YY 0950-2015 PDF English
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Extracorporeal pressure wave therapy devices by compressed air
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YY 0950-2015: Extracorporeal pressure wave therapy devices by compressed air---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0950-2015
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.60
C 42
Extracorporeal pressure wave therapy devices by
compressed air
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
3 Terms and definitions
The terms and definitions defined in the GB 9706.1-2007 and the following ones
apply to this document.
3.1 Extracorporeal pressure wave therapy devices by compressed air
The extracorporeal pressure wave therapy devices by compressed air refer to
the therapy devices that use the projectiles in the energy-driven therapy
handles generated by compressed air to conduct impulse-type impact to the
therapy heads, and use the pressure waves generated by the elastic collision
between projectiles and therapy heads to act on the locations of pain by means
of percutaneous conduction.
3.2 Control handle
The operators hold the devices in hands to control the pressure waves
generated by the collision between projectiles and therapy heads driven by
compressed air.
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
5.4 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%.
5.7 Timer or counter
The devices shall have at leave one of the following functions for single therapy
counting.
5.8 Pulse width
The manufacturers shall declare the pulse width of output pressure waves in
the accompanying files. The error shall not be greater than ±10%.
5.10 Overpressure safety unit
5.11 Fatigue performance of therapy heads
The manufacturers shall declare the life cycle of devices (calculated by number
of times) in the accompanying files. Furthermore, the output energy density of
devices throughout the entire cycle shall meet the requirements specified in the
Article 5.4.
5.12 Corrosion resistance
The outer surfaces of therapy heads shall have good corrosion resistance. After
being conducted with the corrosion resistance test, the therapy heads shall
have no corrosion marks, or shall only have slight marks that can be removed
after wiping and simple cleaning.
5.13 Biocompatibility
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
5.16 Safety requirements
The safety requirements of devices shall meet the requirements specified in GB
9706.1-2007.
6 Test methods
6.1 Test devices
The following devices or the test devices whose accuracies are higher than
those of the following devices are recommended to be used during the tests.
6.2 Operating pressure
CONNECT the pressure gauge to the input end of compressed air on the
control handle in series.
6.3 Energy stability
MEASURE the output energy of devices by converting the energy of output
pressure waves into gravitational potential energy. Closely CONNECT the
therapy head with the device shown in Figure 1.The mass block shall be
completely in contact with the probe.
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.
6.13 Biocompatibility
6.13.1 USE the therapy heads made of the proven materials conforming to
the biocompatibility. The manufacturers shall declare the materials of therapy
heads and the material standards used as basis, and provide relevant
evidences as well. The material composition can be verified if necessary.
6.15 Appearance
The verification shall be performed by visual inspection and actual operation.
The results shall meet the requirements specified in the Article 5.15.
6.16 Safety requirements
The test shall be conducted according to the methods specified in the GB
9706.1-2007.
7 Inspection rules
7.1 Inspection category
The quality inspection of devices is divided into exit-factory inspection and type
inspection.
7.2 Exit-factory inspection
The quality inspection department of the manufacturer shall inspect devices
one by one before they leave the factory.
7.2.2 Determination of exit-factory inspection. The exit-factory inspection can
only be determined as qualified after all the inspection items are qualified.
Otherwise, the exit-factory inspection will be determined as unqualified.
7.3 Type inspection
7.3.1 The type inspection shall be conducted in the case of one of the
following conditions.
7.3.2 The samples for type inspection shall be taken from the qualified exit-
factory products. SEE Table 1 for the inspection items.
8 Marks and instructions for use
8.1 Marks
8.1.1 Nameplate
The nameplates shall be installed on the proper locations of devices. The
nameplates shall include the following contents at least.
8.1.2 Outer packaging
8.1.3 Qualification certificate of product inspection
The qualification certificate of product inspection shall include the following
contents at least.
8.1.4 Labels, marks, and the symbols providing information
They shall meet the requirements specified in the YY/T 0466.1-2009.
8.2 Instructions for use
The instructions for use shall include the following contents at least.
9 Packaging, transportation and storage
9.1 Packaging
9.1.3 Solidly FIX the devices in the boxes to prevent the looseness and
scratches during the transportation.
9.1.4 The nude packing of devices shall be performed according to the
provisions specified in the purchase contact. It is necessary to take protective
measures for nude packing during the transportation. The specific requirements
shall conform to the provisions specified in the purchase contact.
9.1.5 The devices shall have the following accompanying files.
9.2 Transportation
The transportation shall conform to the provisions specified in the purchase
contact.
9.3 Storage
The devices shall be stored in the well-ventilated rooms without any corrosive
gases at -40°C~55°C. The relative humidity shall not be greater than 90%.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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