UNI EN ISO 7886-4 : 2009

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 4: SYRINGES WITH RE-USE PREVENTION FEATURE

Available format(s):

Superseded date: 12-09-2022

Language(s):

Published date: 31-12-2008

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

Table of Contents - (Show below) - (Hide below)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 Types of syringe
6 Cleanliness
7 Limits for acidity or alkalinity
8 Limits for extractable metals
9 Lubricant
10 Tolerance on graduated capacity
11 Graduated scale
12 Barrel
13 Piston/plunger assembly
14 Syringe nozzle/needle
15 Performance
16 Packaging
17 Labelling
Annex A (normative) - Method for preparation of extracts
Annex B (normative) - Test method for testing re-use
         prevention feature for RUP syringes
Annex C (informative) - Environmental aspects
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EC
         Directive 93/42/EEC on medical devices
Bibliography

Abstract - (Show below) - (Hide below)

Describes requirements for sterile single-use hypodermic syringes made of plastics materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.

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Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
Superseded By	UNI EN ISO 7886-4 : 2019
Supersedes	UNI EN ISO 7886-4 : 2007

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
NF EN ISO 7886-4 : 2009	Identical
EN ISO 7886-4:2009	Identical
NBN EN ISO 7886-4 : 2009	Identical
I.S. EN ISO 7886-4:2009	Identical
NS EN ISO 7886-4 : 2009	Identical
BS EN ISO 7886-4:2009	Identical
ONORM EN ISO 7886-4 : 2010	Identical
SN EN ISO 7886-4 : 2010	Identical
NEN EN ISO 7886-4 : 2009	Identical
UNE-EN ISO 7886-4:2010	Identical
ISO 7886-4:2006	Identical
DIN EN ISO 7886-4 E : 2010	Identical
DIN EN ISO 7886-4:2010-01	Identical

Standards Referencing This Book - (Show below) - (Hide below)

ISO 7886-3:2005	Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization
ISO 8537:2016	Sterile single-use syringes, with or without needle, for insulin
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 7886-2:1996	Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 780:2015	Packaging Distribution packaging Graphical symbols for handling and storage of packages
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols

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