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YY/T 0128-2023: Protective devices against diagnostic medical X-radiation - Device and tool Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0128: Historical versions
Similar standardsYY/T 0128-2023: Protective devices against diagnostic medical X-radiation - Device and tool---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0128-2023YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.50 CCS C 43 YY/T 0128-2023 Replacing YY/T 0128-2004 Protective Devices against Diagnostic Medical X-radiation - Device and Tool Issued on. MARCH 14, 2023 Implemented on. MAY 1, 2024 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 5 2 Normative References... 5 3 Terms and Definitions... 6 4 Requirements... 7 5 Inspection Methods... 13 Appendix A (normative) Some Commonly Used Protective Devices and Basic Requirements... 18 Appendix B (informative) General Guidelines and Preparation Instructions... 23 Bibliography... 271 ScopeThis document specifies the requirements and inspection methods for the protective devices and tools against diagnostic medical X-radiation (hereinafter referred to as protective devices). This document is applicable to protective devices provided to users to shield or attenuate medical diagnostic X-ray radiation. This document does not apply to wearable medical diagnostic X-ray radiation protective supplies.2 Normative ReferencesThe contents of the following documents constitute indispensable clauses of this document through normative references in the text. In terms of references with a specified date, only versions with a specified date are applicable to this document. In terms of references without a specified date, the latest version (including all the modifications) is applicable to this document. GB 9706.1-2020 Medical Electrical Equipment - Part 1.General Requirements for Basic Safety and Essential Performance GB 9706.103 Medical Electrical Equipment - Part 1-3.General Requirements for Basic Safety and Essential Performance - Collateral Standard. Radiation Protection in Diagnostic X-ray Equipment GB 9706.243 Medical Electrical Equipment - Part 2-43.Particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Interventional Procedures YY/T 0292.1-2020 Protective Devices against Diagnostic Medical X-radiation - Part 1. Determination of Attenuation Properties of Materials YY 9706.102 Medical Electrical Equipment - Part 1-2.General Requirements for Basic Safety and Essential Performance - Collateral Standard. Electromagnetic Compatibility - Requirements and Tests IEC/TR 60788 Medical Electrical Equipment - Glossary of Defined Terms3 Terms and DefinitionsThe terms and definitions defined in GB 9706.1-2020, GB 9706.103, GB 9706.243, YY/T 0292.1-2020 and IEC/TR 60788, and the following are applicable to this document. 3.1 x-ray attenuation material A uniformly distributed material mainly composed of one or more elements with an atomic number higher than 47. 3.2 lead attenuation material A uniformly distributed material mainly composed of lead element, and does not contain other elements with an atomic number higher than 47. 3.6 effective shielding area The area formed by the X-ray attenuation material with a lead equivalent value reaching a specified lead equivalent class. 3.7 protective shield A constituent unit of the protective device that is made of hard X-ray attenuation material and provides protection to the users. 3.8 protective curtain A constituent unit in protective device made of an inner layer of soft X-ray attenuation material and an outer layer of waterproof knitted fabric or other waterproof soft materials, which provides protection to the users. 3.12 table mounted type A description of the functional characteristic of a protective device capable of being fixed at the bedside where a fluoroscopy-guided interventional operation equipment performs by its own connector.4 Requirements4.1 Materials and Composition The key materials and main components constituting the protective device. 4.2 Structure and Basic Mechanical Functions The structure and basic mechanical functions of the protective device. 4.3 Protective Performance Indicators 4.3.1 Lead equivalent class The lead equivalent of the protective device shall be no less than its lead equivalent class. The lead equivalent class of the protective device. 4.4 Mobility and Stability of Movement 4.4.1 Mobile protective device When the mobile protective device moves under the condition of normal use, the external force required to move the mobile protective device on a hard and flat horizontal surface shall not be greater than 200 N, unless the instruction manual states that multiple people are required to push it. 4.5 Visible Light Transmittance At the light wavelength of 550 nm, the transmittance of the transparent part of the protective shield required for visual observation shall not be less than 80%. 4.6 Safety 4.6.1 Protection against mechanical hazards for passive protective devices 4.6.1.4 Protection against splash hazard For mobile or suspended protective devices, if the protective shield or part of the protective shield uses lead glass with an area greater than or equal to 0.24 m2, then, the lead glass shall be pasted with anti-splash film on both sides or use laminated lead glass. 4.6.2 Safety requirements for active protective devices 4.7 Appearance5 Inspection Methods5.1 Materials and Composition Conduct visual inspection of the protective device and check the bill of materials, which shall comply with the stipulations of 4.1. 5.2 Structure and Basic Mechanical Functions Conduct the inspection through visual inspection and / or by means of the following gauges or methods. 5.3 Protective Performance Indicators 5.3.1 Lead equivalent class 5.3.1.2 Test method Adopt the X-ray radiation beams that comply with the radiation mass specified in 5.3.1.1, under the configuration of wide beam conditions specified in 4.3 or the reverse wide beam conditions specified in 4.4 of YY/T 0292.1-2020, carry out the test. The lead equivalent class of the protective device shall comply with the stipulations of 4.3.1. 5.4 Mobility and Stability 5.5 Visible Light Transmittance From the transparent X-ray attenuation material or product of the same batch to be measured, cut a test sample. Use a spectrophotometer and light with a wavelength of 550 nm to conduct the measurement, which shall comply with the stipulations of 4.5. 5.6 Safety 5.6.1 Protection against mechanical hazards for passive protective devices 5.6.1.2 Protection against fall hazard 5.6.1.4 Protection against splash hazard Through visual observation, inspect the lead glass or check the bill of materials of the lead glass, and determine the protection against splash hazard, which shall comply with the stipulations of 4.6.1.4. 5.6.2 Active protective device 5.6.2.1 In accordance with the method specified in the relevant stipulations of GB 9706.1-2020, conduct the determination, which shall comply with the stipulations of 4.6.2.1. 5.6.2.2 In accordance with the method specified in the relevant stipulations of YY 9706.102, conduct the determination, which shall comply with the stipulations of 4.6.2.2. 5.7 Appearance Conduct the inspection through visual inspection, which shall comply with the stipulations of 4.7.1, 4.7.2 and 4.7.3. 5.8 Specification Markings Check the specification markings in the instructions and labels, which shall comply with the stipulations of 4.8. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
