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NEN EN 455-3 : 2015

Current

Current

The latest, up-to-date edition.

MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION

Published date

01-12-2013

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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