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JJF 1896-2021 English PDF

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JJF 1896-2021: Calibration Specification for Electromyographs and Evoked Response Equipment
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JJF 1896-2021English459 Add to Cart 4 days [Need to translate] Calibration Specification for Electromyographs and Evoked Response Equipment Valid JJF 1896-2021

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Basic data

Standard ID JJF 1896-2021 (JJF1896-2021)
Description (Translated English) Calibration Specification for Electromyographs and Evoked Response Equipment
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A56
Word Count Estimation 20,279
Issuing agency(ies) State Administration for Market Regulation

JJF 1896-2021: Calibration Specification for Electromyographs and Evoked Response Equipment

---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.
Calibration Specification for Electromyographs and Evoked Response Equipments National Metrology Technical Specifications of the People's Republic of China Calibration specification for electromyography and evoked response equipment Released on 2021-02-23 2021-08-23 implementation Issued by the State Administration for Market Regulation Calibration specification for electromyography and evoked response equipment Focal point. National Radio Metrology Technical Committee The main drafting unit. The Pharmaceutical Instrument Inspection Institute of the Health Bureau of the Central Military Commission Logistics Support Department China Institute of Metrology Participated in the drafting. PLA 307 Hospital Inner Mongolia Autonomous Region Metrology and Testing Research Institute This specification entrusts the National Radio Measurement Technical Committee to be responsible for the interpretation The main drafters of this specification. Wu Wenjun (Drug and Instrument Inspection Institute of the Health Bureau of the Logistics Support Department of the Central Military Commission) Li Yongxue (Drug and Instrument Inspection Institute of the Health Bureau of the Central Military Commission's Logistics Support Department) He Zhao (China Institute of Metrology) Participating drafters. Jia Jiange (Drug and Instrument Inspection Institute of the Health Bureau of the Central Military Commission's Logistics Support Department) Chen Wenxia (The 307th Hospital of the People's Liberation Army) He Na (Inner Mongolia Autonomous Region Metrology and Testing Research Institute) Lan Juan (The 307th Hospital of the People's Liberation Army)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 Reference documents (1) 3 Terms and units of measurement (1) 3.1 EMG equipment (1) 3.2 Induced response equipment (1) 3.3 Electric stimulator (1) 4 Overview (1) 5 Measurement characteristics (2) 5.1 Waveform amplitude (2) 5.2 Wave frequency (2) 5.3 Common mode rejection ratio (2) 5.4 Amplitude-frequency characteristics (2) 5.5 Stimulus signal frequency (2) 5.6 Stimulus signal intensity (2) 5.7 Stimulation pulse width (2) 6 Calibration conditions (2) 6.1 Environmental conditions (2) 6.2 Measurement standards and other equipment (2) 7 Calibration items and calibration methods (3) 7.1 Appearance and working normality inspection (3) 7.2 Wave amplitude (3) 7.3 Wave frequency (4) 7.4 Common mode rejection ratio (4) 7.5 Amplitude frequency characteristics (5) 7.6 Stimulus signal frequency(5) 7.7 Stimulus signal strength (6) 7.8 Stimulation pulse width (6) 8 Calibration result expression (6) 9 Re-calibration interval (7) Appendix A Original Record Format (8) Appendix B Format of the inner page of the calibration certificate (10) Appendix C Examples of Evaluation of Calibration Uncertainty for Major Items (12)

Introduction

This specification is based on JJF 1071-2010 "Rules for the Compilation of National Metrology and Calibration Specifications" and JJF 1059.1-2012 "Evaluation and Expression of Measurement Uncertainty" was compiled. The main technical basis of this specification is YY0896-2013 "Medical Electrical Equipment Part 2.Electromyography and Induced Special requirements for the safety of reaction equipment. This specification is released for the first time. Calibration specification for electromyography and evoked response equipment

1 Scope

EMG and evoked response equipment includes EMG equipment and evoked response equipment. This specification applies to EMG and evoked response equipment. The calibration of the equipment (only for the electrical stimulation part).

2 Reference documents

The following documents are cited in this specification. YY0896-2013 Medical electrical equipment Part 2.Special requirements for the safety of electromyography and evoked response equipment For dated reference documents, only the dated version applies to this specification; for all undated references The latest version (including all amendments) is applicable to this specification.

3 Terms and units of measurement

The following terms and definitions defined in YY0896-2013 are applicable to this specification. 3.1 Electromyograph [YY0896-2013,2.1.101] Medical electrical equipment used to detect and analyze bioelectrical potentials related to nerve and muscle activity. The activity may be spontaneous, or it may be stimulated by electricity or other stimuli. 3.2 Evoked response equipment [YY0896-2013,2.1.102] Medical electrical equipment used to detect and analyze the bioelectric potential generated by induced stimuli. The stimulus may be electric shock or touch. Touch, hearing, sight, smell, etc. 3.3 Electricalstimulator electricalstimulator[YY0896-2013,2.1.103] Device parts that conduct current by using electrodes that are in direct contact with the patient, used to stimulate biopotential or other reaction.

4 overview

Electromyography equipment and evoked response equipment use electrodes to obtain the muscle telecommunication induced by the body itself or the stimulator. No., a device that displays after being amplified by a signal amplifier and processed by an operational controller. Clinically, it is mainly used to treat God The system and muscle function are evaluated to determine the location, nature and extent of related diseases. Electrical stimulators and signals The amplifier is its core component. The structural block diagram is shown as in Fig. 1. Figure 1 Block diagram of electromyography equipment and evoked response equipment

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