Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%) в рублях |
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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 - Part14:Identification and quantification of degradation products from ceramics
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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:Establishment of allowable limits for leachable substances
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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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Prefilled syringes - Part 1: Glass cylinders for dental local anaesthetic cartridges
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Prefilled syringes - Part 2: Plunger stoppers for dental local anaesthetic cartridges
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