NEN EN 455-3 : 2015
Current
The latest, up-to-date edition.
MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
12-01-2013
Foreword
Introduction
1 Scope
2 Normative references
3 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 determination
of leachable proteins and allergens
from medical gloves
Annex C (informative) Amino acid analysis (AAA) by high
pressure liquid chromatography (HPLC)
Annex D (informative) Glossary
Annex E (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements and
other provisions of EU Directives
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.
| DevelopmentNote |
Draft AMD 1 2016 issued on November 2016. (01/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN 455-3:2015 | Identical |
| SN EN 455-3 : 2015 | Identical |
| UNE-EN 455-3:2015 | Identical |
| DIN EN 455-3:2015-07 | Identical |
| EN 455-3:2015 | Identical |
| UNI EN 455-3 : 2007 | Identical |
| NS EN 455-3 : 1999 | Identical |
| BS EN 455-3:2015 | Identical |
| ONORM EN 455-3 : 2015 | Identical |
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