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ISO 8536-4:2010

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.


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International Organization for Standardization [iso]


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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