PREN ISO 11608-5 : DRAFT 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 5: AUTOMATED FUNCTIONS
01-10-2012
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Test report
7 Information to be supplied by the manufacturer
Annex A (informative) - Rationale for requirements
Annex ZA (informative) - Relationship between this
International Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Defines requirements and test methods for the needle-based injection systems with automated functions for the administration of medicinal products.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| Standards | Relationship |
| DIN EN ISO 11608-5:2013-01 | Identical |
| 10/30213842 DC : 0 | Identical |
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