| Standard Number | BS EN ISO 10993-16:2017 |
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| Title | Biological evaluation of medical devices. Toxicokinetic study design for degradation products and leachables |
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| Status | Current |
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| Publication Date | 09 January 2018 |
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| Normative References(Required to achieve compliance to this standard) | ISO 10993-1:2009 |
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| Informative References(Provided for Information) | ISO 10993-18:2005, ISO/TR 10993-22:2017, ISO 10993-12:2012, ISO 10993-2:2006, ISO 14971:2007, ISO 10993-17:2002 |
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| Replaces | BS EN ISO 10993-16:2010 |
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| International Relationships | EN ISO 10993-16:2017,ISO 10993-16:2017 |
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| Amended By | Corrigendum, March 2020; Corrigendum, February 2018 |
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| Descriptors | Toxicology, Toxicity, Decomposition reactions, Absorption, Metabolism, Biological analysis and testing, Degradation, Design, Medical equipment, Leaching |
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| ICS | 11.100.20
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| Title in French | Évaluation biologique des dispositifs médicaux Conception des études toxicocinétiques des produits de dégradation et des substances relargables |
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| Title in German | Biologische Beurteilung von Medizinprodukten Entwurf und Auslegung toxikokinetischer Untersuchungen hinsichtlich Abbauprodukten und herauslösbaren Substanzen |
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| Committee | CH/194 |
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| ISBN | 978 0 539 13460 5 |
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| Publisher | BSI |
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| Format | A4 |
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| Delivery | Yes |
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| Pages | 28 |
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| File Size | 0.9863 MB |
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| Price | £186.00 |
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