This standard specifies the definition, classification, requirements, test methods, inspection rules, signs, labels, instructions and packaging, transportation and storage of keratometers. This standard applies to keratometers. The keratometer is used to measure the radius of curvature of the spherical and toric front surface of the cornea and the central area of the contact lens.
YY 0579-2005 Referenced Document
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 191-2000 Packaging-Pictorial marking for handling of goods