Traditional Chinese medicine -- Glass cupping device

This document specifies the requirements for the glass cupping device applying negative pressure created by a heat source placed in its inner cavity. This document includes the requirements for configuration, material, performance, packaging and labelling, as well as appropriate test methods. This document applies to single-use and multiple-use glass cupping devices. This document does not apply to the air extraction cupping device covered by ISO 19611.

Médecine traditionnelle chinoise -- Ventouses en verre

General Information

Status
Published
Publication Date
27-Aug-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
24-Jul-2020
Completion Date
23-Jul-2020
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INTERNATIONAL ISO
STANDARD 22213
First edition
2020-08
Traditional Chinese medicine — Glass
cupping device
Médecine traditionnelle chinoise — Ventouses en verre
Reference number
ISO 22213:2020(E)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 22213:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22213:2020(E)
Contents Page

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

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

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

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

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

4 Specification .............................................................................................................................................................................................................. 2

4.1 Configuration ............................................................................................................................................................................................ 2

4.2 Dimensions and parameters ....................................................................................................................................................... 2

4.2.1 General...................................................................................................................................................................................... 2

4.2.2 Volume of the inner cavity ....................................................................................................................................... 3

4.2.3 Glass thickness................................................................................................................................................................... 3

4.3 Material ......................................................................................................................................................................................................... 3

5 Requirements .......................................................................................................................................................................................................... 3

5.1 Biological compatibility................................................................................................................................................................... 3

5.2 Surface smoothness ............................................................................................................................................................................ 3

5.3 Glass quality .............................................................................................................................................................................................. 3

5.4 Performance .............................................................................................................................................................................................. 4

5.4.1 Negative pressure resistance ................................................................................................................................ 4

5.4.2 Pressure maintenance ................................................................................................................................................. 4

5.4.3 Test methods ....................................................................................................................................................................... 4

5.5 Sterilization and disinfection ...................................................................................................................................................... 4

6 Package ........................................................................................................................................................................................................................... 4

6.1 Primary package .................................................................................................................................................................................... 4

6.2 Secondary package .............................................................................................................................................................................. 4

7 Labelling ........................................................................................................................................................................................................................ 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Primary package .................................................................................................................................................................................... 5

7.3 Secondary package .............................................................................................................................................................................. 5

7.4 Storage and transit package ........................................................................................................................................................ 5

Annex A (informative) Test methods for a glass cupping device ............................................................................................. 6

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 22213:2020(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 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.

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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 22213:2020(E)
Introduction

Cupping therapy has been widely used since ancient times. The glass cupping device is one of the most

commonly used types of cupping devices. The quality of the glass cupping device has a direct impact on

its safe use and influences the therapeutic efficacy. This document was developed to improve the safety

and quality of the glass cupping device.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 22213:2020(E)
Traditional Chinese medicine — Glass cupping device
1 Scope

This document specifies the requirements for the glass cupping device applying negative pressure

created by a heat source placed in its inner cavity.

This document includes the requirements for configuration, material, performance, packaging and

labelling, as well as appropriate test methods.
This document applies to single-use and multiple-use glass cupping devices.

This document does not apply to the air extraction cupping device covered by ISO 19611.

2 Normative references
The following documents are referred to in t
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22213
ISO/TC 249
Traditional Chinese medicine — Glass
Secretariat: SAC
cupping device
Voting begins on:
2020­05­28
Voting terminates on:
2020­07­23
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 22213:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 22213:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 22213:2020(E)
Contents Page

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

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

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

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

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

4 Specification .............................................................................................................................................................................................................. 2

4.1 Configuration ............................................................................................................................................................................................ 2

4.2 Dimensions and parameters ....................................................................................................................................................... 2

4.2.1 General...................................................................................................................................................................................... 2

4.2.2 Volume of the inner cavity ....................................................................................................................................... 3

4.2.3 Glass thickness................................................................................................................................................................... 3

4.3 Material ......................................................................................................................................................................................................... 3

5 Requirements .......................................................................................................................................................................................................... 3

5.1 Biological compatibility................................................................................................................................................................... 3

5.2 Surface smoothness ............................................................................................................................................................................ 3

5.3 Glass quality .............................................................................................................................................................................................. 3

5.4 Performance .............................................................................................................................................................................................. 4

5.4.1 Negative pressure resistance ................................................................................................................................ 4

5.4.2 Pressure maintenance ................................................................................................................................................. 4

5.4.3 Test methods ....................................................................................................................................................................... 4

5.5 Sterilization and disinfection ...................................................................................................................................................... 4

6 Package ........................................................................................................................................................................................................................... 4

6.1 Primary package .................................................................................................................................................................................... 4

6.2 Secondary package .............................................................................................................................................................................. 4

7 Labelling ........................................................................................................................................................................................................................ 4

7.1 General ........................................................................................................................................................................................................... 4

7.2 Primary package .................................................................................................................................................................................... 5

7.3 Secondary package .............................................................................................................................................................................. 5

7.4 Storage and transit packages ...................................................................................................................................................... 5

Annex A (informative) Test methods for a glass cupping device ............................................................................................. 6

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2020 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 22213:2020(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 non­governmental, 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 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.

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.
iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 22213:2020(E)
Introduction

Cupping therapy has been widely used since ancient times. The glass cupping device is one of the most

commonly used types of cupping devices. The quality of the glass cupping device has a direct impact on

its safe use and influences the therapeutic efficacy. This document was developed to improve the safety

and quality of the glass cupping device.
© ISO 2020 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 22213:2020(E)
Traditional Chinese medicine — Glass cupping device
1 Scope

This document specifies the requirements for the glass cupping device applying negative pressure

created by a heat source placed in its inner cavity.

This document includes the requirements for configuration, material, performance, packaging and

labelling, as well as approp
...

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