EN ISO 11608-3:2022/A1:2026
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths - Amendment 1 (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 (ISO 11608-3:2022/Amd 1:2026)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 29 апреля 2026 г.
- Издание:
- CEN EN 11608 edition 1 version 1
- ICS:
- 11.040.25
Abstract
Overview
EN ISO 11608-3:2022/A1:2026 specifies updated requirements and test methods for containers and integrated fluid paths in needle-based injection systems (NIS) for medical use. Issued by CEN as an amendment to , this standard focuses on the assessment and management of particulate matter within the reservoir and fluid path, with a sustained emphasis on patient safety and product functionality. The document addresses harmonization with relevant pharmacopoeial standards and incorporates a new Annex to clarify particulate requirements and their underlying rationale.
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