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YY 0792-2024: Ophthalmic instruments - Endoilluminators
Status: Valid YY 0792: Evolution and historical versions
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| YY 0792-2024 | English | 369 |
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Ophthalmic instruments - Endoilluminators
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YY 0792-2024
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| YY 0792.1-2016 | English | 199 |
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Ophthalmic instruments - Endoilluminators - Part 1: Requirements and test methods
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YY 0792.1-2016
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PDF similar to YY 0792-2024
Basic data | Standard ID | YY 0792-2024 (YY0792-2024) | | Description (Translated English) | Ophthalmic instruments - Endoilluminators | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 18,118 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0792.1-2016, YY 0792.2-2010 | | Issuing agency(ies) | State Drug Administration | YY 0792-2024: Ophthalmic instruments - Endoilluminators---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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 Scope 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
Foreword
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 as YY 0792.1-2016;
---YY 0792.2, first issued in.2010 as YY 0792.2-2010;
---This is the first revision.
Ophthalmic instruments intraocular illuminator
1 Scope
This document specifies the general requirements, radiation quality, and performance of intraocular illuminator light sources and intraocular illuminator light guides for intraocular illumination during ophthalmic surgery.
Radiation safety requirements and describes the corresponding test methods.
This document applies to intraocular illuminator light sources and intraocular illuminator light guides for intraocular illumination during ophthalmic surgery.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 5702 Evaluation method for color rendering of light sources
GB/T 7922 Measurement method of lighting source color
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and essential performance (IEC 60601-1.
2012,MOD)
GB/T 14233.1-2022 Inspection methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods
YY 9706.102 Medical electrical equipment Part 1-2.General requirements for basic safety and essential performance Collateral standard. Electromagnetic compatibility
Capacity requirements and tests (YY 9706.102-2021, IEC 60601-1-2.2007, MOD)
Pharmacopoeia of the People's Republic of China (2020 Edition, Part IV)
ISO 15004-2.2007 Ophthalmic instruments Basic requirements and test methods Part 2.Protection against light hazards (Ophthalmicinstru-
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Light exit aperture
The portion of an intraocular illuminator light guide through which light from the intraocular illuminator light source is output.
3.2
Endoiluminator
A device consisting of an intraocular illuminator light source and a fiber-optic intraocular illuminator light guide, intended for insertion into the eye to illuminate any part of the eye
part.
3.3
A device that transmits light from an intraocular illuminator light source into the eye.
3.4
Chandelier type intraocular illuminator light guide chandelier
Intraocular illuminator light guides intended for placement near the sclera typically have an output half-divergence angle ≥ 30° in air.
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