Standard Number | BS EN ISO 10993-13:2010 |
Title | Biological evaluation of medical devices. Identification and quantification of degradation products from polymeric medical devices |
Status | Confirmed, Current |
Publication Date | 31 October 2010 |
Conformity to regulation | Designated |
Confirm Date | 02 May 2019 |
Normative References(Required to achieve compliance to this standard) | ISO 3696, ISO 10993-12, ISO 10993-1, ISO 10993-9, ISO 10993-17 |
Informative References(Provided for Information) | 90/385/EEC, 93/42/EEC, ISO 14971, ISO 13781:2017 |
Replaces | BS EN ISO 10993-13:2009 |
International Relationships | EN ISO 10993-13:2010,ISO 10993-13:2010 |
Draft Superseded By | 08/30156451 DC |
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 |
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 |
Title in German | Biologische Beurteilung von Medizinprodukten. Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Polymeren |
Committee | CH/194 |
ISBN | 978 0 580 57719 2 |
Publisher | BSI |
Format | A4 |
Delivery | Yes |
Pages | 28 |
File Size | 1.33 MB |
Price | £186.00 |