PREN 455-3 : DRAFT 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
19-06-2013
01-04-2015
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Test report
Annex A (normative) - Method for the determination
of aqueous extractable proteins in natural
rubber gloves using the modified Lowry assay
Annex B (informative) - Immunological methods for
the measurements of natural rubber latex
allergens
Annex C (informative) - Amino acid analysis (AAA)
by high pressure liquid chromatography (HPLC)
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Medical Devices
Defines requirements for the evaluation of biological safety for medical gloves for single use.
| Committee |
TC 205
|
| DocumentType |
Draft
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| 13/30281504 DC : 0 | Identical |