This standard specifies the minimum requirements and test methods for synopsis machines (which can be called large amblyopia correction lenses or synoptoscopes). Synopsis machines are used to examine, measure, train and correct patients' binocular vision as well as measure lateral, longitudinal and rotational deviations at different gaze positions. If this standard differs from other related standards, this standard takes precedence.
YY 0675-2008 Referenced Document
GB 9706.1-2007 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