YY/T 0771.1-2020 Active

This part of YY/T 0771 specifies procedures for identifying and addressing hazards (sources) and risk situations related to medical devices manufactured using animal-derived materials (inactivated or rendered inactive), estimating, evaluating, and controlling the resulting risks, and supervising the effectiveness of these controls (in conjunction with YY/T 0316-2016). This part applies to medical devices manufactured using animal-derived materials (inactivated or rendered inactive), excluding in vitro diagnostic medical devices. It does not apply to medical devices that use human tissues. This part does not specify a quality management system for controlling the entire production phase of medical devices. Additionally, considering the residual risks defined in YY/T 0316-2016 and weighing the anticipated medical benefits compared to other alternatives, this part provides a process for determining the acceptability of residual risks and requirements and guidelines for risk management of hazards (sources) related to medical devices manufactured using animal tissues or their derivatives, including: a) bacterial, fungal, or yeast contamination; b) viral contamination; c) contamination by transmissible spongiform encephalopathy (TSE) agents; d) unintended pyrogenic, immunological, or toxicological responses caused by materials. Similar principles also apply to parasites or other unclassified pathogens.