YY/T 0696-2021Test method for measuring output characteristics of nerve and muscle stimulators (English PDF)
神经和肌肉刺激器输出特性的测量
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
May 1, 2023
Scope
YY/T 0696-2021 is the English-translated version of 神经和肌肉刺激器输出特性的测量.
YY/T 0696-2021 is the Chinese pharmaceutical industry standard that gives the method for measuring the output characteristics of nerve and muscle stimulators, the equipment within the scope of YY 9706.210-2021.
It sets out the measuring circuit and the load used, how the output voltage and current waveforms are recorded, and how the quantities that describe them - the pulse amplitude, duration, shape and repetition rate, and the energy or charge delivered per pulse - are derived, so that the figures a manufacturer declares for a stimulator can be verified in the same way everywhere.
It replaces YY/T 0696-2008, was issued on 9 March 2021 and has applied since 1 May 2023.
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Document preview — YY/T 0696-2021
National Standard of the People's Republic of China
- Classification
- C 42
- Replacing
- YY/T 0696-2008
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0696-2008 "Measurement of the output characteristics of nerve and muscle stimulators", compared with YY/T 0696-2008, In addition to editorial changes, the main changes are as follows.
--- Deleted the 5s average effective value in terms and definitions (3.2 in the.2008 edition);
---Added the 1s average effective value in terms and definitions (see 3.2);
---Modified the pulse energy in terms and definitions (see 3.3, 3.3 in the.2008 edition);
---Modified the requirements of test equipment (see 4.2, 4.2 of the.2008 edition);
---Modified the current density test method (see 5.2, 5.2 of the.2008 edition);
---Deleted the test method of output amplitude (5.3 in.2008 edition);
---Modified the pulse energy test method (see 5.3, 5.4 of the.2008 edition);
--- Deleted the contents of Appendix A and Appendix B (Appendix A and Appendix B of the.2008 edition).
1 Scope
This standard specifies the measurement method for the output characteristics of equipment within the scope of YY 9706.210-2021.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1 Medical Electrical Equipment Part 1: General Requirements for Safety
YY 9706.210-2021 Medical electrical equipment Part 2-10.Basic safety and basic performance of nerve and muscle stimulators Use requirements
3 Terms and definitions
The following terms and definitions defined in GB 9706.1 and YY 9706.210-2021 apply to this document.
3.1 Effective value (subscript q) rmsvalue(subscript.q)
The square root of the average of the squares of the instantaneous values of a quantity in a specified time interval. For the period amount, the time interval is one cycle.
For n quantities x1, x2,, xn, the positive square root of the average of its squares (squares), see formula (1). (x21 x22 x2n) êê úú 1/2 (1)
For the quantity x that depends on the variable t, the positive square root of the average value of the square of the quantity at a given interval of the variable, see equation (2). Tintegral t0 T [x(t)]2dté êê úú 1/2 (2)
3.2 1s average effective value
For time-dependent variables, the effective value obtained on any integral time of 1s.
Note. Unless otherwise specified, the "effective value of voltage" and "effective value of current" used in this document refer to the 1s average effective value of voltage or current.
3.3 Pulseenergy
The energy of a single pulse. Calculate by formula (3) or formula (4).
- Tw ÷ (3) Where. E --- pulse energy; Ip --- the current peak value of the measured pulse;
R ---The load resistance required by.201.12.4.104 in YY 9706.210-2021 is 500ohm;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
Similar standards
Editions of YY/T 0696
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0696-2021 | Test method for measuring output characteristics of nerve and muscle stimulators | current edition | Current |
| YY/T 0696-2008 | Test method for measuring output characteristics of nerve and muscle stimulators | previous edition | Superseded |
This page sells the current edition, YY/T 0696-2021. Earlier editions are listed for reference only.
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
YY 9706.210-2021 — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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