BS 06/30106186 DC

ISO 10993-1. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management system British Standards Institution / 14-Nov-2006 / 29 pages

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Cross References: ISO 10993-2*ISO 10993-3*ISO 10993-4*ISO 10993-5*ISO 10993-6*ISO 10993-7*ISO 10993-9*ISO 10993-10*ISO 10993-11*ISO 10993-12 *ISO 10993-13*ISO 10993-14*ISO 10993-15*ISO 10993-16*ISO 10993-17*ISO 10993-18*ISO/TS 10993-19*ISO TS 10993-20*ISO 14971*ISO 7405:1997*ISO 9000:2000*ISO 9001:2000*ISO 9004:2000*ISO 13485:2003*

Keywords: Medical equipment; Biological analysis and testing ; Medical instruments; Medical technology; Biological hazards; Dental equipment; Dental materials ; Implants (surgical); Therapeutics; Clinical investigation instruments; Bioassay; Cytotoxicity tests ; Contaminants; Compatibility

Product Code(s): 30106186

This product references:ISO 10993-4:1992 - Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ISO 10993-3:1992 - Biological evaluation of medical devices; part 3: tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 9004:2000 - Quality management systems -- Guidelines for performance improvements
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 7405:1997 - Dentistry -- Preclinical evaluation of biocompatibility of medical devices used in dentistry -- Test methods for dental materials
ISO 9001:2000 - Quality management systems -- Requirements