HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (12 Oct 2025)

YY/T 1095-2015 PDF English

US$165.00 · In stock · Download in 9 seconds
YY/T 1095-2015: Myoelectric Biofeedback Equipment
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid

YY/T 1095: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 1095-2015English165 Add to Cart 0-9 seconds. Auto-delivery Myoelectric Biofeedback Equipment Valid
YY/T 1095-2007English359 Add to Cart 3 days Myoelectric biofeedback equipment Obsolete

Excerpted PDFs (Download full copy in 9 seconds upon purchase)

PDF Preview: YY/T 1095-2015
      

Similar standards

YY 0950   YY 0903   YY 0900   YY/T 1306   

YY/T 1095-2015: Myoelectric Biofeedback Equipment

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1095-2015
YY PHARMACEUTICALS INDUSTRY STANDARD ICS 11.040.60 C 42 YY/T 1095-2015 Replacing YY/T 1095-2007 Myoelectric Biofeedback Equipment Issued on. MARCH 2, 2015 Implemented on. JANUARY 1, 2016 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 1 Scope... 5 2 Normative References... 5 3 Terms and Definitions... 5 4 Classification... 6 5 Requirements... 6 6 Test Methods... 10 Appendix A (Informative) Guideline and Principle of Important Clauses... 16 Bibliography... 21

Foreword

This Standard was drafted as per the rules specified in GB/T 1.1-2009. This Standard’s safety requirements fully implement the contents of GB 9706.1-2007 Medical Electrical Equipment - Part 1.General Requirements for Safety, and GB 9706.15-2008 Medical Electrical Equipment - Part 1-1.General Requirements for Safety - Collateral Standard. Safety Requirements for Medical Electrical Systems. This Standard replaces YY/T 1095-2007 Myoelectric Biofeedback Equipment. Compared with YY/T 1095-2007, this Standard mainly has the following technical differences. --- Modify this Standard’s applicable scope (see Chapter 1); --- Add the classification (see Chapter 4); --- Modify the requirements for feedback instructions and test methods (see 5.2, 6.2 of this edition; 4.2.7, 5.2 of 2007 edition); --- Add the requirements for feedback thresholds and test methods (see 5.3, 6.3); --- Add the requirements for suppression of power-frequency noise and test methods (see 5.4, 6.3); --- Delete the requirements for original measuring range and test methods (see 4.2.1, 5.3.1 of 2007 edition); --- Add the requirements for the accuracy of indicating value and test methods (see 5.5.2, 6.5.1); --- Delete the requirements for original sensitivity (see 4.2.8 of 2007 edition); --- Add the requirements for resolution and test methods (see 5.5.3, 6.5.2); --- Modify the requirements for passband and test methods (see 5.5.5, 6.5.4 of this edition; and 4.2.4, 5.3.4 of 2007 edition); --- Add the requirements for power-frequency notch filter and test methods (see 5.5.8, 6.5.7); --- Delete the requirements for original isolation (see 4.2.9 of 2007 edition); --- Add the safety requirements (see 5.8); --- Add the contents and requirements for instruction manual (see 5.7); --- Add the guideline and principle of important clauses in the informative appendix (see Appendix A). Please note some contents of this document may involve patents. The issuing agency of this document assumes no responsibility to identify these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of Subcommittee on Physical Therapy Equipment of National Technical Committee for Standardization of Medical Electrical Appliances (SAC/TC 10/SC 4). Drafting organizations of this Standard. Tianjing Medical Device Quality Supervision and Testing Center of China Food and Drug Administration. Chief drafting staffs of this Standard. Yang Guojuan, Han Mo, Duan Chuanying, Sun Huili, Liu Hui, and Yuan Xiaobing. The historical editions replaced by this Standard are as follows. --- YY 91095-1999; --- YY/T 1095-2007. Myoelectric Biofeedback Equipment

1 Scope

This Standard specifies the terms and definitions, classification, requirements, test methods of myoelectric biofeedback equipment (hereinafter referred to as the myoelectric biofeedback equipment). This Standard is applicable to the myoelectric biofeedback equipment stipulated in 3.1. This Standard is not applicable to the equipment using needle electrode to record the myoelectric signal, and myoelectric evoked potential equipment.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document. GB 9706.1-2007 Medical Electrical Equipment - Part 1.General Requirements for Safety GB 9706.15-2008 Medical Electrical Equipment - Part 1-1.General Requirements for Safety - Collateral Standard. Safety Requirements for Medical Electrical Systems GB/T 14710-2009 Environmental Requirement and Test Methods for Medical Electrical Equipment GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1.Evaluation and Testing within a Risk Management Process YY 0505-2012 Medical Electrical Equipment - Part 1-2.General Requirements for Safety - Collateral Standards. Electromagnetic Compatibility - Requirements and Tests

3 Terms and Definitions

The following terms and definitions defined in GB 9706.1-2007 are applicable to this document. 3.1 Myoelectric biofeedback equipment The instrument that uses surface electrode to collect the body myoelectric signal as the physiological information, which gives feedback to patients in visual or acoustical forms; 3.2 Surface electrode The electrode that is placed on the skin surface (or cavity surface), and to be used for collecting myoelectric signal to conduct the non-invasive detection. 3.4 Feedback response frequency bands The frequency range that can achieve the expected feedback response. 3.5 Feedback threshold The amplitude when different response degree is achieved.

4 Classification

It can be divided into the myoelectric biofeedback equipment with and without display system as per the structure.

5 Requirements

5.1 Working conditions It shall conform to the manufacturer’s provisions; if there are no provisions, it shall conform to the requirements in Chapter 10 of GB 9706.1-2007. 5.3 Accuracy of feedback threshold The feedback threshold shall be specified by the manufacturer, and shall not be greater than ±10% of the nominal value measured at the center frequency point. 5.5 Display system 5.5.1 Overview The requirements in 5.5.2~5.5.8 are only applicable to the myoelectric biofeedback equipment with display system. The technical indicators in 5.5.2~5.5.8 shall be measured from the output display part of the myoelectric biofeedback equipment. 5.5.6 Differential-mode input impedance Greater than 5MΩ. 5.5.7 Common-mode rejection ratio Greater than 100dB. 5.5.8 Power-frequency notch filter Myoelectric biofeedback equipment shall be equipped with 50Hz notch filter, attenuation-post amplitude shall be no greater than 5µV (Peak-Valley Value). 5.6 Appearance 5.7 Instruction manual The instruction manual shall meet the requirements of GB 9706.1-2007 and GB 9706.15-2008 (if applicable); meanwhile it shall also include at least the following contents. 5.8 Safety requirements The electric safety of myoelectric biofeedback equipment shall meet the requirements of GB 9706.1-2007. If applicable, the electric safety of the system shall meet the requirements of GB 9706.15-2008. 5.9 Environmental test requirements The environmental test of the myoelectric biofeedback equipment shall be performed as per the provisions of GB/T 14710-2009. 5.10 Biocompatibility Materials intended to use in contact with the human skin shall conduct the biocompatibility test or evaluation, and form document according to the guideline and principle stipulated in GB/T 16886.1-2011.

6 Test Methods

6.1 Working conditions 6.1.1 Pre-treatment Before test, the myoelectric biofeedback equipment shall be parked on the test site for at least 24h without being energized; before the official test, the myoelectric biofeedback equipment shall be run as per the requirements of the instruction manual. 6.1.3 Test circuit The connection method of test circuit shall be shown as follows. 6.1.4 Test instrument The test instrument shall meet the following requirements. 6.2 Inspection of feedback indication Connect the electrodes of the myoelectric biofeedback equipment as per the Figure 1; adjust the signal source to generate the test signal stipulated in Table 1; 6.4 Inspection of power-frequency noise suppression Connect the electrodes of the myoelectric biofeedback equipment as per the Figure 1; adjust the signal source to generate the sinusoidal signal output; adjust the signal frequency to reach the center frequency value stipulated by the manufacturer. 6.6 Appearance Inspect through the visual observation, which shall conform to the provision of 5.6. 6.7 Instruction manual Check the instruction manual, which shall conform to the provision of 5.7. 6.8 Safety requirements Safety requirement test shall be performed as per the test methods stipulated in GB 9706.1-2007 and GB 9706.15-2008. 6.9 Environmental test requirements The environmental test of myoelectric biofeedback equipment shall be performed as per the methods and procedures stipulated in GB/T 14710-2009. 6.10 Biocompatibility Compliance is checked through inspecting the materials provided by the manufacturer, or through verification as per the method stipulated in GB/T 16886.1-2011. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

Tips & Frequently Asked Questions

Question 1: How long will the true-PDF of English version of YY/T 1095-2015 be delivered?

Answer: The full copy PDF of English version of YY/T 1095-2015 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.

Question 2: Can I share the purchased PDF of YY/T 1095-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1095-2015_English will be deemed to be sold to your employer/organization who actually paid 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. www.ChineseStandard.us -- YY/T 1095-2015 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.

Question 5: Should I purchase the latest version YY/T 1095-2015?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 1095-2015 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.

How to buy and download a true PDF of English version of YY/T 1095-2015?

A step-by-step guide to download PDF of YY/T 1095-2015_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 1095-2015".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3    Steps 4~6    Step 7    Step 8    Step 9