BS EN ISO 8536-4:2020 pdf free.Infusion equipment for medical use  Infusion sets for single use , gravity feed.
BS EN ISO 8536-4 1 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.
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated 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 with fluid contact
ISO 8536-14, infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
150 146 44-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Air-inlet device
The air-inlet device can be an integral part of the infusion set (Figure 1) or a stand-alone device (Figure 3).
The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted.
When the air-inlet device is in use the air admitted into the container shall not become entrained in the liquid-entry of the closure-piercing device.
The air filter and the design of the air-inlet device shall be such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.5.2 and A.5.3.
The closure-piercing device or needle of the stand-alone device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.BS EN ISO 8536-4 pdf download.