What is PD IEC/TR 80001-2-2 - Disclosure and communication of medical devices about?
PD IEC/TR 80001 is a European that discusses risk management for IT networks incorporating medical devices. PD IEC/TR 80001-2-2 provides a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT networks and for the security dialogue that surrounds the IEC 80001-1 risk management of IT-network connection to minimise hazardous situations.
PD IEC/TR 80001-2-2 presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered, and the risks that lead to the controls. Intended use and local factors determine which exact capabilities are useful in the dialogue about risk.
Note 1: PD IEC/TR 80001-2-2 does not contain sufficient detail for the exact specification of requirements in a request for proposal or product security disclosure sheet.
Note 2: The classification and structure can be used to organize such requirements with underlying detail sufficient for communication during the purchase and integration PROCESS for a MEDICAL DEVICE or IT equipment component.
Note 3: PD I...