• Creating verification and validation plans to support internal approval, risk management and vendor acceptance.
• Maintaining systems throughout their service life, including updates to keep pace with standards and regulations.
• Coordinating multi-vendor interoperability and documenting evidence for certification or audits.

Who will use it: AAL service providers, systems integrators, procurement teams, installers, healthcare IT managers, human factors specialists and compliance officers.

Related standards

• IEC TS 63134 (AAL use cases) is a direct complement referenced in the SRD.
• Annexes in IEC SRD 63219 point to international standards on usability, human factors and risk management; users should consult the normative references and local regulations and confirm the latest editions.

Keywords: IEC SRD 63219:2022, active assisted living, AAL system development, AAL service providers, validation, verification, usability, safety, security, interoperability.

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
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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 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
IEC TS 63134:2020, Active assisted living (AAL) use cases
3 Terms and definitions
For the purposes of this document, the terms and definitions in given in IEC TS 63134:2020
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
AAL
active assisted living
concepts, products, services, and systems combining technologies and social environment with
the aim of improving the quality of people's lives
[SOURCE: IEC 60050-871:2018, 871-01-02, modified – The deprecated term "ambient assisted
living" has been omitted.]
– 8 – IEC SRD 63219:2022 © IEC 2022
3.2
AAL service organization
organization responsible for ensuring that the AAL system meets the needs of the AAL user
Note 1 to entry: An AAL service organization comprises AAL service provider employees, contractors, agents, and
healthcare consultants responsible for using, installing, and supporting AAL systems.
3.3
residual risk
risk remaining after risk reduction measures have been implemented
[SOURCE: ISO/IEC Guide 51:2014, 3.8]
3.4
validation
confirmation, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
[SOURCE: ISO 9000:2015, 3.8.13, modified – Notes to entry have been omitted.]
3.5
verification
confirmation, through the provision of objective evidence, that specified requirements have
been fulfilled
[SOURCE: ISO 9000:2015, 3.8.12, modified – Notes to entry have been omitted.]
3.6
service life
the period from initial operation to final withdrawal from service of a structure, system, or
component
[SOURCE: IEC 60737:2010, 3.6, modified – Note to entry has been omitted.]
4 AAL service organization responsibilities
The AAL service organization is responsible for:
a) developing or reviewing the AAL
...