DIN EN ISO 11608-5:2013
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012
- Standard No.
- DIN EN ISO 11608-5:2013
- Release Date
- 2013
- Published By
- German Institute for Standardization
- Status
- Replace By
- DIN EN ISO 11608-5 E:2020
- Latest
- DIN EN ISO 11608-5:2023-05
- Replace
- DIN EN ISO 11608-5:2010
- 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.
DIN EN ISO 11608-5:2013 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
DIN EN ISO 11608-5:2013 history
- 2023 DIN EN ISO 11608-5:2023-05 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022); German version EN ISO 11608-5:2023
- 2023 DIN EN ISO 11608-5:2023 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2022)
- 1970 DIN EN ISO 11608-5 E:2022-11 Requirements and test methods for medical pen injectors Part 5: Automatic functions (draft)
- 1970 DIN EN ISO 11608-5 E:2020-05 Requirements and test methods for medical pen injectors Part 5: Automatic functions (draft)
- 2020 DIN EN ISO 11608-5 E:2020 Draft Document - Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO/DIS 11608-5:2020); German and English version prEN ISO 11608-5:2020
- 2013 DIN EN ISO 11608-5:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012); German version EN ISO 11608-5:2012
- 1970 DIN EN ISO 11608-5 E:2010-11 Requirements and test methods for medical pen injectors Part 5: Automatic functions (draft)
- 0000 DIN EN ISO 11608-5:2010
