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Subject: испытания на биосовместимость med.appl. Перевожу сертификаты, подтверждающие биосовместимость материалов, используемых в фистульных иглах. В сертификате говорится:"We herewith confirm for the above material that the following tests are carried out for validation lot: - Systemic Injection Test according to USP 29 - Intracutaneous Reaction Test according to USP 29 - Implantation Test according to USP 29" Интересует перевод названий испытаний: |
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Навскидку может поможет: These tests are designed to determine the biological response of animals to elastomerics, plastics and other polymeric material with direct or indirect patient contact, or by the injection of specific extracts prepared from the material under test. Three tests are described: 1. Systemic Injection Test – Designed to determine the systemic biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample. 2. Intracutaneous Test – Designed to determine the local biological responses of animals to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample. 3. Implantation Test – Designed to evaluate the reaction of living tissue to the plastic and other polymers by the implantation of the sample (specimen under test) itself into animal tissue. "validation lot" = валидационная серия/партия (в зависимости от глоссария заказчика и контекста), т.е. это партия/серия, изготовленная для выполнения валидационного исследования (с целью валидации лекарственного продукта, методики исследований, производственного процесса и т.д.) |
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