ONORM 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
20-01-2024
12-01-2013
Dieser Teil der EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er enthält Anforderungen für die Kennzeichnung und die Angaben von Informationen über die angewendeten Prüfmethoden. Diese ÖNORM legt Prüfverfahren für die Biokompatibilität und Anforderungen an die Kennzeichnung der Biokompatibilität medizinischer Handschuhe zum einmaligen Gebrauch fest. Diese Norm enthält ebenfalls einen Überblick über immunologische Verfahren für die Bestimmung löslicher Proteine und Allergene.
| Committee |
TC 179
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| I.S. EN 455-3:2015 | Identical |
| SN EN 455-3 : 2015 | Identical |
| UNI EN 455-3 : 2007 | Identical |
| UNE-EN 455-3:2015 | Identical |
| 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 |
| ONORM EN 13718-2 : 2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| ONORM EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ONORM EN ISO 10993-10 : 2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 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 |
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