ISO 5227:2022

Traditional Chinese medicine — Safety controls for cupping devices

This document specifies safety controls for cupping devices used for air suction or discharge. It applies to cupping devices that contain cups made of manufactured materials, such as plastic, glass, rubber, ceramic or silicone. It does not apply to cupping devices that contain cups made from natural materials (e.g. bamboo) or those that include additional features, such as magnetism or infrared.

Médecine traditionnelle chinoise — Contrôles de sécurité pour les ventouses

General Information

• Status: Published
• Publication Date: 27-Nov-2022
• ICS: 11.040.60 - Therapy equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 4 - Quality and safety of medical devices other than acupuncture needles
• Current Stage: 6060 - International Standard published
• Start Date: 28-Nov-2022
• Due Date: 25-Aug-2023
• Completion Date: 28-Nov-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 5227
First edition
2022-11
Traditional Chinese medicine — Safety
controls for cupping devices
Médecine traditionnelle chinoise — Contrôles de sécurité pour les
ventouses
Reference number
ISO 5227:2022(E)
© ISO 2022

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ISO 5227:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 5227:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
4 R e qu i r ement s . 2
4.1 S afety controls before use . 2
4.1.1 Design and manufacture of cupping devices . 2
4.1.2 Restrictions of reuse . 2
4.1.3 Sterility of cupping devices used for wet cupping . 2
4.1.4 Cleaning and disinfection of cupping devices used for dry cupping . 2
4.1.5 Visual test . 2
4.1.6 Checking package, label, user manual and attached leaflets . 2
4.2 S afety controls after use . 3
4.2.1 D isposal of cupping devices used for wet cupping. 3
4.2.2 C leaning and disinfection of cupping devices used for dry cupping . 3
5 Safety control verification . 3
Annex A (informative) Checklist for safety control verification . 4
Bibliography . 5
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ISO 5227:2022(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
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electrotechnical standardization.
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 ISO documents 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).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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.
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ISO 5227:2022(E)
Introduction
Cupping therapy is one of the most widely used traditional medical practices. It involves creating
a partial vacuum in cups placed on the skin for air suction or to extract the blood through various
techniques. Even though cupping devices are marketed and used in many countries, there is no
International Standard for safety controls for cupping devices. Such controls are needed to ensure
the safety of cupping devices, which touch the skin or come into contact with open wounds during
bleeding for wet cupping. These controls require the risk management of manufacturing, packaging
and labelling and the presentation, storage, reuse, servi
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