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YY 0792-2024 English PDF (YY 0792.1-2016)
YY 0792-2024. Intraocular illuminators for ophthalmic instruments ICS 11.040.70 CCSC40 Pharmaceutical Industry Standards of the People's Republic of China Replaces YY 0792.1-2016, YY 0792.2-2010 Ophthalmic instruments intraocular illuminator Released on 2024-07-08 2027-07-20 Implementation The State Drug Administration issued Table of Contents Preface III 1 Range 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 2 5 Test methods 4 6 Attached Documents 8 Appendix A (Informative) Method for measuring maximum spectral irradiance in water 9 Appendix B (informative) Example of information provided to users regarding maximum radiation exposure guidance values 10 Preface This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document replaces YY 0792.1-2016 "Ophthalmic instruments intraocular illuminators Part 1.General requirements and test methods" and YY 0792.2-2010 "Ophthalmic instruments intraocular illuminators Part 2.Basic requirements and test methods for optical radiation safety", Compared with YY 0792.2-2010, in addition to structural adjustments and editorial changes, the main technical changes of YY 0792.1-2016 are as follows. --- Deleted the term and definition of "aperture" (see 3.1 of YY 0792.2-2010); --- Deleted the term and definition of "effective aperture" (see 3.1.1 of YY 0792.2-2010); --- Deleted the term and definition of "numerical aperture" (see 3.1.2 of YY 0792.2-2010); --- Added the term and definition of "chandelier-type intraocular illuminator light guide" (see 3.4); --- Deleted the term and definition of "irradiance" (see 3.5 of YY 0792.2-2010); --- Added the term and definition of "tissue hook" (see 3.5); --- Deleted the term and definition of "maximum strength" (see 3.6 of YY 0792.2-2010); --- Added the term and definition of “ordinary (intraocular illuminator light guide)” (see 3.6); --- Deleted the term and definition of "photoretinitis" (see 3.7 of YY 0792.2-2010); --- Added the term and definition of "wide angle (intraocular illuminator light guide)" (see 3.7); --- Deleted the term and definition of "spectral weighted irradiance of photochemical damage to aphakia" (see 3.8 of YY 0792.2-2010); --- Added the terms and definitions of "Class 1 instrument" (see 3.9); --- Added the terms and definitions of "Class 2 instruments" (see 3.10); --- Deleted the "design" requirements (see 4.1 of YY 0792.2-2010); --- Deleted the "limit" requirement (see 4.2 of YY 0792.2-2010); --- Deleted the "visible light" requirement (see 4.3 of YY 0792.2-2010); --- Deleted the "light intensity measuring device" requirement (see 4.4 of YY 0792.2-2010); --- Deleted the "retinal safety filter" requirement (see 4.5 of YY 0792.2-2010); --- Deleted the requirement of “material composition of the part of the light guide inserted into the eye” (see 4.1 of YY 0792.1-2016); --- Deleted the requirement of “biocompatibility of the part of the material of the light guide inserted into the eye” (see 4.2 of YY 0792.1-2016); --- Deleted the requirement of “illumination angle in simulated eye” (see 4.3.1 of YY 0792.1-2016); --- Deleted the requirement of “surface quality of the part inserted into the eye” (see 4.6 of YY 0792.1-2016); --- Deleted the "corrosion resistance (if applicable)" requirement (see 4.11 of YY 0792.1-2016); --- Deleted the "environmental test" requirements (see 4.13 of YY 0792.1-2016); --- Added "output half divergence angle" requirements and test methods (see 4.1.1, 5.1.1); --- Added the requirements and test methods for "optical radiation hazards of intraocular illuminator light sources" (see 4.3, 5.3); --- Added "electromagnetic compatibility" requirements and test methods (see 4.5, 5.5); --- Changed the "central illumination" requirements (see 4.1.2, 4.3.2 of YY 0792.1-2016); --- Changed the "fall impact" requirements (see 4.2.2.4, 4.5.4 of YY 0792.1-2016); --- Changed the "Electrical safety" requirements (see 4.4, 4.12 of YY 0792.1-2016); --- Deleted the test method of “Determination of spectral irradiance” (see Chapter 5 of YY 0792.2-2010); --- Deleted the test method for “material composition of the part of the light guide inserted into the eye” (see 5.1 of YY 0792.1-2016); --- Deleted the test method of "Biocompatibility of materials of the part of the light guide inserted into the eye" (see 5.2 of YY 0792.1-2016); --- Deleted the test method of “illumination angle simulating intraocular conditions” (see 5.3.1 of YY 0792.1-2016); --- Deleted the "Appearance" test method (see 5.6 of YY 0792.1-2016); --- Deleted the "corrosion resistance" test method (see 5.10 of YY 0792.1-2016); --- Deleted the "Environmental test" test method (see 5.12 of YY 0792.1-2016); --- Changed the "Central Illuminance" test method (see 5.1.2, 5.3.2 of YY 0792.1-2016); --- Changed the test method for "overtemperature of the part of the light guide inserted into the eye" (see 5.2.1, 5.4.5 of YY 0792.1-2016); --- Changed the "minimum bending radius" test method (see 5.2.2.3, 5.5.3 of YY 0792.1-2016); --- Changed the "Insulation requirements" test method (see 5.2.4, 5.7 of YY 0792.1-2016); --- Changed the "sterility" test method (see 5.2.5, 5.8 of YY 0792.1-2016); --- Changed the "Electrical safety" test method (see 5.4, 5.11 of YY 0792.1-2016); --- Deleted "marking" (see Chapter 6 of YY 0792.1-2016); --- Deleted "Mark" (see Chapter 7 of YY 0792.2-2010); --- Changed the "Accompanying Documents" (see Chapter 6, Chapter 6 of YY 0792.2-2010); --- Deleted "Retinal safety analysis spectral weighting function" (see Appendix A of YY 0792.2-2010); --- Deleted "Information provided by the manufacturer to the user" (see Appendix B of YY 0792.2-2010). This document is modified to adopt ISO 15752.2010 “Basic requirements and test methods for optical radiation safety of intraocular illuminators for ophthalmic instruments”. This document has the following structural adjustments compared to ISO 15752.2010. ---4.3 corresponds to Chapter 4 of ISO 15752.2010; ---5.1.1 corresponds to 5.2 of ISO 15752.2010; ---5.3.1 corresponds to 5.1 of ISO 15752.2010; ---5.3.2 corresponds to 5.3 of ISO 15752.2010; ---5.3.3 corresponds to 5.4 of ISO 15752.2010; --- Appendix A corresponds to Appendix B of ISO 15752.2010; --- Appendix B corresponds to Appendix A of ISO 15752.2010. The technical differences between this document and ISO 15752.2010 and their reasons are as follows. --- Added "General requirements for intraocular illuminator light sources and intraocular illuminator light guides for intraocular illumination" to the scope (see Section 1 Chapter), in order to adapt to my country's technical conditions; --- The normative reference GB 9706.1-2020 replaces IEC 60601-1 (see 4.4, 5.2.4, 5.4) to adapt to my country's technology condition; --- Added reference document GB/T 5702 (see 5.1.3.3, 5.1.4) to adapt to my country's technical conditions; --- Added reference document GB/T 7922 (see 5.1.3.3) to adapt to my country's technical conditions; --- Added the reference document GB/T 14233.1-2022 (see 5.2.6) to adapt to my country's technical conditions; --- Added reference document YY 9706.102 (see 4.5, 5.5) to adapt to my country's technical conditions; --- Added the reference document "Pharmacopoeia of the People's Republic of China (2020 Edition Volume 4)" (see 5.2.5) to adapt to my country's technology condition; --- Changed the term and definition of "chandelier-type intraocular illuminator light guide" (see 3.4, 3.4 of ISO 15752.2010) to adapt to my country Technical conditions; --- Changed the term and definition of "ordinary (intraocular illuminator light guide)" (see 3.6, 3.6 of ISO 15752.2010) to adapt to my country Technical conditions; --- Changed the term and definition of "wide angle (intraocular illuminator light guide)" (see 3.7, 3.7 of ISO 15752.2010) to adapt to my country Technical conditions; --- Added the requirements for "light source for intraocular illuminator" (see 4.1) to adapt to my country's technical conditions; --- Added the requirements for "light guide for intraocular illuminator" (see 4.2) to adapt to my country's technical conditions; --- Added "electrical safety" requirements and test methods (see 4.4, 5.4) to adapt to my country's technical conditions; --- Added "electromagnetic compatibility" requirements and test methods (see 4.5, 5.5) to adapt to my country's technical conditions; --- Added the test method for "light source for intraocular illuminator" (see 5.1.2 to 5.1.6) to increase operability and facilitate the implementation of the standard; --- Added the test method for "light guide for intraocular illuminator" (see 5.2) to increase operability and facilitate the implementation of the standard; --- Added the test method of "retinal protection measures" (see 5.3.4) to increase operability and facilitate the implementation of the standard; --- Added the test method of "light intensity stability" (see 5.3.5) to increase operability and facilitate the implementation of the standard; --- "Marking" (see Chapter 7 of ISO 15752.2010) has been deleted to adapt to my country's national conditions; --- Change "field of view angle" (see Table A.1 of ISO 15752.2010) to "output half divergence angle" to ensure that the full text is technically consistent. unified. The following editorial changes were also made to this document. --- Changed the standard name. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed and coordinated by the State Food and Drug Administration. The previous versions of this document and the documents it replaces are as follows. ---YY 0792.1, first released in.2016...... YY 0792.1-2016 Ophthalmic instruments - Endoilluminators - Part 1. Requirements and test methods ICS 11.040.70 C40 People's Republic of China Pharmaceutical Industry Standard Ophthalmic instruments intraocular luminaire Part 1. General requirements and test methods Part 1. Requirementsandtestmethods 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued Preface Part 5 of this section is recommended and the remainder is mandatory. YY 0792 "ophthalmic instrument eye illumination device" is divided into two parts. - Part 1. General requirements and test methods; Part 2. Basic requirements and test methods for optical radiation safety. This part is part 1 of YY 0792. This part is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This part of the National Medical Optical Instrument Standardization Subcommittee (SAC/TC103/SC1) proposed and centralized. This part of the drafting unit. the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center, Zhejiang Province, medical equipment inspection Academy. The main drafters of this part. Wang Jingtao, Jia Xiaohang, He Tao, Wen Yan, Yan Qinglai. Ophthalmic instruments intraocular luminaire Part 1. General requirements and test methods 1 Scope This part of YY 0792 specifies the general requirements and test methods for intraocular lasers. The intraocular illuminator is made for ophthalmic surgery Inside lighting. 2 normative reference documents The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Evaluation method of color rendering of light source GB/T 5702-2003 Methods of measurement for the color of illuminated light sources GB/T Medical electrical equipment - Part 1. General requirements for safety GB 9706.1-2007 GB/T 14233.1-2008 Methods of test for medical infusion, transfusion, and injectable utensils - Part 1. Chemical analysis methods GB/T 14233.2-2005 Methods of examination for medical infusion, transfusion, and injectable utensils - Part 2. Biological test methods Environmental requirements and test methods for medical appliances GB/T GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed type hypersensitivity test Test method for corrosion resistance of stainless steel medical instruments YY/T 0149 3 terms and definitions The following terms and definitions apply to this document. 3.1 Intraocular illuminator endoiluminator A device consisting of an intraocular illuminator light source and an intraocular illuminator light guide is intended to be inserted into the eye for intraocular illumination. 3.2 Intraocular illuminator light guide endoiluminatorlightguide Used to transmit light from the light source of the intraocular illuminator and to the instrument in the eye. The intraocular illuminator light is usually synthesized by fiber. 3.3 Intraocular Illuminator Light Source endoiluminatorlightsource A device that generates and directs light into the intraocular illuminator. 4 requirements 4.1 light guide into the eye part of the material composition The light guide is inserted into the material of the eye part, and the manufacturer shall give any expressive form, where the metallic material shall be marked with a grade and/or ...... Similar standards: YY 0792.1-2016 YY/T 0787-2024 Similar PDFs (Auto-delivered in 9 seconds): YY 0762-2017 YY/T 0758-2021 YY/T 0842-2011 YY 0843-2011 |