Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems - Amendment 1
Abstract
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems (NIS) intended for single-patient use to deliver separate volumes of drug (boluses) through cannulae or soft needles for intradermal, subcutaneous and/or intramuscular administration and containing prefilled or user-filled, renewable or non-renewable containers. - This amendment addresses editorial inconsistencies with regards to terminology introduced in the last revision, e.g. use of "anticipated/normal conditions" vs. "in-use conditions" and interchangeable and inconsistent use of "conditioning" and "preconditioning". - In addition, it tries to improve subclause 10.2 with regards to the sequence of visual inspection and assessment of primary functions. - It does not introduce new requirements, and it does not change existing requirements.
Begin
2024-10-18
WI
00205412
Planned document number
DIN EN ISO 11608-1/A1
Project number
17600123
Responsible national committee
NA 176-04-02 AA - Injection systems
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 84/WG 3 - Needle-based injection systems - Injector, container and pen needle
