Standardization Division

Outline

In order to standardize medical diagnostic imaging equipment, radiotherapy equipment and radiation-related equipment, this division deliberates IEC standards and develops the corresponding JIS drafts. Its subcommittees make efforts for standardization aimed at international harmonization and its popularization.

Main activities

Standardization of medical equipment and development of JIS drafts and JESRA
(Japanese Engineering Standards of Radiological Apparatus)
Deliberation of related international standards
Holding of seminars

Organization

Standardization Division Main Committee
- Planning and Examination Committee
- Software Standard Review Committee
- Standardization Committee
  - Common general matters
    - Graphical symbols
  - X-ray equipment
    - X-ray tube/ C-ray tube device
    - X-ray equipment protection
    - Breast X-ray equipment
    - Dental X-ray unit
    - X-ray fluoroscopic / radiography equipment
    - IVR X-ray equipment
    - X-ray bone densitometer
    - X-ray I.I.
    - Image display equipment
    - Digital X-ray diagnostic imaging equipment
    - Film, intensifying paper and cassette
    - Standardization of radiation protection materials/ articles
    - Scattered X-ray removing grid
  - CT
    - X-ray CT equipment
  - MR
    - MR equipment
  - NM
    - SPECT equipment
    - PET equipment
  - US
    - Ultrasonic diagnostic equipment
  - Treatment
    - External beam radiation therapy equipment and related devices
    - After loading
    - Radiotherapy management system
    - Radiation dosimeter
    - Particle beam radiation therapy equipment
    - Image-guided radiation therapy
  - Common technological matters
    - EMC measures
  - Site design/ facility
    - Quake-resistance standards for medical diagnostic imaging equipment
    - Method of calculating operation rate of medical diagnostic imaging equipment specified in the Harmonics Control Guideline
    - Q&A on MR and attachment on magnetic resonance safe quenching system
    - Manual on X-ray shielding calculation
    - Q&A on PET facilities and revision of standardized JESRA of mobile PET facilities

Main activities

Main Committee
This committee develops annual business plans for the Standardization Division, makes budget proposals, and compiles business reports. It is responsible for its committees and makes sure each committee can promote their activities smoothly. The division head participates in the policy planning and management meeting and provide opinions on management of JIRA operations.

Planning and Examination Committee
This committee plans the activities of the division and helps promote its operations. It also examines Japanese Engineering Standards of Radiological Apparatus (JESRA) and determines whether to establish, revise, or abolish them.

Standardization Committee
This committee participates in international conferences to deliver Japan’s opinions on IEC standards related to medical equipment and systems covered by JIRA. It also prepares JIS drafts for issued IEC standards. The committee studies standardization techniques that are helpful for users and members and develops JESRA and technical materials. It also promotes standards and technologies.

Software Standard Review Committee
In cooperation with JEITA SC62A domestic committee, a domestic consultation body, this committee delivers Japan’s opinions on the handling of health software, including the software included in the medical equipment and systems covered by JIRA.