ISO 19611-2017 PDF

Full title and description

ISO 19611:2017 — Traditional Chinese medicine — Air extraction cupping device. This International Standard specifies requirements and test methods for air-extraction (negative-pressure) cupping devices, covering materials, pressure performance, sterilization or disinfection, and packaging; it applies to both single‑use and multiple‑use types and excludes the suction pump used to generate negative pressure.

Abstract

ISO 19611:2017 sets out essential safety and performance requirements for air extraction cupping devices used in traditional Chinese medicine practice, together with associated test methods. The standard addresses materials, construction, required negative-pressure characteristics, requirements for sterilization or disinfection (as applicable), and packaging/marking for safe use. It is intended for both disposable (single‑use) and reusable devices; the suction pump creating negative pressure is outside the scope.

General information

• Status: Published (under ISO review lifecycle; records of committee activity toward revision exist).
• Publication date: May 2017 (2017-05).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.99 (Traditional Chinese medicine).
• Edition / version: Edition 1 (2017).
• Number of pages: ISO lists 9 pages for the published International Standard; some national/adopted versions or catalogues list extended PDF/page counts (commonly 16–20 pages) depending on national formatting.

Scope

Specifies requirements and test methods for air extraction cupping devices that operate using negative pressure. Applies to single‑use and multiple‑use cupping devices. Excludes the suction pump used to create the negative pressure. Covers material selection, construction, pressure/performance characteristics, sterilization/disinfection requirements, labelling and packaging to ensure safe, hygienic use in traditional Chinese medicine practice.

Key topics and requirements

• Definitions and classification — single‑use vs. reusable (multiple‑use) devices.
• Material and construction requirements to ensure biocompatibility, durability and cleanability (for reusable types).
• Negative‑pressure (vacuum) performance and test methods — required pressure ranges and measurement procedures.
• Requirements for sterilization or disinfection, including marking and instructions for the chosen processing method.
• Packaging and labelling — information to users about safe use, single‑use/reuse status, sterilization state and warnings.
• Exclusion note: requirements do not cover the suction pump that generates negative pressure.

Typical use and users

Primary users include manufacturers and designers of cupping devices, regulatory and conformity‑assessment bodies, testing laboratories, procurement/specification teams in healthcare and traditional medicine clinics, and practitioners of traditional Chinese medicine who need to understand device safety, cleaning/sterilization and labelling requirements. Also relevant for importers and product compliance specialists.

Related standards

Relevant associated standards and normative references commonly used alongside ISO 19611 include ISO 13485 (medical devices — quality management systems), ISO 10993 series (biological evaluation of medical devices), ISO 14971 (risk management for medical devices), and standards covering sterilization/processing such as ISO 17664 and ISO 11135 where applicable; national medical device regulations and sector‑specific guidance may also apply. Additionally, other ISO/TC 249 deliverables on traditional Chinese medicine can be relevant for terminology and practice context.

Keywords

air extraction cupping device, cupping, traditional Chinese medicine, negative pressure, vacuum cupping, single‑use, reusable, sterilization, disinfection, packaging, test methods, ISO 19611.

FAQ

Q: What is this standard?

A: ISO 19611:2017 is an International Standard that defines safety, performance and testing requirements for air extraction (negative‑pressure) cupping devices used in traditional Chinese medicine.

Q: What does it cover?

A: It covers materials, construction, negative‑pressure performance requirements and test methods, sterilization/disinfection considerations, labelling and packaging for both single‑use and reusable cupping devices. It explicitly excludes the suction pump that creates the negative pressure.

Q: Who typically uses it?

A: Manufacturers, product designers, conformity assessors, test laboratories, practitioners and clinics (for procurement and safe‑use information), and regulators or compliance teams involved with traditional medicine devices.

Q: Is it current or superseded?

A: The standard was published in May 2017 and is listed as a published International Standard. ISO records indicate periodic review and there has been committee activity toward revision (committee drafts/DIS entries appear in ISO records and some tracked project entries have shown changes in status), so users should check the ISO catalogue or their national standards body for the latest revision activity or any replacement.

Q: Is it part of a series?

A: It is a standalone ISO document specific to air extraction cupping devices, published under the work of ISO/TC 249 (Traditional Chinese medicine). Related ISO/TC 249 publications address other aspects of traditional Chinese medicine practice and terminology but ISO 19611 itself is a single‑subject standard.

Q: What are the key keywords?

A: air extraction cupping device; cupping; traditional Chinese medicine; negative pressure; sterilization; disinfection; single‑use; reusable; test methods; packaging.