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YY/T 1928-2023 English PDF

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US$599.00 · In stock
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YY/T 1928-2023: Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1928-2023	599	Add to Cart	5 days	Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment	Valid

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Basic data

Standard ID: YY/T 1928-2023 (YY/T1928-2023)
Description (Translated English): Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.01
Word Count Estimation: 30,369
Date of Issue: 2023-11-22
Date of Implementation: 2024-12-01
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the terminology of medical electrical equipment intended to be used in the magnetic resonance environment and the classification of medical electrical equipment intended to be used in the magnetic resonance environment. This standard applies to medical electrical equipment used in magnetic resonance environments.

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.01 CCSC30 Pharmaceutical Industry Standards of the People's Republic of China Medical electrical equipment intended for use in a magnetic resonance environment Terminology and classification Released on 2023-11-22 2024-12-01 implementation The State Drug Administration issued

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Category 12 Appendix A (Normative) Safety marking requirements for magnetic resonance environments 14 Appendix B (Informative) Examples of marking of medical devices that are safe for magnetic resonance conditions 18 Appendix C (Informative) Additional Notes on Magnetic Resonance Environment Safety 21 Reference 25

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is provided by the National Technical Committee for Standardization of Medical Electrical Appliances, Medical Electronic Instruments Standardization Subcommittee (SAC/TC10/SC5) Centralized. This document was drafted by. National Medical Products Administration Medical Device Technical Evaluation Center, Shanghai Medical Device Inspection Institute, Fudan University University, Beijing Medical Device Evaluation and Inspection Center, Shenzhen Mindray Bio-Medical Electronics Co., Ltd., and Lanzhou University. The main drafters of this document are. Wang Jing, Hong Wei, Yang Pengfei, Wu Xiaomei, Chen Ran, Li Yonghua, Tao Hua, and Yao Aiping. Medical electrical equipment intended for use in a magnetic resonance environment Terminology and classification

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1928-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1928-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1928-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1928-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.