I.S. EN 455-3:2015
Superseded
View Superseded by
MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
Hardcopy , PDF
English
01-01-2015
12-07-2023
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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. Also provides requirements for labelling and the disclosure of information relevant to the test methods used.
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN 455-3 : 2015 | Identical |
| NBN EN 455-3 : 2015 | Identical |
| NEN EN 455-3 : 2015 | Identical |
| NS EN 455-3 : 1999 | Identical |
| BS EN 455-3:2015 | Identical |
| EN 455-3:2015 | Identical |
| DIN EN 455-3:2015-07 | Identical |
| UNE-EN 455-3:2015 | Identical |
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