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BS EN 455-3:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Medical gloves for single use Requirements and testing for biological evaluation
Available format(s)

Hardcopy , PDF

Superseded date

07-12-2023

Language(s)

English

Published date

30-04-2015

Publisher

British Standards Institution

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.

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Committee
CH/205/3
DevelopmentNote
Together with BS EN 455-1 & BS EN 455-2 supersedes BS 4005(1996). Supersedes 96/563158 DC. (09/2005) Supersedes 13/30281504 DC. (04/2015)
DocumentType
Standard
Pages
38
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
I.S. EN 455-3:2015 Identical
SN EN 455-3 : 2015 Identical
UNI EN 455-3 : 2007 Identical
UNE-EN 455-3:2015 Identical
NS EN 455-3 : 1999 Identical
NBN EN 455-3 : 2015 Identical
NF EN 455-3 : 2015 Identical
EN 455-3:2015 Identical
NEN EN 455-3 : 2015 Identical
DIN EN 455-3:2015-07 Identical
ONORM EN 455-3 : 2015 Identical

BS 6183-4:2001 Protective equipment for cricketers Gloves for batsmen

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 - English
PDF - English
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