SN 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 (ISO 11608-2:2012)
Hardcopy
07-01-2012
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
ISO 11608/2 provides the requirements and test methods for single-use, double-ended, sterile needles for pen-injectors which fulfil the specifications of ISO 11608/1.
| Committee |
INB/NK 2205
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Swiss Standards
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 11608-2:2012 | Identical |
| UNE-EN ISO 11608-2:2012 | Identical |
| I.S. EN ISO 11608-2:2012 | Identical |
| NBN EN ISO 11608-2 : 2012 | Identical |
| DIN EN ISO 11608-2:2012-12 | Identical |
| UNI EN ISO 11608-2 : 2012 | Identical |
| NF EN ISO 11608-2 : 2012 | Identical |
| ISO 11608-2:2012 | Identical |
| NEN EN ISO 11608-2 : 2012 | Identical |
| BS EN ISO 11608-2:2012 | Identical |
| NS EN ISO 11608-2 : 2012 | Identical |
| ONORM EN ISO 11608-2 : 2012 | Identical |
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.