Name: PREN 455-3 : DRAFT 2013
Brand: CEN

PREN 455-3 : DRAFT 2013

Superseded

View Superseded by

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

Superseded date

04-01-2015

Published date

06-19-2013

Publisher

Comite Europeen de Normalisation

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.

Committee	TC 205
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded
SupersededBy	EN 455-3:2015

Standards	Relationship
13/30281504 DC : 0	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)