I.S. EN ISO 11608-5:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 11608-5:2012)
Hardcopy , PDF
23-03-2023
English
01-01-2012
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EC Directive 93/42/EEC
on medical devices
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