CSA CAN/CSA-Z11135:15 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - First Edition
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CENELEC CLC/TR 62685 Industrial communication networks - Profiles - Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles (FSCPs)
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- CENELEC CLC/TR 62685 Industrial communication networks - Profiles - Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles (FSCPs)
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- CENELEC CLC/TR 62685 Industrial communication networks - Profiles - Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles (FSCPs)
- 35.100
- CENELEC CLC/TR 62685 Industrial communication networks - Profiles - Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles (FSCPs)
- 35.100.05
- CEI CLC/TR 62685 Industrial communication networks - Profiles - Assessment guideline for safety devices using IEC 61784-3 functional safety communication profiles (FSCPs)
- IEC 61326-3-1 CORR 1 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 3-1: Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) – General industrial applications CORRIGENDUM1 - Edition 1.0
- IEC 61326-3-1 CORR 1 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 3-1: Immunity requirements for safety-related systems and for equipment intended to perform safety-related functions (functional safety) – General industrial applications CORRIGENDUM1 - Edition 1.0
- Картотека зарубежных и международных стандартов
CSA Standards
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - First Edition
N CAN/CSA-Z11135:15
Annotation
Inclusions
[Add the following]
ISO 11135 specifies requirements and guidance for the development, validation, and routine control of an ethylene oxide (EO) sterilization process for medical devices. It applies to ethylene oxide sterilization in the context of medical device manufacturing and medical device reprocessing departments. Prevention of exposure to EO and its by-products during use is important for patient and occupational safety.
CSA Z314.23 and ISO 11135 are complementary Standards to be used together for sterilization using EO.
Автоматический перевод:
Стерилизация продуктов здравоохранения - Оксид этилена - Требования для развития, проверки и обычного контроля стерилизации обрабатывает для медицинских устройств - Первый Выпуск
Включения
[Добавьте следующий]
ISO 11135 определяет требования и руководство развитием, проверкой и обычным контролем процесса стерилизации оксида этилена (EO) для медицинских устройств. Это относится к стерилизации оксида этилена в контексте производства медицинских устройств и отделений переработки медицинского устройства. Профилактика выделения к EO и его побочным продуктам во время использования важна для безопасности пациентов и охраны труда.
