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YY/T 1928-2023Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment (English PDF)

预期用于磁共振环境的医用电气设备的术语和分类

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

November 22, 2023

Implementation date

December 1, 2024

Scope

YY/T 1928-2023 is the English-translated version of 预期用于磁共振环境的医用电气设备的术语和分类.

YY/T 1928-2023 is the Chinese standard "Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment".

Its scope clause reads: This document defines the terminology for medical electrical equipment intended for use in a magnetic resonance environment and specifies the Classification of gas equipment.

This document applies to medical electrical equipment used in a magnetic resonance environment. Its clauses include terms and definitions.

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Document preview — YY/T 1928-2023

National Standard of the People's Republic of China

ICS: 11.040.01
Classification: C30

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Category
Appendix A (Normative) Safety marking requirements for magnetic resonance environments
Appendix B (Informative) Examples of marking of medical devices that are safe for magnetic resonance conditions
Appendix C (Informative) Additional Notes on Magnetic Resonance Environment Safety

1 Scope

This document defines the terminology for medical electrical equipment intended for use in a magnetic resonance environment and specifies the

Classification of gas equipment.

This document applies to medical electrical equipment used in a magnetic resonance environment.

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document.

3.1 Magnetic resonance; MR

The phenomenon of resonance absorption of electromagnetic field energy of a specific frequency by a group of atomic nuclei placed in a magnetic field.

NOTE. In this document, the magnetic field generally refers to the composite field of the static magnetic field and the gradient field of the magnetic resonance equipment used for medical diagnosis.

[Source. YY 9706.233-2021,.201.3.217, modified]

3.2 MRequipment

Medical electrical equipment intended for magnetic resonance imaging of humans (3.5), including all hardware and software from the mains power supply to the display monitor part.

[Source. YY 9706.233-2021,.201.3.218, modified]

3.3 MR system

The combination of magnetic resonance equipment (3.2), accessories (including display, control and energy supply devices) and controlled access area (if any).

[Source. YY 9706.233-2021,.201.3.220]

3.4 MRenvironment

The three-dimensional volume of space around the magnetic resonance device (3.2), which includes the volume of space inside the Faraday shield and the volume of space inside the 0.5 mT

The spatial volume within the contour of the magnetic field contour (5 Gauss line). This three-dimensional spatial volume refers to the exposure of the medical device to the magnetic resonance equipment and its accessories

Areas where electromagnetic fields may cause danger.

[Source. ASTM F2503-20, 3.1.10, modified] […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 29 pages — is available in the English PDF.

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