PREN 455-3 : DRAFT 2013

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

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Superseded date: 01-04-2015

Language(s):

Published date: 19-06-2013

Publisher: Comite Europeen de Normalisation

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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

Abstract - (Show below) - (Hide below)

Defines requirements for the evaluation of biological safety for medical gloves for single use.

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Comment Closes On
Committee	TC 205
Document Type	Draft
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Superseded
Superseded By	EN 455-3:2015

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Equivalent Standard(s)	Relationship
13/30281504 DC : 0	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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