BS EN ISO 8536-4:2020 pdf download.Infusion equipment for medical use
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
ISO 14644‑1, 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
ISO 80369‑7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
4 General requirements
4.1 The nomenclature to be used for components of infusion sets and of a stand‑alone air‑inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results.
5 Designation
Designation shall follow label requirements according to Clause 10.
6 Materials
The materials from which the infusion set, its components and the stand‑alone air‑inlet device are manufactured (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 comply with the requirements specified in Clauses 8 and 9.
7.1 Particulate contamination
The infusion set and stand‑alone air‑inlet device shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.2, the number of particles shall not exceed the contamination index limit.
BS EN ISO 8536-4:2020 pdf download
