YY/T 0758-2009 (YY/T0758-2009, YYT 0758-2009, YYT0758-2009)
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General requirements for medical laser fiber
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General requirements for therapeutic laser Fiber
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| Standard ID | YY/T 0758-2009 (YY/T0758-2009) | | Description (Translated English) | General requirements for therapeutic laser Fiber | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040 | | Word Count Estimation | 8,815 | | Date of Issue | 2009-11-15 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB 9706.1; GB 9706.20; GB/T 14233.1; GB/T 14233.2; GB/T 16886.1; YY/T 0313-1998 | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | Optics and optical instruments National Standardization Technical Committee | | Regulation (derived from) | Industry standard filing Notice 2010 No. 2 (No. 122 overall) | | Proposing organization | National Standardization Technical Committee of Medical Optics and optical instruments and equipment Standardization Technical Committee (SAC/TC 103/SC 1) | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard applies to the treatment with a laser fiber (hereinafter referred to as fiber). Refers to an optical fiber as the optical fiber laser transmission medium, through the use of light treatment products. This standard applies to optical fiber does not include examination and diagnostic capabilities with therapeutic fiber. Infrared hollow waveguide is not included. |
YY/T 0758-2009
General requirements for therapeutic laser Fiber
ICS 11.040
C40
People's Republic of China pharmaceutical industry standards
General requirements for treatment with the laser fiber
Posted 2009-11-15
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
This standard by the standardization of medical optical instruments and the National Standardization Technical Committee and optical instruments Technical Committee (SAC /
TC103/SC1) and focal points.
This standard was drafted. State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center.
The main drafters of this standard. Yezhong Chen, Du , Han fortified city, Huangdan.
General requirements for treatment with the laser fiber
1 Scope
This standard specifies the therapeutic laser fiber General requirements.
This standard is applicable to the treatment with the laser fiber (hereinafter referred to as an optical fiber). Fiber refers to an optical fiber laser transmission medium by light
Energy use for treatment products.
This standard applies to optical fiber having a treatment does not include examination and diagnostic functions of optical fiber. Infrared hollow core waveguides are not included.
If the fiber forms part of the device, and can not be removed from the device, the device must comply with the relevant national standards (such as GB 9706.1,
GB 9706.20, GB 7247.1, etc.), and with reference to the implementation of this standard. However, if the optical fiber can be removed from the device, the unit should be removed were
Comply with the requirements of the standard.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1 Medical Electrical Equipment Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988,
IDT)
GB 9706.20 Medical electrical equipment - Part 2. diagnostic and therapeutic laser equipment requirements for the safety (GB 9706.20-2000,
idt IEC 60601-2-22.1995)
GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Biological Evaluation of Medical Devices (GB/T 16886.1-2001, idt
ISO 10993-1.1997)
YY/T 0313-1998 Medical Polymer Co., packaging, labeling, transportation and storage
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Laser optical fiber transmission medium, through product Light energy utilization for treatment.
3.2
Bare Fiber
In the end of the optical fiber transmission body parts pose a direct application.
3.3
Application of body parts and transmission end of the fiber is connected, such as hand-piece, micro controllers, micro lenses and the like.
3.4
Applications components for therapeutic purposes, may be a bare fiber, it can also be external handpiece, a microcontroller, such as Bird.
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