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YY 0649-2016 English PDF

Q: How long will the true-PDF of English version of YY 0649-2016 be delivered?

Upon your order, we will start to translate YY 0649-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Q: Can I share the purchased PDF of YY 0649-2016_English with my colleagues?

Yes. The purchased PDF of YY 0649-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

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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). Avoidance of Double Taxation Agreements (DTAs) between Singapore and 100+ Countries: https://www.iras.gov.sg/taxes/international-tax

Q: Do you accept my currency other than USD?

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Q: Should I purchase the latest version YY 0649-2016?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0649-2016 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.

US$439.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0649-2016: Electrical potential therapy equipment
Status: Valid

YY 0649: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0649-2016	439	Add to Cart	4 days	Electrical potential therapy equipment	Valid
YY 0649-2008	439	Add to Cart	3 days	High electrical potential therapy equipment	Obsolete

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Basic data

Standard ID: YY 0649-2016 (YY0649-2016)
Description (Translated English): Electrical potential therapy equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 22,247
Date of Issue: 2008-04-25
Date of Implementation: 2018-06-01
Older Standard (superseded by this standard): YY 0649-2008
Quoted Standard: GB/T 191-2008; GB 9706.1-2007; GB 9706.15-2008; GB/T 14710-2009; GB/T 16886.1-2011; YY/T 0466.1-2009; YY/T 0505-2012
Regulation (derived from): State Food and Drug Administration Announcement No. 2016 (No. 129)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the terms and definitions, requirements, test methods, inspection rules, signs, labels, instructions for use, packaging, transport and storage of potential treatment equipment. This standard applies to the potential treatment equipment specified in 3.1 (hereinafter referred to as equipment). This standard also applies to modular devices with potential therapeutic functions. This standard does not apply to the following equipment: electrostatic paste; wearable equipment.

YY 0649-2016: Electrical potential therapy 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.
Electrical potential therapy equipment ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0649-2008 Potential treatment equipment 2016-07-29 released 2018-06-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 requirements 2 5 Test Methods 7 6 Inspection rules 11 7 logo, label, instruction manual 11 8 Packaging, transportation and storage 13 Appendix A (informative) General Guidance 14 Appendix B (normative) Durability test device

Foreword

The technical content of this standard is mandatory. This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0649-2008 "high potential treatment equipment", compared with YY 0649-2008, in addition to editorial modification of the main skills The changes are as follows. - modified terms and definitions. potential treatment equipment, application sections and overcurrent protection devices (see 3.1, 3.2 and 3.9); - Added terms and definitions. treatment mats, treatment blankets and therapeutic mattresses (see 3.3, 3.4 and 3.5); - increase the stability of the output voltage time (see 4.5.2), the safe range of the electric field space (see 4.8), the safe range of the magnetic field 4.9), treatment mats, treatment blankets and treatment mattress durability (see 4.10), working noise (see 4.11), biocompatibility (see 4.12) and Timer (see 4.13.5) requirements; - modified on the output voltage stability (see 4.5.1), output overcurrent protection (see 4.7), function (see 4.13.3), external marking (4.14.2.2), the instruction manual (see 4.14.2.3), the technical specification (see 4.14.2.4), the continuous leakage current and the patient auxiliary current (See 4.14.2.6), abnormal operation and fault conditions (see 4.14.2.10), components and components (see 4.14.2.11) and electromagnetic and Tolerance (see 4.15) requirements; --- Added Appendix B. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Apparatus Standardization Technical Committee of physical therapy equipment standardization sub-technical committee (SAC/TC10/SC4) Go back. The standard drafting unit. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Guanrui Medical Electronics Co., Ltd., Shenzhen City, Elman Medical Electronic Instrument Co., Ltd. The main drafters of this standard. Zhang Haiming, Liu Bo, Gao Shan, Jiang Guoqiang, Jia Yuechao, Zhang Huibing, Qi Liming, Zhang Yun, Qian Xuebo, This standard replaced the previous version of the standard release. --- YY 0649-2008. Potential treatment equipment

1 Scope

This standard specifies the terms and definitions of potential therapy equipment, requirements, test methods, inspection rules and signs, labels, instructions, Packaging, transportation and storage. This standard applies to the potential treatment equipment specified in 3.1 (hereinafter referred to as equipment). Combination therapy with potential therapy function, this standard The same applies. This standard does not apply to the following equipment. --- electrostatic paste; --- wearable equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191-2008 Packaging and storage icon (ISO 780..1997, MOD) GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety (IEC 60601-1-1..2000, IDT) Environmental requirements and test methods for medical appliances GB/T 14710-2009 GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1..2009, IDT) Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1..2007, IDT) YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2004, IDT)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 An apparatus for treating an electric field generated by a voltage having an effective value of not more than 30 kV and a frequency not higher than 100 kHz. Including the use of cross Electric field and DC electric field equipment. 3.2 Apply part of appliedpart Components that are in contact with or in contact with the patient during treatment, including topical treatment head, treatment pad, treatment blanket for systemic treatment, treatment mattress, A chair, a foot pedal, and the like, and an output cable that may be in contact with the patient. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0649-2016_English be delivered?

Answer: Upon your order, we will start to translate YY 0649-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY 0649-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0649-2016_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.

Question 5: Should I purchase the latest version YY 0649-2016?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0649-2016 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.