GOST R 59769-2021 - Std. & Spec

Scope: This standard establishes approaches to planning the risk analysis and assessment process when implementing the risk management process for medical devices and is applied in conjunction with the requirements of GOST ISO 14971. The requirements of this standard are applicable to all stages of the life cycle of medical devices at the planning stage of the risk analysis and assessment process. The standard is intended to assist manufacturers and other users in the practical implementation of the requirements of GOST ISO 14971 in the field of: 　——understanding the requirements for the planning process of risk analysis and assessment (hereinafter referred to as risk assessment); 　——understanding the objectives and scope of plans, their possible types and contents; 　——development of policies in the field of risk assessment; 　——development of criteria for assessing risk acceptability; 　——application of feedback in planning; 　——creating and maintaining documented information on planning the risk assessment process

GOST R 59769-2021 history

2021 GOST R 59769-2021 Medical devices. Risk management. Guide for risk analysis and risk assessment process planning