Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Requirements<br>5 Test methods<br>6 Test report<br>Annex A (normative) - Method for the determination of aqueous<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;extractable proteins in natural rubber gloves<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;using the modified Lowry assay<br>Annex B (informative) - Immunological methods for the measurements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of natural rubber latex allergens<br>Annex C (informative) - Amino acid analysis (AAA) by high<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;pressure liquid chromatography (HPLC)<br>Annex ZA (informative) - Relationship between this European<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Standard and the Essential Requirements of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EU Directive 93/42/EEC Medical Devices

Abstract

Defines requirements for the evaluation of biological safety for medical gloves for single use. Also provides requirements for labelling and the disclosure of information relevant to the test methods used.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/205/3
Supersedes	96/563158 DC : DRAFT SEP 1996 BS 4005(1996) : 1996 13/30281504 DC : 0