| Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%)
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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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На языке оригинала
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Пишите на gost@gostinfo.ru
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Biological evaluation of medical devices - Part 2: Animal welfare requirements
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Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
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Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
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Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
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Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
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Biological evaluation of medical devices - Part 20:Principles and methods for immunotoxicology testing of medical devices
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Biological evaluation of medical devices - Part 23: Tests for irritation
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Medical products containing viable human cells - Application of risk management and requirements for processing practices
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Clinical investigation of medical devices for human subjects - Good clinical practice
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