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YY 0950-2015 English PDF (YY0950-2015)

YY 0950-2015 English PDF (YY0950-2015)

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YY 0950-2015: Extracorporeal pressure wave therapy devices by compressed air

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.
YY 0950-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.60
C 42
Extracorporeal pressure wave therapy devices by
compressed air
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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...

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