This standard provides a quality reference model for medical service software products, stipulates the testing content of medical service software products, and quality evaluation criteria. This standard is applicable to: a) The demander determines the medical service software quality requirements and product confirmation criteria based on this; b) The supplier determines the quality assurance criteria based on this and the requirements put forward by the demander; c) The evaluator determines the quality assurance criteria based on this and relevant national standards and User requirements, build test environment, design test cases, execute tests and product evaluation.