| Standard Number | BS EN ISO 10993-13:2010 |
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| Title | Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices |
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| Status | Confirmed, Current |
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| Publication Date | 31 October 2010 |
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| Confirm Date | 02 May 2019 |
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| Normative References(Required to achieve compliance to this standard) | ISO 3696, ISO 10993-12, ISO 10993-1, ISO 10993-9, ISO 10993-17 |
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| Informative References(Provided for Information) | 90/385/EEC, 93/42/EEC, ISO 14971, ISO 13781:2017 |
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| Replaces | BS EN ISO 10993-13:2009 |
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| International Relationships | EN ISO 10993-13:2010,ISO 10993-13:2010 |
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| Draft Superseded By | 08/30156451 DC |
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| Descriptors | Decomposition reactions, Biological analysis and testing, Degradation, Identification methods, Testing conditions, Biology, Polymers, Quantitative analysis, Accelerated testing, Medical equipment, Deterioration, Chemical analysis and testing |
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| ICS | 11.100.20
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| Title in French | Évaluation biologique des dispositifs médicaux. Identification et quantification de produits de dégradation de dispositifs médicaux à base de polymères |
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| Title in German | Biologische Beurteilung von Medizinprodukten. Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren |
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| Committee | CH/194 |
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| ISBN | 978 0 580 57719 2 |
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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 | 1.33 MB |
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| Price | £182.00 |
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