M00017622
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NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS
British Standards Institution
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Availability date: 11/05/2021
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Symbols and abbreviated terms<br>5 Requirements<br>6 Reagent and apparatus<br>7 Determination of dose accuracy<br>8 Preparation and operation of NISs<br>9 Test matrix<br>10 Test descriptions<br>11 Inspection<br>12 Test report<br>13 Information supplied by the manufacturer<br>Annex A (informative) - Dose replicates, accuracy<br> and testing rationale<br>Annex B (normative) - One- and two-sided tolerance<br> limit factors, k<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br> European Standard and the Essential Requirements<br> of EU Directive 93/42/EEC
Describes requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers.
Published | |
Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/84 |
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