NEN EN ISO 11608-2 : 2012
Current
The latest, up-to-date edition.
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES
12-01-2013
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
Defines requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfill the specifications of ISO 11608-1.
DocumentType |
Standard
|
PublisherName |
Netherlands Standards
|
Status |
Current
|
Standards | Relationship |
ONORM EN ISO 11608-2 : 2012 | Identical |
UNI EN ISO 11608-2 : 2012 | Identical |
UNE-EN ISO 11608-2:2012 | Identical |
EN ISO 11608-2:2012 | Identical |
ISO 11608-2:2012 | Identical |
BS EN ISO 11608-2:2012 | Identical |
NF EN ISO 11608-2 : 2012 | Identical |
I.S. EN ISO 11608-2:2012 | Identical |
NS EN ISO 11608-2 : 2012 | Identical |
DIN EN ISO 11608-2:2012-12 | Identical |
SN EN ISO 11608-2 : 2012 | Identical |
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