YY 0950-2015_English: PDF (YY0950-2015)
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Extracorporeal pressure wave therapy devices by compressed air
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YY 0950-2015
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Standards related to: YY 0950-2015
| 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. | 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...
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