iocompatibility testing that should be considered in evaluating the safety-in-use of medical devices and materials.
The ISO Standard, Part 1, uses an approach to test selection that is very similar to the Tripartite Guidance. It also uses a tabular format (matrix) for laying out the test requirements based on the various factors discussed above. The matrix consists of two tables, "Initial Evaluation Tests for Consideration" and "Supplementary Evaluation Tests for Consideration."
It is important to the user that the labelling for the neonatal incubator and neonatal transport incubator bear clear, accurate, and complete information for use concerning any relevant indications for use, conditions and limitations of use, hazards, contraindications, and precautions in their use.
Compiled by: John Sandham IEng MIIE MIHEEM