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YY 0844-2011Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument (English PDF)

激光治疗设备 脉冲二氧化碳激光治疗机

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0844-2011 is the English-translated version of 激光治疗设备 脉冲二氧化碳激光治疗机.

YY 0844-2011 is the Chinese pharmaceutical industry standard for the pulsed carbon dioxide laser treatment instrument.

It specifies the basic parameters and the composition of the product, the technical requirements, the test methods, the marking, the labels and the packaging, covering the wavelength and the output power and energy per pulse and their accuracy, the pulse duration and repetition rate, the beam delivery and the aiming beam, the laser classification and the protection of the patient and the operator, and the electrical safety.

It gives the manufacturers of such instruments the technical basis on which a registered product standard is drawn up. Issued on 31 December 2011, it has applied since 1 June 2013.

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Document preview — YY 0844-2011

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword3
  • 1 Scope4
  • 2 Normative references4
  • 3 Terms and definitions5
  • 4 Product composition and basic parameters6
  • 5 Requirements9
  • 6 Test methods14
  • 7 Inspection rules19
  • 8 Marking, label, and instruction manual20
  • 9 Packaging, transportation, and storage22

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".

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

tau50 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.

3.2 Time

Power P peak 50% P 10% P Pulse repetition period (T)

10%-pulse duration tau10 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 is the ratio of pulse energy Q to 50%-pulse duration (50% pulse width) tau50, as shown in equation (1).

3.4 10%-pulse power

P10 is the ratio of pulse energy Q to 10%-pulse duration (10% pulse width) tau10, 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) tau (tau50 and tau10), pulse repetition period T or pulse repetition frequency f or duty cycle eta (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) tau (tau50 and tau10), 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.

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 tau. Pulse duration n.

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

5.2.3 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).

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) tau50 and tau10, pulse repetition period T or pulse repetition frequency f or duty cycle eta.

5.2.1 Laser wavelength

10.6 µm ± 0.1 µm.

5.2.2 Laser mode

Fundamental transverse mode or multimode.

a) Single pulse output mode;

A) If tau50 cannot be adjusted by the operator, the manufacturer shall specify the nominal value of tau50 and its allowable tolerance under the corresponding output mode, or the range of tau50; AND meanwhile give the corresponding nominal value of tau10 and its allowable tolerance, or the range of tau10. 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 tau50 can be adjusted by the operator, the manufacturer shall specify the setting range and its allowable tolerance of tau50 under the corresponding output mode, AND meanwhile provide the corresponding range of tau10 and its tolerance; […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.

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