YY/T 0863-2011Medical endoscopes - Endoscope functional supply units - Roller irrigation and suction equipment (English PDF)
医用内窥镜 内窥镜功能供给装置 滚压式冲洗吸引器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0863-2011 is the English-translated version of 医用内窥镜 内窥镜功能供给装置 滚压式冲洗吸引器.
YY/T 0863-2011 is the Chinese pharmaceutical industry standard for the roller irrigation and suction equipment used as a functional supply unit with a medical endoscope in minimally invasive surgery, to irrigate the field and aspirate the fluid.
It sets the requirements for such equipment, covering the flow and the pressure delivered and their control, the suction and the collection of the fluid, the roller pump and the tubing it takes, the alarms and the electrical safety. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 0863-2011
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
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 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard provides for the medical endoscope Roller wash aspirator (hereinafter referred to as flushing sucker) requirements.
This standard applies to endoscopic surgery Roller wash used in the attractor. The products are used in minimally invasive endoscopic surgery and rinse attract.
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 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.19-2000 electrical equipment - Part 2. Safety of endoscopic equipment
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
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
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Functional endoscopic supply means
In the minimally invasive endoscopic diagnostic and (or) treatment/surgery, providing apparatus or equipment support functions.
4 Requirements
4.1 Structural requirements
Rinse aspirator should be configured to have both flushing and compelling features.
4.2 Pressure limit
4.2.1 Preset pressure adjustment range limit
If the flushing attract the preset pressure limit is adjustable, the manufacturer shall give the preset limit pressure adjustment range, and should be flush with the sucker preset The actual pressure limit adjustment range consistent.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.19-2000Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- 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
- GB/T 16886.5-2003Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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Related Standards
GB 9706.19-2000 — Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
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YY/T 0863-2011
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