Taiwan Provincial Standard of the People's Republic of China
Latest
CNS 14989-2006
Scope
This standard specifies the manufacturer's procedures for identifying the hazards of medical devices and their accessories, including medical devices for in vitro diagnostics, estimating and evaluating risks, controlling these risks, and monitoring the effectiveness of controls. This standard can be applied to all stages in the life cycle of medical devices, but does not apply to clinical judgment when using medical devices. This standard does not specify acceptable levels of risk, nor does it require manufacturers
CNS 14989-2006 history
2006CNS 14989-2006 Medical devices - Application of risk management to medical devices