YY 1475-2016Laser therapeutic equipment - Q-switched Nd: YAG laser equipment (English PDF)
激光治疗设备 Q开关掺钕钇铝石榴石激光治疗机
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
January 26, 2016
Implementation date
January 1, 2018
Scope
YY 1475-2016 is the English-translated version of 激光治疗设备 Q开关掺钕钇铝石榴石激光治疗机.
YY 1475 is the mandatory Chinese standard for Q-switched Nd:YAG laser therapy equipment, the nanosecond-pulse lasers used to remove tattoos and pigmented lesions by shattering pigment particles faster than the surrounding tissue can heat.
The extremely short pulse is the therapeutic mechanism and the hazard: peak power is enormous, and a stray pulse to the retina causes immediate permanent damage.
The standard sets the requirements such equipment has to meet and the test methods that verify them, covering the output energy and pulse duration and their accuracy, the beam delivery, the interlocks and the eye protection.
These devices are sold in very large numbers into Chinese aesthetic clinics. Being a YY standard without the /T suffix, compliance is compulsory in China.
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Document preview — YY 1475-2016
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C41
Issued by: National Medical Products Administration
Contents
- ForewordIII
- 1 Scope1
- 2 Normative reference document1
- 3 Product composition and basic parameters1
- 4 Requirements2
- 5 Test Method5
- 6 Inspection rules8
- 7 Logo, label, instruction manual8
- 8 Packaging, transportation, storage9
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is nationalized by the National Standardization Subcommittee for Medical Optics and Instruments (SAC/TC103/SC1).
The drafting of this standard unit. Zhejiang Medical Device Testing Institute.
The main drafters of this standard. Ye Yue Shun, Du Kun, He Tao, Yu Zhenhua.
Laser treatment equipment Q switch doped neodymium yttrium aluminum garnet
Laser treatment machine
1 Scope
This standard specifies the basic parameters and product composition, technical requirements and test methods of Q-switched neodymium-yttrium aluminum garnet laser treatment machine.
And logo labels, packaging and other requirements.
This standard applies to the wavelength of 1064nm or frequency 532nm Q switch (using Q-switched technology) doped neodymium yttrium aluminum garnet laser treatment
Treatment machine (hereinafter referred to as treatment machine). The treatment machine uses laser and biological tissue selective absorption mechanism, micro-blasting to achieve treatment purpose.
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 document. 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 condition of YY 1057 medical foot switch
3 product composition and basic parameters
Remaining clauses in the full document
- 2 Normative reference document
- 3 Product composition and basic parameters
- 4 Requirements
- 5 Test Method
- 6 Inspection rules
- 7 Logo, label, instruction manual
- 8 Packaging, transportation, storage
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 7247.1Safety of laser products - Part 1: Equipment classification and requirements
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- GB/T 26599.1Lasers and laser-related equipment -- Test methods for laser beam widths, divergence angles and beam propagation ratios -- Part 1: Stigmatic and simple astigmatic beam
- YY 1057General specifications for medical foot switches
GB 9706.20 · GB/T 17736-1999
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Related Standards
GB 7247.1-2012 — Safety of laser products - Part 1: Equipment classification and requirements
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.103-2020 — Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance. Collateral Standard: Radiation protection in diagnostic X-ray equipment
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YY 1475-2016
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