YY/T 0758-2021 English PDF (YYT0758-2021)

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YY/T 0758-2021: General requirements for medical laser fiber
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...