Traditional Chinese medicine — Air extraction cupping device

ISO 19611:2017 specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods. ISO 19611:2017 is applicable to single-use type and multiple-use type devices. ISO 19611:2017 does not apply to the suction pump used to create the negative pressure.

Médecine traditionnelle chinoise — Dispositif de bombement à extraction d'air

General Information

Status
Published
Publication Date
22-May-2017
Current Stage
9092 - International Standard to be revised
Completion Date
19-Jan-2023
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ISO 19611:2017 - Traditional Chinese medicine -- Air extraction cupping device
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INTERNATIONAL ISO
STANDARD 19611
First edition
2017-05
Traditional Chinese medicine — Air
extraction cupping device
Médecine traditionnelle chinoise — Dispositif de bombement à
extraction d’air
Reference number
ISO 19611:2017(E)
ISO 2017
---------------------- Page: 1 ----------------------
ISO 19611:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

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ii © ISO 2017 – All rights reserved
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ISO 19611:2017(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Configuration ........................................................................................................................................................................................................... 2

4.1 Configuration of cupping device .............................................................................................................................................. 2

4.2 Dimensions ................................................................................................................................................................................................. 3

4.2.1 Inner volume ....................................................................................................................................................................... 3

4.2.2 Smoothness of the skin contacting edge ..................................................................................................... 4

4.2.3 Diameters of air outlet ................................................................................................................................................ 4

5 Requirements .......................................................................................................................................................................................................... 4

5.1 Biological compatibility................................................................................................................................................................... 4

5.2 Performance requirements .......................................................................................................................................................... 4

5.2.1 Resisting negative pressure .................................................................................................................................... 4

5.2.2 Pressure maintenance ................................................................................................................................................. 4

5.2.3 Mechanical stability ...................................................................................................................................................... 5

5.2.4 Transparency ...................................................................................................................................................................... 5

5.2.5 Repeated disinfection resistance ....................................................................................................................... 5

5.3 Sterilization and disinfection ...................................................................................................................................................... 5

5.3.1 Sterilization for single-use type devices ...................................................................................................... 5

5.3.2 Disinfection for multiple-use type devices ................................................................................................ 5

6 Package ........................................................................................................................................................................................................................... 5

6.1 Primary package .................................................................................................................................................................................... 5

6.2 Secondary package .............................................................................................................................................................................. 5

7 Labelling ........................................................................................................................................................................................................................ 6

7.1 General ........................................................................................................................................................................................................... 6

7.2 Primary package .................................................................................................................................................................................... 6

7.3 Secondary package .............................................................................................................................................................................. 6

Annex A (normative) Test methods for a cupping device ............................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2017 – All rights reserved iii
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ISO 19611:2017(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

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

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

constitute an endorsement.

For an explanation on 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 the following

URL: w w w . i s o .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2017 – All rights reserved
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ISO 19611:2017(E)
Introduction

Cupping therapy is one of the most widely used traditional medical methods, which creates a partial

vacuum in cups placed on the skin either by means of heat or mechanical devices (hand or electrical

pumps). In the Middle East, cupping therapy has been used since 1550 B.C. and widely spread by

Muhammad as Hijama. In East Asia, cupping therapy has been used since the Han dynasty and

developed to slide cupping, medicated cupping, retained cupping, etc. In Europe, cupping also has

been used since the Greek era and developed as cupping therapy in England, Schröpfkopf in German,

Ventouse in France, Vanka in Russia, etc. These days, cupping devices are commonly used in traditional

therapies through various techniques. Even though cupping device is widely used and produced in a

number of countries and companies, there is no international standard for cupping device yet. In the

aspect of safety, the cupping device directly contacts the skin, and in the case of bloodletting cupping,

it directly contacts open wounds which involves bleeding. To prevent wound infection, it should be

distinguished and developed differently in the case of intact skin or wounded skin usage. In addition, as

a medical device that directly contacts blood, it requires the use of disposable cups. The performance

requirements specified in this document are needed.
© ISO 2017 – All rights reserved v
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INTERNATIONAL STANDARD ISO 19611:2017(E)
Traditional Chinese medicine — Air extraction cupping
device
1 Scope

This document specifies requirements for an air extraction cupping device which operates using

negative pressure. This document includes requirements for the material, pressure, sterilization or

disinfection, and packaging of the cupping device, as well as appropriate test methods.

The document is applicable to single-use type and multiple-use type devices.

This document does not apply to the suction pump used to create the negative pressure.

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.

ISO 10993 (all parts), Biological evaluation of medical devices

ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,

validation and routine control of a sterilization process for medical devices

ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1: General requirements

ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the

processing of resterilizable medical devices

ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for

...

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