BS ISO 19611:2017,Traditional Chinese medicine – Air extraction cupping device.
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, Schropfkopf 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.
BS ISO 19611:2017 specifies requirements for an air extraction cupping device which operates using negative pressure.
BS ISO 19611:2017 includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods.
BS ISO 19611:2017 is applicable to single-use type and multiple-use type devices.
4. 2.2 Smoothness of the skin contacting edge
The skin contacting edge of the body of the cupping device shall be sufficiently rounded to prevent injury in the surface of the skin during the cupping treatment. The roundness of the skin contacting edge shall be assessed by visual inspection.
4.2.3 Diameters of air outlet
The air outlet shall at least have a portion of its outer diameter measuring 11 mm.
5 Requirements
5.1 Biological compatibility
The body of the cupping device intended to be exposed to blood during the bloodletting cupping technique shall be assessed and documented according to the guidance and principles given in the ISO 10993 series.