• There are no items in your cart

DIN EN ISO 11608-2:2012-12

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
Available format(s)

Hardcopy , PDF

Superseded date

08-29-2022

Language(s)

English, German

Published date

12-01-2012

Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Colour coding
4.2 Materials
4.3 Dimensions
4.4 Patency of lumen
4.5 Needle points
4.6 Freedom from defects
4.7 Lubrication
4.8 Dislocation of measuring point at the patient-
    end of type A needles
4.9 Bond between hub and needle tube
4.10 Unscrewing torque of the needle
4.11 Ease of assembly/disassembly
4.12 Sterility
5 Sampling
6 Preconditioning of needles
6.1 Preconditioning in dry heat atmosphere
6.2 Preconditioning in cold storage atmosphere
6.3 Preconditioning in cyclical atmosphere
7 Standard atmosphere and apparatus for tests
7.1 Standard test atmosphere
7.2 Test apparatus
8 Determination of dislocation of measuring point
    at the patient-end of Type A needles
9 Bond between hub and needle tube
10 Unscrewing torque of the needle
11 Packaging
12 Information supplied by the manufacturer
12.1 General
12.2 Marking
12.3 Instructions for use
Bibliography

Describes requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

DocumentType
Standard
Pages
25
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 11608-4:2016-03 (Draft) PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

DIN ISO 7000:2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
DIN EN ISO 7864:2015-01 (Draft) STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO 7864:2016)
DIN EN ISO 11608-3:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
DIN EN ISO 11608-1:2015-04 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
ISO 15510:2014 Stainless steels Chemical composition
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
DIN ISO 2859-1:2014-08 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES - PART 1: SAMPLING SCHEMES INDEXED BY ACCEPTANCE QUALITY LIMIT (AQL) FOR LOT-BY-LOT INSPECTION (ISO 2859-1:1999 + COR. 1:2001 + AMD.1:2011)
ISO/IEC Guide 98-1:2009 Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
DIN EN 60068-2-30:2006-06 ENVIRONMENTAL TESTING - PART 2-30: TESTS - TEST DB: DAMP HEAT, CYCLIC (12 H + 12 H CYCLE)
ISO 11608-3:2012 Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
DIN EN ISO 9626:2015-03 (Draft) STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
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
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

View more information
US$117.82
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.