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YY 0983-2016Therapeutic laser equipment - Ruby laser equipment for therapy (English PDF)

激光治疗设备 红宝石激光治疗机

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 23, 2016

Implementation date

January 1, 2018

Scope

YY 0983-2016 is the English-translated version of 激光治疗设备 红宝石激光治疗机.

YY 0983-2016 is the Chinese standard "Therapeutic laser equipment - Ruby laser equipment for therapy". Its scope clause reads: This standard specifies the composition and basic parameters, requirements, test methods, inspection rules and standards of the ruby (Cr3.

Al2O3) laser treatment machine. Chi, labels, packaging and other requirements. This standard applies to the wavelength of 694.3nm ruby laser treatment machine (hereinafter referred to as treatment machine).

The treatment machine utilizes ruby lasers The principle of selective light and heat, for the surface treatment. Its clauses include normative reference documents; composition with basic parameters.

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Document preview — YY 0983-2016

National Standard of the People's Republic of China

ICS
11.040.60
Classification
C41

Issued by: National Medical Products Administration

Contents

  • Foreword
  • 1 Scope
  • 2 normative reference documents
  • 3 composition with basic parameters
  • 3.1 composition of the treatment machine

1 Scope

This standard specifies the composition and basic parameters, requirements, test methods, inspection rules and standards of the ruby (Cr3. Al2O3) laser treatment machine.

Chi, labels, packaging and other requirements.

This standard applies to the wavelength of 694.3nm ruby laser treatment machine (hereinafter referred to as treatment machine). The treatment machine utilizes ruby lasers

The principle of selective light and heat, for the surface treatment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article

Pieces. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 191 packaging and storage icon

GB 7247.1 Safety of laser products - Part 1. Classification of equipment, requirements

Medical electrical equipment - Part 1. General requirements for safety GB 9706.1

GB 9706.20 Medical electrical equipment - Part 2. Diagnostic and therapeutic requirements for laser equipment safety

Environmental requirements and test methods for medical appliances GB/T GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management

Methods for testing the main parameters of laser goggles GB/T 17736-1999

GB/T 26599.1 Laser and laser related equipment - Test methods for laser beam width, divergence angle and beam transmission ratio - Part 1

Points. no astigmatism and simple astigmatism

General technical conditions for medical foot switch

3 composition with basic parameters

3.1 composition of the treatment machine

The composition of the treatment machine is as follows.

a) ruby lasers;

b) laser power supply;

c) beam transmission system;

d) control and safety protection systems;

e) cooling system;

f) application of accessories (including application of hand tools, etc.);

g) aiming optical device (if any);

h) Other accessories (which may include goggles, foot switches, etc.).

3.2 basic parameters of the treatment machine

The manufacturer shall list the following basic parameters in the registered product standard.

a) treatment of laser wavelength;

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.

Referenced standards

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YY 0983-2016

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