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YY 0001: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| YY 0001-2008 | English | 439 |
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Technical requirements of equipment for extracorporeally induced lithotripsy
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| YY 0001-1990 | English | 759 |
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General technical requirements for extracorporeal shock wave lithotripter
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Basic data
| Standard ID | YY 0001-2008 (YY0001-2008) |
| Description (Translated English) | Technical requirements of equipment for extracorporeally induced lithotripsy |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard |
| Classification of Chinese Standard | C39 |
| Classification of International Standard | 11.040.01 |
| Word Count Estimation | 11,197 |
| Date of Issue | 2008-04-25 |
| Date of Implementation | 2009-12-01 |
| Older Standard (superseded by this standard) | YY 0001-1990 |
| Quoted Standard | GB 9706.1-2007; GB 9706.22-2003; GB/T 19042.1-2003; GB 10152-1997; GB/T 14710-1993; GB/T 191-2008; GB/T 13384-1992 |
| Regulation (derived from) | SFDA [2008] No. 192 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the in vitro induced lithotripsy equipment (by 3. 1 definition, hereinafter referred to as the device) the terms and definitions, product classification, technical requirements, test methods, inspection rules and signs and other requirements. This standard applies to hydro-electric, electromagnetic, piezoelectric pressure pulse generator of gravel wave source equipment, crushing equipment, mainly used for urinary calculi. |
YY 0001-2008: Technical requirements of equipment for extracorporeally induced lithotripsy
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Technical requirements of equipment for extracorporeally induced lithotripsy
ICS 11.040.01
C39
People's Republic of China pharmaceutical industry standards
Replacing YY 0001-1990
In vitro initiation Crushing Equipment Technical Requirements
Posted 2008-04-25
2009-12-01 implementation
State Food and Drug Administration issued
Foreword
This standard replaces YY 0001-1990 "extracorporeal shock wave lithotripsy machine general technical conditions."
This standard YY 0001-1990 major differences are.
--- Standard name modification;
--- Safety requirements for the modification according to GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" execution;
--- Environmental testing requirements modified to press GB/T 14710-1993 "Medical electrical equipment environmental requirements and test methods" execution;
--- Updated the outdated reference standard;
--- Remove 3.1 terminology;
--- Increasing the number of terms;
--- Remove the technical requirements for the non-technical content 5.1;
--- 5.4.1 and 5.4.4 of the index change is given by the manufacturer;
--- 5.4.11 change the recommended;
--- Remove the technical requirements of 5.4.12,5.4.14,5.6.1,5.6.3,5.6.4,5.6.5;
--- Deleted 8.3.
Appendix A of this standard is an informative annex.
This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. Shanghai Medical Device detection.
The main drafters of this standard. and Yu.
This standard replaces the standards previously issued as follows.
--- YY 0001-1990.
In vitro initiation Crushing Equipment Technical Requirements
1 Scope
This standard specifies the initiation in vitro lithotripsy device (3.1 by definition, hereinafter referred to as the device) terms and definitions, product classifications, technical to
Requirements, test methods, inspection rules and signs and other requirements.
This standard applies to liquid electrical, electromagnetic, piezoelectric pressure pulse generator gravel wave source device, the device is mainly used for crushing bleeding
Urinary tract stones.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)
GB 9706.22-2003 Medical electrical equipment - Part 2. In vitro initiation of equipment for safety (IEC 60601-2-
36.1997, MOD)
Evaluation of GB/T 19042.1-2003 medical imaging departments and routine testing - Part 3-1. X-ray photography and fluoroscopy systems
X-ray imaging equipment performance acceptance test (IEC 61223-3-1.1999, IDT)
GB 10152-1997 B-type ultrasonic diagnostic equipment
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
GB/T 191-2008 Packaging - Pictorial signs
GB/T 13384-1992 mechanical and electrical products packaging General technical conditions
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Pressure pulse therapy device in vitro by initiation.
3.2
In the high-voltage discharge liquid pressure pulse device.
3.3
The coil in the electromagnetic field caused by changes in metal membrane vibration generated pressure pulse device.
3.4
By the inverse piezoelectric effect, so that each of the plurality of piezoelectric wafer to produce a small pressure pulse energy, and to gravel devices converging at the focal point.
3.5
Body not in direct contact with water, using bladders coupled crushing equipment.
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