ISO 19611:2017
(Main)Traditional Chinese medicine — Air extraction cupping device
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
Standards Content (Sample)
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
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ISO 19611:2017(E)
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© ISO 2017, Published in Switzerland
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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).
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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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