National foreword

This British Standard is the UK implementation of ISO 5363:2024.

The UK participation in its preparation was entrusted to Technical Committee AMT/10, Robotics.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2024.

Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of document should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives or www.iec.ch/members_experts/refdocs).

ISO and IEC draw attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO and IEC take no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO and IEC had received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents and https://patents.iec.ch. ISO and IEC shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html. In the IEC, see www.iec.ch/understanding-standards.

This document was prepared jointly by Technical Committee ISO/TC 299, Robotics, and Technical Committee IEC/TC 62, Medical equipment, software, and systems, Subcommittee SC 62A, Common aspects of medical equipment, software, and systems and Subcommittee SC 62D, Particular medical equipment, software, and systems.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html and www.iec.ch/national-committees.

Introduction

When IEC 80601‑2‑78:2019 was published there were no specific test methods to verify the conformity with the standard. This document was developed to supplement IEC 80601‑2‑78:2019 by specifying test methods to evaluate powered exoskeleton-type walking RACA robots.

1 Scope

This document specifies test methods for the exoskeleton-type walking RACA robot used as medical electrical equipment which is intended to move from one location to another, by making reciprocating motion having intermittent contact with the travel surface.

This document does not apply to passive or non-powered exoskeletons.

NOTE These tests can be used to verify conformity with the requirements of IEC 80601‑2‑78.

2 Normative references

3 Terms and definitions

4 Test conditions

4.1 General

4.2 Environmental conditions

4.3 Apparatus

4.4 Example of test setup

5 Accuracy test of range of movement of each joint of walking RACA robot

5.1 Purpose

5.2 Procedure

6 Repeated durability test of actuated applied part

6.1 Purpose

6.2 Procedure

7 Repeated durability test of support system of walking RACA robot

7.1 Purpose

7.2 Procedure

8 Test report

Bibliography

BS ISO 5363:2024

Robotics. Test methods for exoskeleton-type walking RACA robot

Current

Published:

31 May 2024