Name: PREN ISO 11608-2 : DRAFT 2010
Brand: CEN

PREN ISO 11608-2 : DRAFT 2010

Superseded

View Superseded by

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES

Superseded date

04-01-2012

Published date

01-12-2013

Publisher

Comite Europeen de Normalisation

1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Sampling
6 Pre-conditioning of needles
7 Standard atmosphere and apparatus
   for tests
8 Determination of dislocation of measuring
   point at the patient-end
9 Bond between hub and needle tube
10 Packaging
11 Test method for needle/injector systems
   compatibility validation
12 Information supplied by the manufacturer
Annex A (normative) - Determination of flow
        rate through needle
Bibliography

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

Committee	TC 205
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN ISO 11608-2:2012

Standards	Relationship
10/30209603 DC : 0	Identical

ISO 683-13:1974	Heat-treated steels, alloy steels and free-cutting steels Part 13: Wrought stainless steels
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 11608-1:2014	Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11608-3:2012	Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers
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 6009:2016	Hypodermic needles for single use Colour coding for identification
IEC 60068-2-30:2005	Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)