ISO 11608-1:2000 PDF

Scope: This part of ISO 11608 specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable prefilled cartridges. This part of ISO 11608 is also applicable to pen-injectors which are not electrically driven, but are equipped with electronic components. This part of ISO 11608 is not applicable to high-pressure injectors and electrically driven injectors.

ISO 11608-1:2000 Referenced Document

IEC 60068-2-30:1980 Basic environmental testing procedures. Part 2 : Tests. Test Db and guidance: Damp heat, cyclic (12 + 12-hour cycle)
IEC 60068-2-6:1995 Environmental testing - Part 2: Tests - Test Fc: Vibration (sinusoidal)
IEC 61000-4-2:1999 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
IEC 61000-4-3:1998 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
ISO 11608-2:2000 Pen-injectors for medical use - Part 2: Needles; Requirements and test methods
ISO 11608-3:2000 Pen-injectors for medical use - Part 3: Finished cartridges; Requirements and test methods

2022 ISO 11608-1:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
2014 ISO 11608-1:2014 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
2012 ISO 11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
2000 ISO 11608-1:2000 Pen-injectors for medical use - Part 1: Pen-injectors; Requirements and test methods