ISO 8536-4:2019 PDF

Scope: This document 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 this document 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.

ISO 8536-4:2019 Referenced Document

ISO 14644-1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (includes Redline Version)
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 3696 Water for analytical laboratory use; Specification and test methods
ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods
ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*， 2021-04-30 Update

2019 ISO 8536-4:2019 Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
2013 ISO 8536-4:2010/Amd 1:2013 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed; Amendment 1
2010 ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
2007 ISO 8536-4:2007 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
2004 ISO 8536-4:2004 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
1998 ISO 8536-4:1998 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
1987 ISO 8536-4:1987 Infusion equipment for medical use; Part 4 : Infusion sets for single use