YY 0579-2016Ophthalmic instruments—Ophthalmometers (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0579-2005 "corneal curvature meter". The main technical differences between this standard and YY 0579-2005 are as follows.

--- delete the classification (2005 edition of Chapter 4);

- Removed the requirements for light exposure (2005 Edition 5.4) and the test method (2005 edition 6.5);

- Removed the appearance requirements (2005 edition 5.5) and the test method (2005 edition 6.5);

- Removed the positioning adjustment requirements (2005 edition 5.6) and the test method (2005 version 6.6);

- Removal of biocompatibility requirements (2005 edition 5.7) and test methods (2005 edition 6.8);

- Removed environmental requirements (2005 edition 5.9) and test methods (2005 edition 6.10);

- the inspection rules were deleted (Chapter 7 of 2005);

--- Removal of inspection certificate mark requirements (2005 version 8.1.2);

--- Removal of packaging, transportation and storage requirements (2005 edition 9).

This standard adopts the re-drafting method to modify ISO 10343.:2009 "ophthalmic instrument corneal curvature meter".

There are technical differences between this standard and ISO 10343.:2009, and the terms involved in these differences have been passed through the margin in its outer margin The vertical single line (|) is marked. The technical differences between this and ISO 10343.:2009 and the reasons are as follows.

--- on the normative reference documents, this standard has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. Replace IEC 60601-1 with GB 9706.1.

- Measure the deviation from Table 1 in ISO 10343.:2009, type 1 from "± 0.015mm" to "± 0.03mm", type 2 "± 0.05mm" to "± 0.06mm".

The data processing method of 5.2.2 and 5.3.2 in Chapter 5 of the test method has been added. The test method is operable.

1 Scope

This standard, together with ISO 15004-1.:2006, specifies the requirements and test methods for continuous or numerical indication of corneal curvature. Some horns Membrane curvature (type 1 in Table 1) is able to measure the radius of curvature of the corneal contact lens, assuming that the corneal anterior surface and the contact lens surface are balls Face or ring surface.

If there are differences, this standard takes precedence over ISO 15004-1.:2006.

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 document. For undated references, the latest edition (including all amendments) applies to this document.

GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT)

ISO 15004-1.:2006 Basic requirements and test methods for ophthalmic instruments - Part 1. General requirements for all ophthalmic instruments (Ophthalmicinstruments-Fundamentalrequirementsandtestmethods-Part 1. Generalrequirementsappli-cabletoalophthalmicinstruments

ISO 8429 Optics and Optical Instruments Ophthalmology-Ophthalmology- Graduateddialscale)

3 Terms and definitions

The following terms and definitions apply to this document.