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YY 0904-2013 English PDF

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YY 0904-2013: Battery power supply surgical equipment for osseous tissue
Status: Obsolete
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY 0904-2013399 Add to Cart 3 days Battery power supply surgical equipment for osseous tissue Obsolete

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Basic data

Standard ID: YY 0904-2013 (YY0904-2013)
Description (Translated English): Battery power supply surgical equipment for osseous tissue
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 9,985
Quoted Standard: GB/T 191; GB 9706.1-2007; GB/T 14710; GB/T 16886.1; YY 0174; YY 0505; YY/T 1052-2004; YY 1137-2005
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the battery-powered bone tissue surgical equipment (hereinafter referred to as device) terms and definitions, classification and composition requirements, test methods, inspection rules, signs, instructions, packaging, transport an

YY 0904-2013: Battery power supply surgical equipment for osseous tissue

---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.
Battery power supply surgical equipment for osseous tissue ICS 11.040.60 C42 People's Republic of China pharmaceutical industry standards Battery-powered bone tissue surgical equipment Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. If the requested material or structure in the form of equipment or components used in connection with the standards required by different, but if they can prove that it reaches the same Requirements, which should be recognized. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard by the National Technical Committee of Standardization for medical electrical physical therapy equipment at the Technical Committee (SAC/TC10/SC4) centralized. This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Fang Jun, Chen Cheng, mountain road. Battery-powered bone tissue surgical equipment

1 Scope

This standard specifies the battery-powered bone tissue surgical equipment (hereinafter referred to as the device) terms and definitions, classification and composition requirements, test side Method, inspection rules, signs, instructions, packaging, transport and storage. This standard applies to battery-powered surgical device for bone tissue. This standard does not apply to bone tissue surgical equipment pneumatic devices. This standard does not apply to the power supply network of bone tissue surgical equipment. This standard does not apply to similar devices in dentistry.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 191 Packaging - Pictorial signs GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety GB/T 14710 medical electrical environmental requirements and test methods GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test YY 0174 scalpel blade YY 0505 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests YY/T 1052-2004 mark surgical instruments YY 1137-2005 bone saw General technical conditions

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Powered by a battery, to provide mechanical power to implement bone tissue surgical medical devices. 3.2 Phone handpiece Gripped by the operator, and can hold and control the operation of the tool to achieve the purpose of the operation member, for example, various types of drill class, Saw, cone Class, grinding (filing) class, knives phone. 3.3 Tool cutter Holding on the phone, expected means for the implementation of bone tissue surgery.

4 Classification and composition

4.1 Classification Equipment for internal power supply.
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