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13/30281504 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION
Available format(s)

Hardcopy , PDF

Superseded date

04-30-2015

Language(s)

English

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

BS EN 455-3.

Committee
CH/205/3
DocumentType
Draft
Pages
37
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

Standards Relationship
PREN 455-3 : DRAFT 2013 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 - English
PDF - English
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