ISO 11608-1:2022/Amd 1:2026
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems — Amendment 1
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 3
- Дата публикации:
- 24 апреля 2026 г.
- Издание:
- ISO IS 11608 edition 4 version 1
- ICS:
- 11.040.25
Abstract
Overview
ISO 11608-1:2022/Amd 1:2026 is the first amendment to ISO 11608-1:2022, focusing on needle-based injection systems (NIS) for medical use. Developed by the International Organization for Standardization (ISO), this amendment refines requirements and test methods that ensure the safety, accuracy, and reliability of needle-based injection devices. The standard addresses key criteria for primary functionality, performance testing, and product lifecycle evaluation, reinforcing quality benchmarks essential for medical device manufacturers and stakeholders in the healthcare sector.
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