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YY 0001-2008   Technical requirements of equipment for extracorporeally induced lithotripsy (English Version)
Standard No.: YY 0001-2008 Status:valid remind me the status change

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Language:English File Format:PDF
Word Count: 4000 words Price(USD):100.0 remind me the price change

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Implemented on:2009-12-1 Delivery: via email in 1 business day
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Standard No.: YY 0001-2008
English Name: Technical requirements of equipment for extracorporeally induced lithotripsy
Chinese Name: 体外引发碎石设备技术要求
Chinese Classification: C39    Medical electronic equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by: China Food and Drug Administration
Issued on: 2008-04-25
Implemented on: 2009-12-1
Status: valid
Superseding:YY 0001-1990 Technical requirements of equipment for extracorporeally induced lithotripsy
Language: English
File Format: PDF
Word Count: 4000 words
Price(USD): 100.0
Delivery: via email in 1 business day
1 Scope This standard specifies terms and definitions, product classification, technical requirements, test methods, inspection rules, marking and other requirements of the equipment for extracorporeally induced lithotripsy (hereinafter referred to as equipment according to the definition in 3.1). This standard is applicable to the equipment with electrohydraulic, electromagnetic and piezoelectric pressure pulse generator as lithotripsy wave source, which are mainly used for crushing the urinary stone. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. 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: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy (IEC 60601-2-36: 1997, MOD) GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61323-3-1: 1999, IDT) GB 10152-1997 B Mode Ultrasonic Diagnostic Equipment YY/T 0291-2007 The Environmental Requirements and Test Methods for Medical Electrical Equipment GB/191-2008 Packaging-Pictorial Marking for Handling of Goods GB/T 13384-1992 General Specifications for Packaging of Mechanical and Electrical Product 3 Terms and Definitions For the purpose of this standard, the following terms and definitions apply. 3.1 Equipment for extracorporeally induced lithotripsy It refers to the equipment that conducts treatment by inducing pressure pulse extracorporeally. 3.2 Electrohydraulic lithotriptor It refers to the equipment that generates pressure pulse by high voltage discharge in the liquid. 3.3 Electromagnetic lithotriptor It refers to the equipment which generates pressure pulse by means of electromagnetic field variation in coils to cause metal film vibration. 3.4 Piezoelectric lithotriptor It refers to the equipment which makes multiple piezoelectric chip to produce a small-energy pressure pulse respectively and then gathers at the focus point to crush stone by means of converse piezoelectric effect. 3.5 Lithotriptor with water cushion It refers to the lithotriptor equipment which is adopted with water cushion without direct contact between human body and water. 3.6 Medical ultrasonic localization device It refers to the equipment which is adopted with medical ultrasonic imaging technique for observing and determining the intracorporal stone state and position. 3.7 Medical X-ray localization device It refers to the equipment which is adopted with medical X-ray perspective imaging technique for observing and determining the intracorporal stone state and position. 3.8 Pressure pulse It refers to the sound wave emitted from the equipment. 3.9 Focus of pressure pulse It refers to the point with maximum compressed sound pressure after the pressure pulse is focused 3.10 Focal volume It refers to the space volume comprised of the surface defined by the -6 dB isobaric line of compressed sound pressure peak. 3.11
1 Scope 2 Normative References 3 Terms and Definitions 4 Product Classification 5 Technical Requirements 6 Test Methods 7 Inspection Rules 8 Marking, Packaging, Transportation and Storage Appendix A (Informative) Examples for Test Devices of X-ray Image Resolution
Referred in YY 0001-2008:
*GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
*GB 9706.22-2003 Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
*GB/T 19042.1-2003 Evaluation and routine testing in medical imaging departments--Part 3-1:Acceptance test-Imaging performance of X-ray equipment for radiographic and radioscopic systems
*GB 10152-1997 B mode ultrasonic diagnostic equipment
*YY/T 0291-2007 Environmental requirements and test methods for medical x-ray equipment
*-
*GB/T 13384-1992 General specification for packagings of mechanical and electrical products
Code of China
Standard
YY 0001-2008  Technical requirements of equipment for extracorporeally induced lithotripsy (English Version)
Standard No.YY 0001-2008
Statusvalid
LanguageEnglish
File FormatPDF
Word Count4000 words
Price(USD)100.0
Implemented on2009-12-1
Deliveryvia email in 1 business day
Detail of YY 0001-2008
Standard No.
YY 0001-2008
English Name
Technical requirements of equipment for extracorporeally induced lithotripsy
Chinese Name
体外引发碎石设备技术要求
Chinese Classification
C39
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2008-04-25
Implemented on
2009-12-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
YY 0001-1990 Technical requirements of equipment for extracorporeally induced lithotripsy
Language
English
File Format
PDF
Word Count
4000 words
Price(USD)
100.0
Keywords
YY 0001-2008, YY/T 0001-2008, YYT 0001-2008, YY0001-2008, YY 0001, YY0001, YY/T0001-2008, YY/T 0001, YY/T0001, YYT0001-2008, YYT 0001, YYT0001
Introduction of YY 0001-2008
1 Scope This standard specifies terms and definitions, product classification, technical requirements, test methods, inspection rules, marking and other requirements of the equipment for extracorporeally induced lithotripsy (hereinafter referred to as equipment according to the definition in 3.1). This standard is applicable to the equipment with electrohydraulic, electromagnetic and piezoelectric pressure pulse generator as lithotripsy wave source, which are mainly used for crushing the urinary stone. 2 Normative References The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies. 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: Particular Requirements for the Safety of Equipment for Extracorporeally Induced Lithotripsy (IEC 60601-2-36: 1997, MOD) GB/T 19042.1-2003 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-1: Acceptance Test - Imaging Performance of X-ray Equipment for Radiographic and Radioscopic Systems (IEC 61323-3-1: 1999, IDT) GB 10152-1997 B Mode Ultrasonic Diagnostic Equipment YY/T 0291-2007 The Environmental Requirements and Test Methods for Medical Electrical Equipment GB/191-2008 Packaging-Pictorial Marking for Handling of Goods GB/T 13384-1992 General Specifications for Packaging of Mechanical and Electrical Product 3 Terms and Definitions For the purpose of this standard, the following terms and definitions apply. 3.1 Equipment for extracorporeally induced lithotripsy It refers to the equipment that conducts treatment by inducing pressure pulse extracorporeally. 3.2 Electrohydraulic lithotriptor It refers to the equipment that generates pressure pulse by high voltage discharge in the liquid. 3.3 Electromagnetic lithotriptor It refers to the equipment which generates pressure pulse by means of electromagnetic field variation in coils to cause metal film vibration. 3.4 Piezoelectric lithotriptor It refers to the equipment which makes multiple piezoelectric chip to produce a small-energy pressure pulse respectively and then gathers at the focus point to crush stone by means of converse piezoelectric effect. 3.5 Lithotriptor with water cushion It refers to the lithotriptor equipment which is adopted with water cushion without direct contact between human body and water. 3.6 Medical ultrasonic localization device It refers to the equipment which is adopted with medical ultrasonic imaging technique for observing and determining the intracorporal stone state and position. 3.7 Medical X-ray localization device It refers to the equipment which is adopted with medical X-ray perspective imaging technique for observing and determining the intracorporal stone state and position. 3.8 Pressure pulse It refers to the sound wave emitted from the equipment. 3.9 Focus of pressure pulse It refers to the point with maximum compressed sound pressure after the pressure pulse is focused 3.10 Focal volume It refers to the space volume comprised of the surface defined by the -6 dB isobaric line of compressed sound pressure peak. 3.11
Contents of YY 0001-2008
1 Scope 2 Normative References 3 Terms and Definitions 4 Product Classification 5 Technical Requirements 6 Test Methods 7 Inspection Rules 8 Marking, Packaging, Transportation and Storage Appendix A (Informative) Examples for Test Devices of X-ray Image Resolution
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