ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements - Third Edition
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
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- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
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- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
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- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 97.140
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- CEI EN 61496-2 Safety of machinery - Electro-sensitive protective equipment Part 2: Particular requirements for equipment using active opto-electronic protective devices (AOPDs)
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- Картотека зарубежных и международных стандартов
International Organization for Standardization
Sterilization of health care products - Biological indicators - Part 1: General requirements - Third Edition
N 11138-1
Annotation
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
This document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Автоматический перевод:
Стерилизация продуктов здравоохранения - индикаторов Biological - Часть 1: Общие требования - Третий Выпуск
Этот документ указывает общие требования для производства, маркировки, методов тестирования и показателей производительности биологических индикаторов, включая привитых поставщиков услуг и приостановки и их компоненты, чтобы использоваться в проверке и стандартном контроле процессов стерилизации.
