ISO 11608-3:2022/Amd 1:2026
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 5
- Дата публикации:
- 17 апреля 2026 г.
- Издание:
- ISO IS 11608 edition 3 version 1
- ICS:
- 11.040.25
Abstract
Overview
ISO 11608-3:2022/Amd 1:2026 is an international standard amendment focused on needle-based injection systems (NIS) for medical use, specifically addressing requirements and test methods for containers and integrated fluid paths. Developed by ISO Technical Committee 84 in collaboration with CEN, this amendment aligns with current regulatory requirements and harmonizes practices for managing particulate contamination in needle-based injection system components. The standard provides updated guidelines for testing and verifying that containers and integrated fluid paths in NIS maintain safety, quality, and compatibility with medicinal products.
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