International meeting for ISO standard development
on traditional medical devices
More than 40 experts on traditional medical devices from Korea, China and Japan
participated to discuss ISO standard development
on computerized tongue image analysis system, measurement of pulse parameter, etc.
KIOM held the 11th international meeting of ISO/TC249/WG4 (Quality and safety of medical devices other than acupuncture needles) in Seoul from January 25 to 26.
ISO/TC249/WG4 is an ISO working group for the development of ISO standards on medical devices in traditional medicine, and is currently chaired by Director Choi Sunmi of the KM Standards Center in KIOM. The meeting was attended by about 40 experts on the international standards of traditional medicine from Korea, China and Japan.
※ ISO/TC249/WG4: An ISO working group that deals with the quality and safety of medical devices other than acupuncture needles in the technical committee of traditional Chinese medicine
The 11th meeting focused on in-depth discussion on the computerized tongue image analysis system, laser acupoint radiation device, abdominal physiological parameter detector, etc., for which the establishment of standards is being sought at present, along with introduction to new proposals to develop international standards.
In the morning session on the first day of the meeting, detailed discussion was made on the standards regarding the color chart and peripheral visual instruments for computerized tongue image analysis system jointly being developed by Korea, China and Japan, as well as ‘method of acquisition and expression of tongue colour and tongue coating colour’ based on the tongue image analysis system proposed by China.
In the afternoon session, participants actively exchanged opinions on the development of standards for traditional medical devices including the laser acupoint radiation device and the abdominal physiological parameter detector.
On the second day of the meeting, presentations were made on the necessity of developing these standards and technical explanations on ‘guidelines for measurement on pulse parameter used by electric radial tonometry device’ and ‘consecutive acupuncture needles inserter’ proposed as new standards by Korea.
After the meeting ended, the participants visited KyungHee University Korean Medicine Hospital to learn about the current status of clinical practices in Korean medicine.
Dr. Choi, the convener of ISO/TC249/WG4, said, “The interest in traditional medical devices is increasing around the world, and a lot of efforts are being made for the development of high-quality standards for medical devices through international cooperation. It is expected to ensure safety and quality of medical device in traditional medicine and to contribute to their promotion in the global market.”
ISO/TC249, founded in 2009, is the technical committee dedicated to the establishment of international standards in the field of traditional medicine. WG4 has established six ISO standards for medical devices including cupping device and moxibustion, and is currently developing 13 international standards on electric radial pulse tonometric devices, computerized tongue image analysis system, etc.