YY/T 0758-2021 PDF in English

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YY/T0758-2021 (YYT0758-2021): PDF in English

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 .......
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