Table of Contents

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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and testing rationale<br>Annex B (normative) - One- and two-sided tolerance<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;limit factors, k<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential Requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EU Directive 93/42/EEC

Abstract

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

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/84
Supersedes	97/563387 DC : AUG 97 10/30208977 DC : 0