ГОСТ Р ИСО 25424-2013-医疗器械灭菌低温蒸汽和甲醛对医疗器械灭菌过程的开发验证和常规控制的要求-国家数字标准馆

现行 ГОСТ Р ИСО 25424-2013

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Стерилизация медицинских изделий. Стерилизация низкотемпературная пароформальдегидная. Требования к разработке, валидации и рутинному контролю процесса стерилизации 医疗器械灭菌低温蒸汽和甲醛对医疗器械灭菌过程的开发验证和常规控制的要求

实施日期： 2015-01-01

此标准规定了开发，验证和常规控制灭菌过程的低温paroformaldegidnogo（LTSF）医疗器械的要求。
   本标准适用于应用程序开发者，灭菌设备的厂家，医疗设备制造商项目进行消毒，以及负责医疗器械的消毒组织

Настоящий стандарт определяет требования к разработке, валидации и текущему контролю низкотемпературного пароформальдегидного процесса стерилизации (LTSF) медицинских изделий.
 Настоящий стандарт предназначен для применения разработчиками процессов, изготовителями стерилизационного оборудования, изготовителями медицинских изделий, подлежащих стерилизации, а также организациями, ответственными за стерилизацию медицинских изделий

分类信息

发布单位或类别：俄罗斯-俄罗斯国家标准

CCS分类： C30/49医药、卫生、劳动保护 - 医疗器械

ICS分类： 11.080.01消毒和灭菌 - 消毒和灭菌综合

关联关系

研制信息

起草单位： Общество с ограниченной ответственностью «Фармстер» (ООО «Фармстер»)

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