UNE-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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Spanish, Castilian, English
03-06-2015
19-06-2024
Foreword
Introduction
1 Scope
2 Normative references
3 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 determination
of leachable proteins and allergens
from medical gloves
Annex C (informative) Amino acid analysis (AAA) by high
pressure liquid chromatography (HPLC)
Annex D (informative) Glossary
Annex E (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements and
other provisions of EU Directives
Defines requirements for evaluating biological safety for single use medical gloves.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NS EN 455-3 : 1999 | Identical |
| BS EN 455-3:2015 | 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 |
| I.S. EN 455-3:2015 | 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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