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DIN EN ISO 11608-1 E : 2015

Current
Current

The latest, up-to-date edition.

NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS (ISO 11608-1:2014)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Reagent and apparatus
7 Determination of dose accuracy
8 Preparation and operation of NISs
9 Test matrix
10 Test descriptions
11 Inspection
12 Test report
13 Information supplied by the manufacturer
Annex A (informative) - Dose replicates, accuracy
        and testing rationale
Annex B (normative) - One- and two-sided tolerance
        limit factors, k
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC
Bibliography

Defines requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers.

DocumentType
Standard
Pages
50
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Current

DIN EN ISO 11608-2 E : 2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012)
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IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
VDE 0750-241 : 2016 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
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ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

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