DIN EN ISO 11608-4:2007 PDF

Scope: This part of ISO 11608 specifies requirements and test methods for electromechanically driven injectors intended to be used with needles and with replaceable or non-replaceable cartridges.The injector may be for single-use or multiple-use.The injector system is intended to deliver medication to an end-user by self-administration or with assistance. This part of ISO 11608 is neither applicable for needle-free injectors(as covered in ISO 21649)nor infusion pumps(as covered in IEC 60601-2-24). This part of ISO 11608 is not applicable for devices that are capable of operating while connected to an external power supply.

DIN EN ISO 11608-4:2007 Referenced Document

IEC 60068-2-27:1987 Environmental testing. Part 2: Tests. Test Ea and guidance: Shock
IEC 60529:2001 Degrees of protection provided by enclosure (IP code)*， 2024-04-18 Update
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard: Electromagnetic compatibility; Requirements and tests
IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
ISO 11608-1:2000 Pen-injectors for medical use - Part 1: Pen-injectors; Requirements and test methods

2022 DIN EN ISO 11608-4:2022-09 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022); German version EN ISO 11608-4:2022
1970 DIN EN ISO 11608-4 E:2020-05 Requirements and test methods for medical needle injection systems Part 4: Needle injection systems containing electronic equipment (draft)
2020 DIN EN ISO 11608-4 E:2020 Draft Document - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2020); German and English version prEN ISO 11608-4:2020
2016 DIN EN ISO 11608-4:2016 Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO/DIS 11608-4:2016); German and English version prEN ISO 11608-4:2016
2007 DIN EN ISO 11608-4:2007 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006); English version of DIN EN ISO 11608-4:2007-11