SIST 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:
- 18 мая 2026 г.
- Издание:
- ISO 11608-3:2022/Amd 1:2026
- ICS:
- 11.040.25
Abstract
Overview
SIST EN ISO 11608-3:2022/A1:2026 is an internationally harmonized amendment to ISO 11608-3, which specifies the requirements and test methods for containers and integrated fluid paths in needle-based injection systems (NIS) for medical use. This amendment provides updated guidance addressing key aspects such as particulate matter limits, updated normative references, and enhanced control strategies. The standard is crucial for manufacturers, suppliers, and regulators concerned with the safety and performance of injection pens and similar medical injectors.
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