NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2013

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Information supplied by the manufacturer
Bibliography

Describes the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1.

DocumentType	Standard
Pages	18
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NF EN ISO 11608-3 : 2012	Identical
NEN EN ISO 11608-3 : 2012	Identical
I.S. EN ISO 11608-3:2012	Identical
NS EN ISO 11608-3 : 2012	Identical
EN ISO 11608-3:2012	Identical
SN EN ISO 11608-3:2012	Identical
UNI EN ISO 11608-3 : 2013	Identical
BS EN ISO 11608-3:2012	Identical
ISO 11608-3:2012	Identical
UNE-EN ISO 11608-3:2013	Identical
NBN EN ISO 11608-3 : 2012	Identical

DIN EN ISO 11608-2 E : 2012

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)

ISO 13926-1:2004	Pen systems Part 1: Glass cylinders for pen-injectors for medical use
ISO 8537:2016	Sterile single-use syringes, with or without needle, for insulin
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
DIN ISO 13926-1:2005-10	PEN SYSTEMS - PART 1: GLASS CYLINDERS FOR PEN-INJECTORS FOR MEDICAL USE
ISO 11608-1:2014	Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11040-3:2012	Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
ISO 11608-2:2012	Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
ISO 7886-1:2017	Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 13926-2:2011	Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
DIN EN ISO 9000:2015-11	QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015)
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
DIN EN ISO 7886-1 E : 1997	STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE

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DIN EN ISO 11608-3 E : 2013

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory

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