About the Japanese Standards Association Group
As a national centre for Standardisation, the Japanese Standards Association Group (JSA Group) works to develop draft Japanese Industrial Standards (JIS) in various fields.
The JSA Group conducts surveys and research into Standardisation, while investigating and studying the application and practical aspects of quality engineering (Taguchi Methods), data analysis methods, and techniques used to boost reliability and motivation.
It also helps speed up the development of Standards for domestic mainstay and small-to-medium sized companies wanting to create Standards for new markets.
IS Standards for X-Ray and Radiography
- JIS Z 3104: Methods of radiographic examination for welded joints in steel using industrial X-ray or gamma-ray films (classifies image quality into 6 sensitivity kinds and types of flaws)
- JIS Z 2306: Radiographic image quality indicators (wire-type and porous-type penetrameters/IQIs used to check sensitivity in X-ray or gamma-ray testing).
- JIS Z 4751 Series (e.g., JIS Z 4751-2-54): Medical electrical equipment and general-purpose X-ray diagnostic safety/performance requirements, matching international IEC standards for exposure accuracy and high-voltage control.
- JIS K 7618: Standards for industrial X-ray films harmonized with ISO 7004.
- JIS Z 4560: Apparatus for industrial gamma radiography (specifies performance, design, and testing, based on ISO 3999)
Diagnostic X-ray equipment management and Japanese Industrial Standards. General radiography, angiography, mammography for diagnostic equipment
Diagnostic X-ray devices are manufactured based on the Japanese Industrial Standards (JIS). This paper has picked up the contents of JIS that users should know when managing these devices. It described the accuracy of photographing time and automatic exposure control in general-purpose radiography devices, the limit of the reference air kerma rate in angiography devises, and the ripple percentage of tube voltage and X-ray output in mammography devices. The accuracy of the photographing time is defined by JIS Z 4751-2-54, but in order to correctly represent the photographing time with progress of the control technology of X-ray high-voltage devices, the tolerance review work has been carried out according to the development of X-ray high-voltage devices in face of the enactment of the JIS. The main basic characteristics of automatic exposure control are divided into subject thickness characteristics, response time characteristics, and tube voltage characteristics. The limit value of the reference air kerma rate at the time of fluoroscopy was defined as 50 mGy/min for normal fluoroscopy and 125 mGy/min for high dose rate control, taking into consideration the opinions of users considering the physical size of Japanese people and the exposure of examinees and medical staff. (A.O.)
JIS Z 4751-2-54:2021 is the Japanese Industrial Standard for the basic safety and essential performance of X-ray equipment used for radiography and radioscopy
Key Details
- Scope: Applies to medical electrical equipment and systems intended to produce diagnostic X-ray radiography and radioscopy images.
- Exclusions: Does not cover dental X-ray equipment, mammography, computed tomography (CT), bone/tissue densitometry, or radiotherapy simulators (which fall under separate standards).
- Radiation Limits (Japan):
- Maximum fluoroscopy air kerma rate is generally limited to 50 mGy/min.
- High-level control (HLC) fluoroscopy is capped at a maximum of 125 mGy/min.
- International Equivalent: Corresponds to IEC 60601-2-54.
- Standard Evolution: The earlier 2012 and 2017 versions have been superseded by the updated 2021 standard (view the full details via JIS Database on JIS eomec or reference document summaries on JSA JIS Z 4751-2-54-2012 on cntd.ru)
