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YY 0950-2015 English PDF (YY/T 0950-2015)

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YY 0950-2015English170 Add to Cart 0--9 seconds. Auto-delivery Extracorporeal pressure wave therapy devices by compressed air Obsolete YY 0950-2015
YY/T 0950-2015English269 Add to Cart 3 days [Need to translate] Extracorporeal pressure wave therapy devices by compressed air Valid YY/T 0950-2015


BASIC DATA
Standard ID YY 0950-2015 (YY0950-2015)
Description (Translated English) Extracorporeal pressure wave therapy devices by compressed air
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 11,123
Date of Issue 2015-03-02
Date of Implementation 2017-01-01
Quoted Standard GB/T 191-2008; GB 9706.1-2007; GB/T 14710-2009; GB/T 16886.1; GB/T 16886.5; GB/T 16886.10; YY/T 0149-2006; YY/T 0466.1-2009
Drafting Organization State Food and Drug Administration, Tianjin Medical Device Quality Supervision and Inspection Center
Administrative Organization National Technical Committee of Standardization for medical electrical physical therapy equipment Standardization Technical Committee
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard specifies the terms and definitions pneumatic ballistic pressure wave therapy equipment in vitro, composition, requirements, test methods, inspection rules, signs, instructions, packaging, transport and storage. 3.1 This Standard applies to equipment regulations. This Standard does not apply to pneumatic ballistic lithotripsy equipment.

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 12,138
Date of Issue 2015-03-02
Date of Implementation 2017-01-01
Drafting Organization State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center
Administrative Organization National Medical Electrical Appliance Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee (SAC/TC 10/SC 4)
Proposing organization China Food and Drug Administration
Issuing agency(ies) China 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 0950-2015 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.60 C 42 Extracorporeal pressure wave therapy devices by compressed air 气压弹道式体外压力波治疗设备 ISSUED ON. MARCH 2, 2015 IMPLEMENTED ON. JANUARY 1, 2017 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 5  4 Composition ... 6  5 Requirements ... 6  6 Test methods ... 9  7 Inspection rules ... 15  8 Marks and instructions for use ... 16  9 Packaging, transportation and storage ... 17  Foreword This Standard was drafted in accordance with the provisions given in the GB/T 1.1-2009. The safety requirements of this Standard have fully implemented the contents of GB 9706.1-2007 Medical electrical equipment – Part 1. General requirements for safety. Please pay attention that some contents in this document might involve patents. The issuing authority of this document does not undertake the responsibility for the identification of these patents. This Standard was proposed by China Food and Drug Administration. This Standard shall be under the jurisdiction of the Technical Sub-committee of Physical Therapeutic Devices of the National Technical Committee for Standardization of Medical Electrical Equipment (SAC/TC 10/SC 4). Drafting organization of this Standard. Tianjin Medical Devices Quality Surveillance and Test Center of China Food and Drug Administration. Main drafters of this Standard. Yang Jiangang, Sun Huili, Chen Cheng, and Wang Ying. Extracorporeal pressure wave therapy devices by compressed air 1 Scope This Standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marks, instructions for use, packaging, transportation and storage of the extracorporeal pressure wave therapy devices by compressed air (hereinafter referred to as equipment). This Standard applies to the equipment specified in the Article 3.1. This Standard does not apply to the rock crushing equipment by compressed air. 2 Normative references The following documents are essential to the application of this document. For dated references, only the versions with the dates indicated are applicable to this document. For undated references, only the latest versions (including all the amendments) are applicable to this document. GB/T 191-2008 Packaging – Pictorial marking for handling of goods GB 9706.1-2007 Medical electrical equipment – Part 1. General requirements for safety GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 16886.1 Biological evaluation of medical devices – Part 1. Evaluation and testing within a risk management process GB/T 16886.5 Biological evaluation of medical devices – Part 5. Test for in vitro cytotoxicity GB/T 16886.10 Biological evaluation of medical devices – Part 10. Tests for irritation and delayed-type hypersensitivity YY/T 0149-2006 Medical instruments of stainless steel – Test methods of corrosion resistance 4 Composition The devices generally include host machines, control handles (containing projectiles), therapy heads, and air compressors (generally included in the host computers). 5 Requirements 5.1 Operating conditions The operating conditions shall conform to the provisions formulated by manufacturers. If not specified, the operating conditions shall meet the requirements specified in the Chapter 10 of GB 9706.1-2007. 5.2 Operating pressure 5.2.1 The manufacturers shall declare the maximum operating pressure of devices in the accompanying files. The maximum operating pressure shall not be greater than 600kPa. 5.2.2 The devices shall be equipped with operating pressure display units. The error between display value and actual value shall not exceed ±10%. 5.2.3 The maximum output pressure of air compressors shall not be greater than 1.5 times the maximum operating pressure declared by manufacturers. 5.3 Energy stability The energy stability of the pressure waves generated by devices shall be better than ±20%. 5.4 Energy density The manufacturers shall declare the maximum energy density of each therapy head in the accompanying files. The error shall not be greater than ±20%. 5.5 Depth of penetration The manufacturers shall declare the maximum depth of penetration of devices in the accompanying files. The error shall not be greater than ±20%. 5.6 Collision frequency The collision frequency of projectiles and therapy heads shall be adjustable. The error of the collision frequency shall not exceed ±10%. after wiping and simple cleaning. 5.13 Biocompatibility 5.13.1 Materials The therapy heads in contact with human bodies shall be made of the proven materials conforming to the biocompatibility. Otherwise, they shall pass the biocompatibility test specified in the Article 5.13.2. 5.13.2 Biocompatibility test 5.13.2.1 Cytotoxicity test. The cytotoxic reaction shall not be greater than Level 1. 5.13.2.2 Skin irritation test. The average score of the skin irritation reaction shall be within the range of 0 to 0.4. The reaction shall be classified as very slight reaction. 5.13.2.3 Sensitization test. There shall be no delayed-type hypersensitivity. 5.14 Functions 5.14.1 The devices shall have the function of displaying, setting or adjusting the operating pressure, collision frequency, time of therapy, or number of collisions. 5.14.2 The devices shall have the function of prompting the insufficient air pressure. 5.14.3 Besides the counting function required in the Article 5.7, each device shall also have a separate counter (or counting function) to record the total number of collisions of projectiles and therapy heads. Furthermore, the above- mentioned counters can only be reset by manufacturers. 5.15 Appearance The appearance of devices shall be clean and without any mechanical damages, scratches or other defects. The marks shall be clear and distinct. The operating and regulating mechanisms shall be flexible and reliable. The fasteners shall be tight. The display screens shall be clear without any luminance non-uniformity or other defects. The plug connectors of tubing sets shall be tightly connected without any looseness. The surfaces of therapy heads shall be smooth, bright and clean. 5.16 Safety requirements intermediate points. USE an oscilloscope to measure the electromagnetic valve for air pressure control. The results shall meet the requirements specified in the Article 5.6. 6.7 Timer and counter For the devices with timing function, USE a stopwatch to measure the maximum set value of the timer or for 30min. TAKE whichever is less. The timing error shall meet the requirements specified in the Article 5.7. For the devices with counting function, USE a stopwatch to measure for 15min or the maximum operating time when the device is configured at maximum collision frequency. TAKE whichever is less. USE the results and measuring time given in the Article 6.6 to calculate the count value. The results shall meet the requirements specified in the Article 5.7. 6.8 Pulse width The duration of pulse width refers to the corresponding time interval value at 50% of the pulse peak read from the pressure waves displaying on the oscilloscope during the test described in the Article 6.5. The results shall meet the requirements specified in the Article 5.8. 6.9 Pressure-resistant performance of tubing sets CONDUCT independent test to the connecting tubing sets. CONDUCT test to the tubing sets according to the pressure source described in the Article 6.1 c). The results shall meet the requirements specified in the Article 5.9. 6.10 Overpressure safety unit This unit can ensure the device operation under normal operating condition where might generate maximum pressure, and can also simulate the single fault condition that might occur. OBSERVE the operating condition of the overpressure safety unit. The results shall meet the requirements specified in the Article 5.10. 6.11 Fatigue performance of therapy heads The actual operation of devices shall be conducted according to the service life declared by manufacturers. After conducting impact test to projectiles and therapy heads according to the specified number of times, the measurement shall be conducted according to the test methods specified in the Article 6.4. The results shall meet the requirements specified in the Article 5.11. 6.12 Corrosion resistance The test shall be conducted according to the methods specified in the YY/T factory products. SEE Table 1 for the inspection items. 7.3.3 Determination of type inspection. The type inspection can only be determined as qualified after all the inspection items are qualified. Otherwise, the type inspection will be determined as unqualified. 8 Marks and instructions for use 8.1 Marks 8.1.1 Nameplate The nameplates sha... ......


YY/T 0950-2015: Pneumatic Ballistic Extracorporeal Pressure Wave Therapy Equipment 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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