When we look into the ISO 8536-4:2010 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed) and in this into the Annex A., which gives requirement of particulate matter and its assessment and acceptable value (N<90), how can we use this information as an input in the risk management to determine the clean room class that best suits the device.
The Annex A refers to counts of particulate matter of size 25-50 micron, 50-100 micron, and > 100 micron.
Many device types does fall into the typical single use infusion set, and any guidance on this will be most helpful.
The Annex A refers to counts of particulate matter of size 25-50 micron, 50-100 micron, and > 100 micron.
Many device types does fall into the typical single use infusion set, and any guidance on this will be most helpful.
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