DS/EN ISO 7886-1:2018

Sterile hypodermic syringes for single use – Part 1: Syringes for manual use (ISO/FDIS 7886-1:2016)


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 86.05

Scope

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.

Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.

It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).

Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.


Number of pages: 44

Published: 2018-04-06

Date of approval: 2018-04-03

International relationships : EN ISO 7886-1:2018 IDT ISO 7886-1:2017 IDT

ICS: 11.040.25 -

Syringes, needles and catheters

Item number: M300524


Committees

Committee

  • CEN/TC 205
  • ISO/TC 84

Danish committee

DS/S-093