| Standard Number | BS EN ISO 18113-2:2011 |
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| Title | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use |
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| Status | Current |
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| Publication Date | 30 November 2011 |
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| Cross References | ISO 8601, ISO 14971, ISO 15223-1, ISO 18113-1, EN 980, ISO 17511, ISO 18113-3, ISO 18153, ISO/IEC Directives Part 2, EN 375:2001, CLSI C28-A2:2000, CLSI GP10-A:1995, 98/79/EC |
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| Replaces | BS EN ISO 18113-2:2009 |
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| International Relationships | EN ISO 18113-2:2011 Identical, ISO 18113-2:2009 Identical |
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| Amended By | Corrigendum January 2012. |
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| Descriptors | Diagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Containers, Health service personnel |
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| ICS | 11.100.10 (In vitro diagnostic test systems)
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| Title in French | Dispositifs médicaux de diagnostic in vitro. Informations fournies par le fabricant (étiquetage). Réactifs de diagnostic in vitro à usage professionnel |
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| Title in German | In-vitro-Diagnostika. Bereitstellung von Informationen durch den Hersteller. In-vitro-diagnostische Reagenzien für den Gebrauch durch Fachpersonal |
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| Committee | CH/212 |
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| ISBN | 978 0 580 77328 0 |
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| Publisher | BSI |
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| Format | A4 |
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| Delivery | YES |
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| Pages | 24 |
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| File Size | 1.577 MB |
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| Price | £ 140.00 |
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