Working group on Medical Measures
Terms of Reference
Background
The Survey of Technical Infrastructure Needs of Legal Metrology in Developing Economies conducted by Dr Knut Birkeland in February-March 1996 has identified a number of priority needs to be implemented in the region. Among the many project proposals is one from Chinese Taipei on Pattern Approval and Verification of Non-invasive electronic Sphygmomanometers.
At the third Forum meeting in Vancouver, Forum members endorsed the setting up of a Working Group on Medical Measurements (proposed by Chinese Taipei) and to initiate work on sphygmomanometers.
Scope
The importance of accuracy and reliability of medical measuring instruments has been recognized, and there is a need to ensure a high degree of confidence in their usage particularly where it involves the health and safety of the individual.
At the international level, a Technical Committee on medical measuring instruments has been established by the International Organisation of Legal Metrology (OIML) to prepare International Recommendations on such instruments and to promote their implementation and pattern approval.
Sphygmomanometers (instruments for measuring blood pressure) are widely used for human medical care. Currently, there are two main types, namely mercury-in-glass sphygmomanometers and electronic ones. The Working Group will study the harmonization, pattern approval and verification of electronic sphygmomanometers.
Objectives
To ensure the accuracy and reliability of medical measuring instruments in human medication and to promote harmonization and pattern approval in the region.
Targeted Outcomes
The development of pattern approval and verification of medical measuring instruments, and as one of the priority projects, the development and pattern approval of sphygmomanometers in the region, to ensure confidence in the accuracy of medical measurements.
The Survey of Technical Infrastructure Needs of Legal Metrology in Developing Economies conducted by Dr Knut Birkeland in February-March 1996 has identified a number of priority needs to be implemented in the region. Among the many project proposals is one from Chinese Taipei on Pattern Approval and Verification of Non-invasive electronic Sphygmomanometers.
At the third Forum meeting in Vancouver, Forum members endorsed the setting up of a Working Group on Medical Measurements (proposed by Chinese Taipei) and to initiate work on sphygmomanometers.
Scope
The importance of accuracy and reliability of medical measuring instruments has been recognized, and there is a need to ensure a high degree of confidence in their usage particularly where it involves the health and safety of the individual.
At the international level, a Technical Committee on medical measuring instruments has been established by the International Organisation of Legal Metrology (OIML) to prepare International Recommendations on such instruments and to promote their implementation and pattern approval.
Sphygmomanometers (instruments for measuring blood pressure) are widely used for human medical care. Currently, there are two main types, namely mercury-in-glass sphygmomanometers and electronic ones. The Working Group will study the harmonization, pattern approval and verification of electronic sphygmomanometers.
Objectives
To ensure the accuracy and reliability of medical measuring instruments in human medication and to promote harmonization and pattern approval in the region.
Targeted Outcomes
The development of pattern approval and verification of medical measuring instruments, and as one of the priority projects, the development and pattern approval of sphygmomanometers in the region, to ensure confidence in the accuracy of medical measurements.
Membership
This WG has been supported by: Australia, Cambodia, Canada, P.R. China, Hong Kong China, Indonesia, Japan, Rep Korea, Malaysia, Mexico, Mongolia, New Zealand, Peru, Philippine, Russia, Singapore, Thailand, U.S.A, Viet Nam and Chinese Taipei.
Current Work Programme (Agreed @ 24th APLMF 2017)
- Investigating the Regulatory System and Recognized Standards for the “Non-invasive Automated Sphygmomanometer”.
- Regulatory Systems
- Health authority
- Legal metrology authority
- Recognized Standards
- GHTF SG1-N11:2008
- OIML R16-2
- Others
- Regulatory Systems
History
1999: Working was formed at the 6th APLMF
2000: Chinese Taipei assigned Dr Jay-Say Chen (BMI) Chair of WG
2014: Ms Shu-Chyin Chuang (BMI) appointed new WG Chair
2017: Mr Chung-Lin Wang (BMI) appointed new WG Chair
1999 - 2017: WG has organised 3 seminars and conducted 8 surveys on the legal measures on medical devices with measuring function.
2017/18: WG Chair Mr Chung-Lin Wang recommended the WG be disbanded and a subject matter expert be appointed.
2018: Subject Expert Appointed - Mr Jin-Hai Yang ,Technical Specialist , 2th section, 4th Division, Bureau of Standards, Metrology and Inspection(BSMI)
2000: Chinese Taipei assigned Dr Jay-Say Chen (BMI) Chair of WG
2014: Ms Shu-Chyin Chuang (BMI) appointed new WG Chair
2017: Mr Chung-Lin Wang (BMI) appointed new WG Chair
1999 - 2017: WG has organised 3 seminars and conducted 8 surveys on the legal measures on medical devices with measuring function.
2017/18: WG Chair Mr Chung-Lin Wang recommended the WG be disbanded and a subject matter expert be appointed.
2018: Subject Expert Appointed - Mr Jin-Hai Yang ,Technical Specialist , 2th section, 4th Division, Bureau of Standards, Metrology and Inspection(BSMI)
Other documents
| The Report on China's Medical Equipment Inspection Work under Legal Metrological System |