YY 0904-2013Battery power supply surgical equipment for osseous tissue (English PDF)
电池供电骨组织手术设备
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY 0904-2013 is the English-translated version of 电池供电骨组织手术设备.
YY 0904-2013 is the Chinese pharmaceutical industry standard for battery powered surgical equipment for bone tissue, the cordless handpieces that drill, saw and ream bone.
It specifies the terms and definitions, the classification and composition, the requirements, the test methods, the inspection rules, the signs, the instructions and the rules for packaging, transport and storage, covering the speed and the torque delivered and their accuracy, the battery and its capacity, the coupling of the tool, the heat and the noise produced, the cleaning and sterilization and the electrical safety. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY 0904-2013
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C 42
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Classification and composition
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.
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 Battery power supply surgical equipment for osseous tissue
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY 0174Scalpel blade
- YY 0505Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
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Related Standards
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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