GB/T 44353.1-2024 Active

This document applies to medical devices manufactured from animal-derived materials (inactive or inactivated), and does not apply to in vitro diagnostic medical devices. In conjunction with ISO 14971, this document specifies procedures for identifying hazards and hazardous situations associated with such devices, estimating, evaluating, and controlling the resulting risks, and monitoring the effectiveness of these controls. Additionally, this document provides a decision-making process for determining the acceptability of residual risks defined by ISO 14971 compared to the anticipated clinical benefits of existing devices. This document provides requirements and guidance for risk management of typical hazards associated with medical devices manufactured from animal tissues or their derivatives, including:
a) contamination by bacteria, mold, or yeast;
b) viral contamination;
c) contamination by transmissible spongiform encephalopathy (TSE) agents;
d) unintended pyrogenic, immunological, or toxicological responses caused by materials.
Similar principles may apply to parasites or other unclassified pathogens.
Except for some specific derivatives mentioned in Appendix C, this document does not specify acceptable levels, as these depend on multiple factors and cannot be uniformly specified in a standard. Appendix C provides TSE risk acceptability levels for animal fat derivatives, animal charcoal, milk and milk derivatives, wool derivatives, and amino acids.
This document does not address quality management systems for all stages of medical device production.
This document does not include medical devices that use human tissues.