Skip to main content
Back

EVS-EN ISO 7886-1:2018

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected version 2019-08)

General information

Valid from 16.04.2018
Base Documents
ISO 7886-1:2017; EN ISO 7886-1:2018
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.04.2018
Main
01.01.2000
Main
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.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Customers who bought this item also bought

Main

EVS-EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
Newest version Valid from 04.10.2016
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019
Main

EVS-EN 556-1:2002

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices.
Newest version Valid from 06.05.2002
Main

EVS-EN ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
Newest version Valid from 04.10.2016