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NS EN ISO 11608-4 : 1ED 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS
Superseded date

28-05-2022

Published date

12-01-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements
6 Test conditions
7 Preconditioning of pen-injectors
8 Reagent and apparatus
9 Determination of dose accuracy
10 Freedom from defects
11 Determination of electromagnetic compatibility
12 Electrical safety
13 Visual inspection
14 Functional inspection
15 Test report
16 Information supplied by the manufacturer
Bibliography

Defines requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.

DocumentType
Standard
PublisherName
Norwegian Standards (Norges Standardiseringsforbund)
Status
Superseded
SupersededBy

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