Overview

This International Standard covers sterile, single-use hypodermic needles intended primarily for injecting or withdrawing fluids from the human body. The plastic materials to be used in the manufacture of needles are not specified, as their selection depends to some extent on the design, manufacturing processes and sterilization procedure used by individual manufacturers. The hypodermic needles specified in this International Standard are intended for use with syringes with 6% Luer taper connections as specified in ISO/DIS 80369-7) in conjunction with ISO 80369-1 and ISO/DIS 80369-20). For devices/connections that are intended to mate with injection cannulae conforming to the International Standard but differ from those specified in ISO 80639-7, clear evidence of safe functioning shall be provided. In some countries, national Official Pharmacopoeias or regulatory requirements are legally binding and requirements contained therein may take precedence over this International Standard. Guidance on transition periods for implementing the requirements of this International Standard is given in ISO/TR 19244 "Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters". This document (EN ISO 7864:2016) has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and catheters" (secretariat: DS, Denmark) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN. At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 84 - Devices for administration of medicinal products and catheters