YY 9706.210-2021Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (English PDF)
医用电气设备 第2-10部分：神经和肌肉刺激器的基本安全和基本性能专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
March 9, 2021
Implementation date
May 1, 2023
Scope
YY 9706.210-2021 is the English-translated version of 医用电气设备 第2-10部分：神经和肌肉刺激器的基本安全和基本性能专用要求.
YY 9706.210 is the mandatory Chinese standard for nerve and muscle stimulators, the class that runs from clinical electrotherapy and TENS units to the muscle stimulation devices sold for rehabilitation and fitness. It sets the particular requirements for basic safety and essential performance on top of the general medical electrical safety standard, covering the output current and voltage and the limits on charge delivered per pulse, the electrode and the current density at the skin, the protection against a sudden increase in output, and the warnings about use near the heart or on a patient with an implanted device. The consumer end of this market is large in China and largely unsupervised, which is what the mandatory floor is for. It took effect in May 2023.
Document preview — YY 9706.210-2021
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
Foreword
This document was issued on 9 March 2021 by the National Medical Products Administration and takes effect on 1 May 2023.
It is a YY standard without the /T suffix: compliance is mandatory in China.
1 Scope
YY 9706.210 is the mandatory Chinese standard for nerve and muscle stimulators, the class that runs from clinical electrotherapy and TENS units to the muscle stimulation devices sold for rehabilitation and fitness. It sets the particular requirements for basic safety and essential performance on top of the general medical electrical safety standard, covering the output current and voltage and the limits on charge delivered per pulse, the electrode and the current density at the skin, the protection against a sudden increase in output, and the warnings about use near the heart or on a patient with an implanted device. The consumer end of this market is large in China and largely unsupervised, which is what the mandatory floor is for. It took effect in May 2023.
Remaining clauses in the full document
- 2 Normative references
- 3 Terms and definitions
- About this edition
- Classification and status
- How a Chinese national standard is set out
- About this English translation
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
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YY 9706.210-2021
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