ISO 19611:2017

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
• ICS: 11.040.99 - Other medical equipment
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9092 - International Standard to be revised
• Start Date: 19-Jan-2023
• Completion Date: 13-Dec-2025

Overview

ISO 19611:2017 - Traditional Chinese medicine - Air extraction cupping device - defines safety, performance and packaging requirements for air extraction cupping devices that operate using negative pressure. The standard covers materials, dimensions, pressure performance, sterilization/disinfection, labelling and test methods, and applies to both single‑use and multiple‑use cupping cups. (The suction pump that creates negative pressure is excluded.)

Key topics and technical requirements

• Scope & configuration

  • Defines parts: body, air outlet and one‑way valve; specifies inner volume classes (e.g., 70 ±7 ml, 55 ±5.5 ml, 40 ±4.0 ml, 25 ±2.5 ml, 15 ±1.5 ml).
  • Air outlet must include an outer diameter portion of at least 11 mm.
  • Skin‑contacting edge must be rounded to prevent injury; transparency required to observe skin changes.

• Performance

  • Negative pressure resistance: device must resist a maximum instantaneous negative pressure (specified in the standard).
  • Pressure maintenance: pressure must be maintained over time (standard requires limited pressure loss over 10 minutes).
  • Mechanical stability: maintain pressure after impact testing (0.5 J ±0.05 J).
  • Repeated disinfection resistance: multiple‑use devices must retain performance after repeated disinfection.

• Biological safety

  • Biological evaluation per ISO 10993 series. Required tests vary by type:
    • Both single‑use and multiple‑use: cytotoxicity and sensitization.
    • Single‑use (blood‑contact) additionally: intracutaneous reactivity, acute systemic toxicity, hemocompatibility.
    • Ethylene oxide (EO) residual testing when EO sterilization is used.

• Sterilization & disinfection

  • Single‑use devices: validated sterilization per ISO 11135 / ISO 11137‑1 / ISO 17665‑1.
  • Multiple‑use devices: validated disinfection procedures per ISO 17664.

• Packaging & labelling

  • Primary package must be sealed, free of foreign matter, protect sterility/disinfection and show evidence of opening.
  • Symbols and labelling follow ISO 15223‑1; secondary packaging must protect contents during transport/storage.

Applications and users

ISO 19611 is intended for:

• Manufacturers and designers of cupping devices (product specification, testing and CE/market compliance).
• Quality assurance, regulatory affairs and conformity assessment teams in medical device companies.
• Sterilization and reprocessing specialists defining validated processes.
• Healthcare providers, clinics and procurement teams that purchase single‑use or reusable cupping cups.
• Test laboratories performing performance and biocompatibility testing.

Related standards

• ISO 10993 (biological evaluation)
• ISO 11135, ISO 11137‑1, ISO 17665‑1 (sterilization)
• ISO 17664 (reprocessing information)
• ISO 15223‑1 (symbols on labels)
• ISO 11607‑1 (packaging for terminally sterilized devices)

Keywords: ISO 19611, air extraction cupping device, cupping therapy, traditional Chinese medicine, negative pressure, sterilization, biocompatibility, medical device packaging.

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 2017
© 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
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
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ii © ISO 2017 – All rights reserved

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

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.
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
...