YY 0633-2008 (English Version) PDF

Scope: This standard specifies the basic requirements and test methods for hand-lensed and head-mounted indirect ophthalmoscopes. This standard does not apply to condensers and their accessories for indirect ophthalmoscopy. This standard does not apply to food products that are fixed on the table, such as Gullstrand ophthalmoscopes and such derivative foods, nor to ophthalmoscopes that capture and/or process images, such as those that use laser scanning technology.

YY 0633-2008 Referenced Document

CIE 13.3-1995 Method of Measuring and Specifying Colour Rendering Properties of Light Sources (E)
GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
GB/T 5702-2003 Methods of measuring the color of light sources
ISO 15004:1997 Ophthalmic instruments - Fundamental requirements and test methods