YY 0844-2011 (YY0844-2011) & related versions
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Laser therapeutic equipment. Pulsed carbon dioxide laser treating instrument
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YY 0844-2011
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PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.60
C 41
Laser therapeutic equipment –
Pulsed carbon dioxide laser treating instrument
激光治疗设备
ISSUED ON. DECEMBER 31, 2011
IMPLEMENTED ON. JUNE 01, 2013
Issued by. China Drug and Food Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Product composition and basic parameters ... 6
5 Requirements ... 9
6 Test methods ... 14
7 Inspection rules ... 19
8 Marking, label, and instruction manual ... 20
9 Packaging, transportation, and storage ... 22
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1.2009.
This standard implements GB 9706.1-2007 “Medical electrical equipment - Part
1. General requirements for safety”, GB 9706.20-2000 “Medical electrical
equipment - Part 2. Particular requirements for the safety of diagnostic and
therapeutic laser equipment”, AND GB 7247.1-2001 “Safety of laser products -
Part 1. Equipment classification, requirements and user guide”.
Please note that some of the contents of this document may be related to
patents. The issuer of this document is not responsible for identifying such
patents.
This standard was proposed by China Food and Drug Administration.
This standard shall be under the jurisdiction of the National Medical Optics and
Instruments Standardization Technical Committee (SAC/TC 103/ SC 1).
This standard was drafted by China Food and Drug Administration Hangzhou
Medical Device Quality Supervision and Inspection Center, Zhejiang Medical
Device Testing Institute, and Chongqing Jingyu Laser Technology Co., Ltd.
The main drafters of this standard. Han Jiancheng, Zhou Zhikang, Du Kun, Ye
Yueshun, Kong Peng.
Laser therapeutic equipment –
Pulsed carbon dioxide laser treating instrument
1 Scope
This standard specifies the basic parameters and product composition,
technical requirements, test methods, Marking labels and packaging of pulsed
carbon dioxide laser treatment instrument. This standard provides technical
specifications for manufacturers of pulsed carbon dioxide laser treatment
instrument to develop medical device registered product standards.
This standard is applicable to the pulsed operation section of the pulsed carbon
dioxide laser treatment instrument containing only a pulsed operation mode
AND the pulsed carbon dioxide laser treatment instrument containing both the
continuous wave operation mode and pulsed operation mode (hereinafter,
simply referred to as the treatment instrument) of a carbon dioxide laser
therapeutic apparatus including both a. The term “pulse” in this standard has
the pulse duration (pulse width) less than 0.25 s. The treatment instrument is,
via the pulse laser of wavelength 10.6 μm, conducting vaporization,
carbonization, coagulation and irradiation against the human tissue, in order to
achieve the purpose of treatment.
As for the pulsed carbon dioxide laser treatment instrument containing both the
continuous wave operation mode and pulsed operation mode, the continuous
wave operation mode shall comply with GB 11748, AND the pulsed operation
mode shall comply with this standard.
2 Normative references
The following documents are essential to the application of this document. For
the dated documents, only the versions with the dates indicated are applicable
to this document; for the undated documents, only the latest version (including
all the amendments) are applicable to this Standard.
GB/T 191 Packaging - Pictorial marking for handling of goods
GB 7247.1 Safety of laser products - Part 1. Equipment classification,
requirements and user guide
GB 9706.1 Medical electrical equipment - Part 1. General requirements for
safety
GB 9706.20 Medical electrical equipment - Part 2. Particular requirements
for the safety of diagnostic and therapeutic laser equipment
GB/T 14710 Environmental requirements and test methods for medical
electrical equipment
GB/T 17736 Testing method of main parameters for laser protective eyewear
YY 91057 General specification for medical foot switch
ISO 11146 Lasers and laser-related equipment test methods for laser beam
widths, divergence angles and beam propagation ratios
3 Terms and definitions
The terms and definitions as defined in GB 7247.1 AND the following apply to
this document.
3.1
50%-pulse duration
τ50
It refers to the time interval between the rise and fall of the laser pulse to its
50% peak power point, as shown in Figure 1.
Figure 1 Schematic diagram of laser pulse duration (pulse width) and
pulse repetition period
3.2
Time
Power
P peak
50% P
10% P
Pulse repetition period (T)
10%-pulse duration
τ10
It refers to the time interval between the rise and fall of the laser pulse to its
10% peak power point, as shown in Figure 1.
3.3
50%-pulse power
P50
P50 is the ratio of pulse energy Q to 50%-pulse duration (50% pulse width)
τ50, as shown in equation (1).
3.4
10%-pulse power
P10
P10 is the ratio of pulse energy Q to 10%-pulse duration (10% pulse width)
τ10, as shown in equation (2).
4 Product composition and basic parameters
4.1 Composition of treatment instrument
a) Carbon dioxide laser;
b) Power and control systems;
c) Safety protection system;
d) Targeting and transmission systems;
e) Cooling systems;
f) Output systems and accessories (which may include output hand tools,
scanning devices/dot matrix output devices, etc.).
4.2 Basic parameters of treatment instrument
a) Wavelength and mode of treatment laser;
b) Treatment laser terminal output pulse energy Q, pulse train energy Qtrain,
average power Pav, pulse power P50 and P10;
c) Treatment laser pulse duration (pulse width) τ (τ50 and τ10), pulse repetition
period T or pulse repetition frequency f or duty cycle η (SEE Figure 1 and
2);
d) Treatment laser pulse train duration (pulse train width) T1, pulse train time
interval T2 (SEE Figure 2) or pulse train repetition period Ttrain; in-train
pulse number n, in-train pulse duration (pulse width) τ (τ50 and τ10), the in-
train pulse repetition period T (SEE Figure 1 and 2);
e) Treatment laser terminal output divergence angle, focal (light) spot
diameter;
f) Targeting light wavelength;
g) Targeting light power.
4.3 Safety category
The manufacturer shall list the following safety categories in the registered
product standards.
a) Class and type in accordance with the provisions of GB 9706.1;
b) Category of laser radiation in accordance with GB 7247.1.
Figure 2 Schematics of laser pulse output mode and time parameters
Single pulse output mode
Power P/W
Ppeak
Power P/W
Ppeak
Power P/W
Pmean
Ppeak
Pmean
Power P/W
Ppeak
Pmean
Repeated pulse output mode
T. pulse repetition period
T. pulse duration
Time/s
Time/s
Pulse train single output mode
Pulse train repeated output mode
Foot switch pressed
Time/s
Time/s
T1. Pulse train duration
T. Pulse repetition period
τ. Pulse duration
n. in-train pulse number
T2. Pulse train time interval
Ttrain
5 Requirements
5.1 Normal operating conditions
The manufacturer shall specify at least the following parameters for normal
operating conditions.
- Ambient temperature;
- Relative humidity;
- Power supply used.
5.2 Treatment laser
5.2.1 Laser wavelength
10.6 μm ± 0.1 μm.
5.2.2 Laser mode
Fundamental transverse mode or multimode.
5.2.3 Laser pulse output mode and its time characteristics (SEE Figure 1
and Figure 2)
5.2.3.1 The manufacturer shall specify the laser pulse output mode, which may
include (SEE Figure 2).
a) Single pulse output mode;
b) Pulse repetition output mode;
c) Pulse train single output mode;
d) Pulse train repetition output mode.
5.2.3.2 Laser pulse duration (pulse width) τ50 and τ10, pulse repetition period T
or pulse repetition frequency f or duty cycle η.
A) If τ50 cannot be adjusted by the operator, the manufacturer shall specify
the nominal value of τ50 and its allowable tolerance under the
corresponding output mode, or the range of τ50; AND meanwhile give the
corresponding nominal value of τ10 and its allowable tolerance, or the
range of τ10. If T cannot be adjusted by the operator, the manufacturer
shall specify the nominal value of T and its allowable tolerance under the
corresponding output mode, or the range of T; AND the above allowable
tolerances shall not exceed ± 20%.
Note. allowable tolerance refers to the allowable deviation of the measured value of the
actual output from its nominal value or set value (deviation refers to the algebraic
difference of the measured value of the actual output minus its nominal value or set
value), same as below.
B) If τ50 can be adjusted by the operator, the manufacturer shall specify the
setting range and its allowable tolerance of τ50 under the corresponding
output mode, AND meanwhile provide the corresponding range of τ10 and
its tolerance; if T or f or η can be adjuste...
......
| Standard ID | YY 0844-2011 (YY0844-2011) | | Description (Translated English) | Laser therapeutic equipment. Pulsed carbon dioxide laser treating instrument | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C41 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 15,180 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 191; GB 7247.1; GB 9706.1; GB 9706.20; GB/T 14710; GB/T 17736; YY 91057; ISO 11146 | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the pulsed carbon dioxide laser treatment of the basic parameters and product composition, technical requirements, test methods, and signs labeling, packaging, etc., this standard pulsed carbon dioxide laser treatment for the manufacturer of medical devices registered product standards developed to provide technical specifications. This standard applies only to contain the pulse operation mode and pulsed carbon dioxide laser treatment machine containing both continuous wave operation mode, pulsed operation mode carbon dioxide laser treatment of pulsed operation section. This standard refers to "pulse", the pulse duration (pulse width) is less than 0. 25s. Treatment machine via a wavelength of 10. 6��m pulsed laser on human tissue vaporization, carbonization, freezing and irradiation, to achieve the purpose of treatment. |
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