YY/T 0758-2021 (YY/T0758-2021, YYT 0758-2021, YYT0758-2021) & related versions
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YY/T 0758-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.404
C 40
Replacing YY/T 0758-2009
General Requirements for Medical Laser Fiber
ISSUED ON: SEPTEMBER 06, 2021
IMPLEMENTED ON: SEPTEMBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Structural Composition and Classification ... 6
5 Requirements ... 7
6 Test Methods ... 11
7 Packaging, Marking, Instructions, Transportation and Storage ... 18
General Requirements for Medical Laser Fiber
1 Scope
This Standard specifies general requirements for medical laser optical fibers.
This Standard applies to medical laser optical fibers (hereinafter referred to as optical fibers)
that transmit laser light.
This Standard does not apply to optical fibers with gain function.
If the optical fiber forms part of the equipment and cannot be removed from the equipment, the
equipment must comply with the relevant national standards (such as GB 9706.1, GB 9706.20,
GB 7247.1, etc.), and refer to the implementation of this Standard. However, if the optical fiber
can be removed from the equipment, the removed unit shall comply with the applicable
requirements of 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) is applicable to this
document.
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety
and Essential Performance
GB 9706.19 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety
of Endoscopic Equipment
GB/T 14233.1-2008 Test Methods for Infusion Transfusion Injection Equipment for
Medical Use - Part 1: Chemical Analysis Methods
GB/T 16886.1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
Within a Risk Management Process
YY/T 0313 Medical Polymer Products - Requirement for Package and Information
Supplied by Manufacturer
YY 9706.102 Medical Electrical Equipment - Part 1-2: General Requirements for Basic
Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -
Requirements and Tests
ISO 11146 (all parts) Lasers and Laser-Related Equipment – Test Methods for Laser Beam
Widths, Divergence Angles and Beam Propagation Ratios
China Pharmacopeia 2020
3 Terms and Definitions
For the purposes of this Document, the following terms and definitions apply.
3.1 Medical laser fiber
A product that uses optical fiber as the propagation medium to transmit laser energy.
3.2 Fiber applicator
The applied parts that are directly formed by the end of the optical fiber cable.
3.3 Additional applicator
Applied parts that are connected to the end of the optical fiber cable.
NOTE: Such as handpieces, microcontrollers, etc.
3.5 Optical fiber cable
The part of an optical fiber that is used to transmit laser light; it is generally composed of a core,
a cladding, and a coating.
NOTE: The coating layer includes buffer layer and protective layer.
3.5 Connector
A component that connects an optical fiber to a laser device.
3.6 Tensile strength
The maximum tensile force that the material can withstand.
4 Structural Composition and Classification
4.1 Structural composition
Medical laser fiber is mainly composed of connector, fiber transmission body, application end
and protective cap.
4.2 Product classification
The manufacturer shall give the nominal value and tolerance of the core diameter (or diameter
of fiber bundle), and the tolerance shall not exceed ±10%. If the fiber core diameter (or diameter
of fiber bundle) at the input end and the output end of the fiber are inconsistent, the nominal
value and tolerance shall be given respectively, and the tolerance should not exceed ±10%.
5.3 Optical properties
5.3.1 Maximum transmission power (or energy) of optical fiber
The manufacturer shall give the nominal value of the maximum transmission power (or energy)
of the optical fiber during the specified working time when the optical fiber transmits the
specified wavelength; and the measured value shall be no less than the nominal value.
5.3.2 Divergence angle
If the fiber applicator of the optical fiber is a flush-cut optical fiber, the manufacturer shall
provide the nominal value (or range) and tolerance of the output divergence angle of the optical
fiber terminal, and the tolerance shall not exceed ±20%.
5.3.3 Optical fiber transmission efficiency
5.3.3.1 When the optical fiber is placed straight, the transmission efficiency of the
corresponding wavelength shall be no less than the value specified by the manufacturer.
5.3.3.2 The transmission efficiency of the reusable optical fiber can still reach the
manufacturer's specified value after the insertion and removal test.
5.3.4 Disinfection and sterilization
Disposable non-sterile optical fibers and reusable optical fibers are subjected to a disinfection
and sterilization test according to the method specified in the instructions. After the test, the
optical fiber transmission efficiency can still reach the manufacturer's specified value.
5.4 Mechanical properties
5.4.1 Tensile strength of optical fiber
The tensile strength of the joint between the optical fiber cable and the connector, and the joint
between the optical fiber cable and the applicator shall be no less than the specified value of
the manufacturer. After the tensile test, the optical fiber shall be intact without damage.
5.4.2 Minimum bending working radius of optical fiber
If the optical fiber is allowed to be bent, the manufacturer shall specify the minimum bending
working radius. After being bent to this value, the transmission efficiency of the optical fiber
shall be no less than 90% of that when it is placed straight.
5.4.3 Bending fatigue resistance of optical fiber
Unless otherwise specified, the fiber shall be capable of being repeatedly bent for 100 times at
the minimum bending working radius of the optical fiber provided by the manufacturer. After
the bending fatigue resistance test, the optical fiber transmission efficiency can still reach the
manufacturer's specified value.
5.5 Requirements for non-flush-cut optical fiber
5.5.1 Cylinder optical fiber
5.5.1.1 The manufacturer shall give the luminous length, outer diameter and tolerance of the
cylinder, and the tolerance shall not exceed ±20%.
5.5.1.2 The manufacturer shall give the maximum bending angle of the light-emitting cylinder
and the cable. After the bending test, there is no crack between the light-emitting cylinder and
the cable, and the maximum transmission power shall meet the requirements of 5.3.1.
5.5.1.3 The uniformity of the power density distribution of the cylindrical optical fiber shall be
no greater than ±20%.
5.5.1.4 The manufacturer shall give the proportion of light emitted from the end face.
5.5.2 Spherical (or hemispherical) optical fiber
5.5.2.1 The manufacturer shall give the outer diameter and tolerance of the spherical (or
hemispherical) end, and the tolerance shall not exceed ±20%.
5.5.2.2 If the output is focused after passing through a spherical (or hemispherical) optical fiber,
the manufacturer shall provide the focal spot size, focal length and tolerance, and the tolerance
shall not exceed ±20%.
5.5.2.3 If the output is uniform after passing through a spherical (or hemispherical) optical fiber,
the uniformity of the spot power density distribution shall be no greater than ±20%.
5.5.3 Microlens optical fiber
5.5.3.1 The manufacturer shall give the outer diameter and tolerance of the microlens optical
fiber, and the tolerance shall not exceed ±20%.
5.5.3.2 The uniformity of the light spot power density distribution shall be no greater than ±20%.
5.5.4 Oblique-firing optical fiber
5.5.4.1 The manufacturer shall give the angle and tolerance of the oblique beam and the optical
fiber cable, and the tolerance shall not exceed ±20%.
5.5.4.2 The manufacturer shall give the terminal output divergence angle (or the spot size at the
working distance) and the tolerance, and the tolerance shall not exceed ±20%.
5.6 Requirements for additional applicator
5.6.1 Optical needle
5.6.1.1 The manufacturer shall give the length, outer diameter and tolerance of the optical
needle, and the tolerance shall not exceed ±20%.
5.6.1.2 If the optical needle can be bent, the bending angle and tolerance shall be given, and the
tolerance shall not exceed ±20%.
5.6.1.3 The manufacturer shall give the nominal value and tolerance of the terminal output
divergence angle, and the tolerance shall not exceed ±20%.
5.6.2 Hand tool
5.6.2.1 The manufacturer shall give the diameter and tolerance of the hand tool, and the
tolerance shall not exceed ±20%.
5.6.2.2 The manufacturer shall give the transmission efficiency of the hand tools used to
connect the optical fibers.
5.6.2.3 Carry out the disinfection and sterilization test of the additional hand tool according to
the method specified in the instructions. After the test, the transmission efficiency of the
additional hand tool can still reach the manufacturer's specified value.
5.7 Appearance
The surface of the optical fiber shall be smooth and free of sharp edges, burrs and cracks. The
parts are connected compactly and are not easy to peel off.
5.8 Sterility
The optical fibers that are packaged in sterile packaging shall be sterile.
5.9 Residual amount of ethylene epoxide
If the optical fiber is sterilized with ethylene epoxide, the residual amount of ethylene epoxide
in the optical fiber shall be no greater than 0.1 mg/piece.
5.10 Biocompatibility
Parts of equipment components and accessories that are expected to come into contact with
biological tissues, cells or body fluids shall be evaluated and certified in accordance with the
guidelines and principles given in GB/T 16886.1.
5.11 Safety performance
5.11.1 Electrical safety shall meet the requirements of GB 9706.1.
results shall meet the requirements of 5.4.1.
6.4.2 Minimum bending working radius of optical fiber
According to the minimum bending working radius specified by the manufacturer, bend the
optical fiber; and test the transmission efficiency according to the method specified in 6.3.3,
and the result shall meet the requirements of 5.4.2.
6.4.3 Bending fatigue resistance of optical fiber
After the optical fiber cable is repeatedly bent 100 times under the working conditions of the
minimum bending radius specified by the manufacturer, the transmission efficiency shall be
tested according to the method specified in 6.3.3; and the result shall meet the requirements of
5.4.3.
6.5 Requirements for non-flush-cut optical fiber
6.5.1 Cylindrical optical fiber
6.5.1.1 Use a general measuring tool to measure the luminous length and outer diameter of the
cylindrical optical fiber; and the results shall meet the requirements of 5.5.1.1.
6.5.1.2 Bend according to the maximum bending angle of the cylindrical optical fiber and cable
given by the manufacturer, and repeat 10 times. After the test, there shall be no break between
the cylinder and the cable; and the maximum transmission power shall be tested according to
the method specified in 6.3.1; and the result shall meet the requirements of 5.5.1.2.
6.5.1.3 Place a power meter at the working distance, and place an iris (aperture of iris ≤ 2.5mm)
in front of the power meter. Carry out the power density test according to the test points marked
in Figure 3; and obtain the power density value Pi (i= 1, 2, 3, …, 12); find the maximum value
Pmax and the minimum value Pmin in Pi; and calculate the uniformity G of the light spot power
density distribution according to Formula (3); and the result shall meet the requirements of
5.5.1.3.
requirements of 5.6.1.3.
6.6.2 Hand tools
6.6.2.1 Use a general measuring tool to measure the diameter of the hand tool; and the result
shall meet the requirements of 5.6.2.1.
6.6.2.2 Set the maximum transmission power (or energy) that can be transmitted by the optical
fiber and the hand tool specified by the manufacturer; emit laser light; and use a laser power
meter (or energy meter) to test the output power (or energy) when the optical fiber
fails/succeeds to connect to the hand tool, respectively. The transmission efficiency of the hand
tool is obtained through the test value after connecting the hand tool divided by the test value
before connecting the hand tool; and the result shall meet the requirements of 5.6.2.2.
6.6.2.3 Disinfect and sterilize the additional hand tool according to the method specified in the
instructions. The number of disinfections and sterilizations shall be according to the number of
repeatedly-used times. After disinfection and sterilization, carry out the transmission efficiency
test of the additional hand tool again according to the test method in 6.6.2.2; and the results
shall meet the requirements of 5.6.2.3. If multiple disinfection and sterilization methods are
specified in the instructions, all methods shall be verified.
6.7 Appearance
Take visual inspection and hand feeling; and inspect with a microscope, if necessary, which
shall comply with the provisions of 5.7.
6.8 Sterility
The test shall be carried out according to the 1101 Sterility Inspection Method in the Four
General Rules of the China Pharmacopeia 2020; and the results should meet the requirements
of 5.8.
6.9 Residual amount of ethylene epoxide
Carry out the test according to the method in Clause 9 of GB/T 14233.1-2008; and the results
should meet the requirements of 5.9.
6.10 Biocompatibility
Test according to the method specified in GB/T 16886.1, which shall meet the requirements of
5.10.
6.11 Safety properties
6.11.1 According to the requirements of GB 9706.1, the test shall meet the requirements of
5.11.1.
6.11.2 According to the requirements of GB 9706.19, the test shall meet the requirements of
......
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.
......
| Standard ID | YY/T 0758-2021 (YY/T0758-2021) | | Description (Translated English) | General requirements for medical laser fiber | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040 | | Word Count Estimation | 14,156 | | Date of Issue | 2021-09-06 | | Date of Implementation | 2022-09-01 | | Summary | This standard specifies general requirements for medical laser fibers. This standard applies to medical laser optical fibers (hereinafter referred to as optical fibers) that transmit laser light. This standard does not apply to optical fibers with gain function. If the optical fiber forms a part of the equipment and cannot be removed from the equipment, the equipment must comply with the relevant national standards (such as GB9706.1, GB9706.20, GB7247.1, etc.), and refer to the implementation of this standard. However, if the fibre can be removed from the equipment, the removed unit shall comply with the applicable requirements of this standard. | | 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. |
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