Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: BS EN ISO 11608-1-TC:2020
• Năm ban hành / Publication date: 2020
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Tracked Changes (Redline) - Needle-based injection systems for medical use — Requirements and test methods Part 1: Needle-based injection systems
• Chỉ số phân loại Quốc tế (ICS) / By field: 11.040.25 - Bơm kim tiêm, kim tiêm và ống thông
• Số trang / Page: 108

Phạm vi áp dụng / Scope of standard

This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in this part of ISO 11608 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.

Additional guidance for NISs equipped with electronic or electromechanical components and NISs equipped with automated functions is given in ISO 11608-4 and ISO 11608-5 respectively.

Needle-free injectors, and requirements relating to methods or equipment associated with end-user filling of containers, are outside the scope of this part of ISO 11608.