I.S. EN 455-3:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
07-12-2023
English
01-01-2015
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
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.
| DocumentType |
Standard
|
| Pages |
38
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| 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 |
| SN EN 455-3 : 2015 | Identical |
| UNI EN 455-3 : 2007 | Identical |
| BS EN 455-3:2015 | Identical |
| UNE-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 |
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