CEN EN ISO 13408-1 Aseptic processing of health care products - Part 1: General requirements
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
- CEN EN ISO 13408-1 Aseptic processing of health care products - Part 1: General requirements
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- BSI BS ISO 14046 Environmental management — Water footprint — Principles, requirements and guidelines
- ISO 14064-1 Greenhouse gases Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals - First Edition
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- BSI BS ISO 14046 Environmental management — Water footprint — Principles, requirements and guidelines
- ISO 14064-1 Greenhouse gases Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals - First Edition
- BSI BS ISO 14046 Environmental management — Water footprint — Principles, requirements and guidelines
- ISO 14064-1 Greenhouse gases Part 1: Specification with guidance at the organization level for quantification and reporting of greenhouse gas emissions and removals - First Edition
- SNV SN EN ISO 14065 Greenhouse gases - Requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition
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- BSI BS EN 556-2 Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” Part 2: Requirements for aseptically processed medical devices
- Картотека зарубежных и международных стандартов
European Committee for Standardization
Aseptic processing of health care products - Part 1: General requirements
N EN ISO 13408-1
Annotation
This p art of I SO 13408 specifies t he general r equirements for, a nd offers g uidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.
This p art of I SO 13408 i ncludes r equirements a nd guidance relative t o the o verall t opic of a septic processing. Specific r equirements a nd guidance on various s pecialized processes and methods r elated to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.
NOTE This part of ISO 13408 does n ot s upersede or replace n ational r egulatory r equirements, such a s Good Manufacturing Practices ( GMPs) and/or p harmacopoeial requirements t hat pertain i n particular national or r egional jurisdictions.
Автоматический перевод:
Стерильная обработка продуктов здравоохранения - Часть 1: Общие требования
Это p искусство я ТАК 13408 определяю t он, общий r equirements для, без обозначения даты предлагает g uidance на, процессы, программы и процедуры для развития, проверки и обычного контроля производственного процесса для стерильным образом обработанных продуктов здравоохранения.
