BS EN ISO 8536-4:2020 pdf free.Infusion equipment for medical use — Infusion sets for single use, gravity feed.
This document specifies requirements for single use,gravity feed infusion sets for medical use in orderto 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 andperformance of materials used in infusion sets and to present designations for infusion set components.
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references,only the edition cited applies. Forundated references, the latest edition of the referenced document(including any amendments) applies.ISo 3696,Water for analytical laboratory use — Specification and test methods
ISO 7864,Sterile hypodermic needles for single use — Requirements and test methods
ISO 8536-13, Infusion equipment for medical use — Part 13:Graduated flow regulators for single use withfluid contact
ISO 8536-14, Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusionand infusion equipment without fluid contact
ISO 14644-1,Cleanrooms and associated controlled environments—Part 1: Classification of air cleanlinessby particle concentration
IS0 15223-1, Medical devices —Symbols to be used with medical device labels, labelling and information tobe supplied— Part 1: General requirements
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications —Part 7: Connectorsfor intravascular or hypodermic applications.
The nomenclature to be used for components of infusion sets and of a stand-alone air-inlet deviceis given in Figures 1, 2 and 3.These figures illustrate examples of the configuration of infusion sets andair-inlet devices; other configurations may be used provided they lead to the same results.Infusion sets.
The materials from which the infusion set, its components and the stand-alone air-inlet device aremanufactured (as described in Clause 4) shall comply with the requirements specified in Clause 7.Where components of the infusion set come into contact with solutions, the materials shall also complywith the requirements specified in Clauses 8 and 9.
The infusion set and stand-alone air-inlet device shall be manufactured under conditions that minimizeparticulate contamination.All parts shall be smooth and clean at the fluid pathway surfaces. Whentested as specified in A.2, the number of particles shall not exceed the contamination index limit.BS EN ISO 8536 pdf download.