Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
DIN EN 455-3:2007-03 (E)
Medical gloves for single use – Part 3: Requirements and testing for biological
evaluation
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Requirements …………………………………………………………………………………………………………………6
5 Test methods ………………………………………………………………………………………………………………….8
6 Test report ………………………………………………………………………………………………………………………9
Annex A (normative) Method for the determination of aqueous extractable proteins in natural
rubber gloves using the modified Lowry assay ………………………………………………………………10
Annex B (informative) Immunological methods for the measurement of natural rubber latex
allergens ……………………………………………………………………………………………………………………….20
Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography (HPLC) 27
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices ……………………………………………..36