Intravenous infusion sets have a large range of complexity and functionality and there are a variety of test requirements depending on the set and its accessory components to ensure that they’re compatible with infusion containers and IV equipment. ISO 8536 is the governing standard that specifies the requirements for infusion set testing, infusion containers and infusion set accessories.
The published parts of ISO 8536 are:
- ISO 8536-1 Infusion equipment for medical use – Part 1: Infusion glass bottles
- ISO 8536-2 Infusion equipment for medical use – Part 2: Closures for infusion bottles
- ISO 8536-3 Infusion equipment for medical use – Part 3: Aluminum caps for infusion bottles
- ISO 8536-4 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
- ISO 8536-5 Infusion equipment for medical use – Part 5: Burette infusion sets for single use, gravity feed
- ISO 8536-6 Infusion equipment for medical use – Part 6: Freeze drying closures for infusion bottles
- ISO 8536-7 Infusion equipment for medical use – Part 7: Caps made of aluminum-plastics combinations for infusion bottles
- ISO 8536-8 Infusion equipment for medical use – Part 8: Infusion sets for single use with pressure infusion apparatus
- ISO 8536-9 Infusion equipment for medical use – Part 9: Fluid lines for single use with pressure infusion equipment
- ISO 8536-10 Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment
- ISO 8536-11 Infusion equipment for medical use – Part 11: Infusion filters for single use with pressure infusion equipment
- ISO 8536-12 Infusion equipment for medical use – Part 12: Check valves
Overview of ISO 8536 Infusion Set & Equipment Testing
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