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UNE-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
Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

06-03-2015

Publisher

Asociacion Espanola de Normalizacion

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 evaluating biological safety for single use medical gloves.

Committee
CTN 111
DocumentType
Standard
Pages
40
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
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
I.S. EN 455-3:2015 Identical
SN EN 455-3 : 2015 Identical
UNI EN 455-3 : 2007 Identical
BS EN 455-3:2015 Identical
EN 455-3:2015 Identical
DIN EN 455-3:2015-07 Identical
ONORM EN 455-3 : 2015 Identical

EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
ASTM D 5712 : 2015 : REDLINE Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 21171:2006 Medical gloves - Determination of removable surface powder (ISO 21171:2006)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 21171:2006 Medical gloves — Determination of removable surface powder
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ASTM D 7427 : 2016 : REDLINE Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex
EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)

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Hardcopy - Spanish
PDF - Spanish
Hardcopy - English
PDF - English
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