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YY/T 0950-2015: Extracorporeal pressure wave therapy devices by compressed air
Status: Valid YY/T 0950: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0950-2015 | English | 269 |
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Extracorporeal pressure wave therapy devices by compressed air
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YY/T 0950-2015
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| YY/T 0950-2015 | English | 269 |
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Extracorporeal pressure wave therapy devices by compressed air
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YY/T 0950-2015
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PDF similar to YY/T 0950-2015
Basic data | Standard ID | YY/T 0950-2015 (YY/T0950-2015) | | Description (Translated English) | Extracorporeal pressure wave therapy devices by compressed air | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 12,130 | | Date of Issue | 2015-03-02 | | Date of Implementation | 2017-01-01 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard is applicable to the equipment that uses the energy generated by compressed air to drive the bullet body in the treatment handle, so that the bullet body pulses the treatment head, and uses the elastic collision of the two to generate pressure waves, which are transmitted percutaneously to the treatment equipment for painful parts. This standard specifies the terms, definitions, components, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage requirements of pneumatic ballistic extracorporeal pressure wave therapy equipment. This standard does not apply to pneumatic ballistic lithotripsy equipment. | YY/T 0950-2015: Extracorporeal pressure wave therapy devices by compressed air---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.
ICS 11:040:60
C42
Pharmaceutical Industry Standard of the People's Republic of China
YY 0950-2015
Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on:2015-03-02
2017-01-01 Implementation
Issued by China Food and Drug Administration
foreword
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
The safety requirements of this standard fully implement the requirements of GB 9706:1-2007 "Medical Electrical Equipment Part 1: General Safety Requirements"
content:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by China Food and Drug Administration:
This standard is under the jurisdiction of the Physical Therapy Equipment Sub-Technical Committee (SAC/TC10/SC4) of the National Medical Electrical Appliances Standardization Technical Committee:
This standard was drafted: State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center:
The main drafters of this standard: Yang Jiangang, Sun Huili, Chen Cheng, Wang Ying:
YY 0950-2015
Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment
1 Scope
This standard specifies the terms and definitions, composition, requirements, and test methods of pneumatic ballistic extracorporeal pressure wave therapy equipment (hereinafter referred to as equipment):
Laws, inspection rules, signs, instructions for use, packaging, transportation and storage:
This standard applies to the equipment specified in 3:1:
This standard does not apply to pneumatic ballistic lithotripsy equipment:
2 Normative references
The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191-2008 Packaging, storage and transportation icon marks
GB 9706:1-2007 Medical Electrical Equipment Part 1: General Safety Requirements
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process
GB/T 16886:5 Biological evaluation of medical devices - Part 5: In vitro cytotoxicity test
GB/T 16886:10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed hypersensitivity
YY/T 0149-2006 Test method for corrosion resistance of medical stainless steel
YY/T 0466:1-2009 Symbols for medical device labeling, marking and providing information for medical devices Part 1: General
Require
3 Terms and Definitions
The following terms and definitions defined in GB 9706:1-2007 apply to this document:
3:1
The energy generated by compressed air is used to drive the bullet body in the treatment handle, so that the bullet body pulses to impact the treatment head, and the elasticity of the two is used:
The impact generates pressure waves, which are transmitted percutaneously to the device for the treatment of painful parts:
3:2
control handle controlhandle
The operator holds the device and controls the compressed air to drive the projectile body to collide with the treatment head to generate pressure waves:
3:3
bullet body projectile
Located in the cavity of the control handle, it is a rigid body that elastically collides with the treatment head under the drive of compressed air:
3:4
energy converterenergytransmitter
treatment head
Located at the end of the control handle, the part that is in contact with the patient: Generally, it is a rigid material, and after elastic collision with the bullet body, the energy is transferred to
YY 0950-2015
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