ISO 11608-5:2012
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
- Standard No.
- ISO 11608-5:2012
- Release Date
- 2012
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 11608-5:2022
- Latest
- ISO 11608-5:2022
- Scope
- This part of ISO 11608 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans, including but not limited to: a) drug product preparation (e.g. reconstitution); b) needle preparation; c) air removal; d) priming; e) dose setting; f) actuation; g) needle insertion; h) injection of the medicinal product; i) disabling the NIS-AUTO; j) needle retraction; k) needle shielding; l) needle hiding; m) sharps injury protection; n) needle removal.
ISO 11608-5:2012 Referenced Document
- IEC 62366 Medical devices - Application of usability engineering to medical devices*， 2014-01-01 Update
- ISO 11608-1 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems*， 2022-04-07 Update
- ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 11608-5:2012 history
- 2022 ISO 11608-5:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
- 2012 ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
