ISO 11608-4:2006
ISO · 2006-03

Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors

Replaced Cited by 5

1Key Takeaways

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-ad…

2Scope / Description

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.

3Version History

ISO 11608-4:2006 2006-03
ISO 11608-4:2022 newer 2022-04-07

4Standard Metadata

Standard Number
ISO 11608-4:2006
Status
Replaced
Publisher
International Organization for Standardization (ISO)
Publication Date
2006-03
Adopted Standard
DIN EN ISO 11608-4-2007,IDT;DIN EN ISO 11608-4-2007,IDT;BS EN ISO 11608-4-2007,IDT;EN ISO 11608-4-2007,IDT;prEN ISO 11608-4-2007,IDT;NF S93-020-4-2007,IDT;S93-020-4PR,IDT;SN EN ISO 11608-4-2007,IDT;OENORM EN ISO 11608-4-2007,IDT;OENORM EN ISO 11608-4-2007

5Citation Network

5
Cite this standard
5
Referenced herein
Standards that cite ISO 11608-4:2006
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems Needle-based injection systems for medical use. Requirements and test methods. Needle-based injection systems Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes Requirements and test methods for medical pen injectors Part 5: Automatic functions (draft)
Referenced by ISO 11608-4:2006
IEC 60068-2-27:1987 IEC 60068-2-30:1980 IEC 60068-2-64:1993 IEC 60529:2001 ISO 11608-1:2000

6Frequently Asked Questions

What is ISO 11608-4:2006?
ISO 11608-4:2006 — Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors is an international standard developed by International Organization for Standardization (ISO). 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...
What does ISO 11608-4:2006 cover?
This standard covers: 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...
Who should use this standard?
This standard is intended for organizations, professionals, and stakeholders involved in various industries and sectors. It is applicable to manufacturers, service providers, regulatory bodies, and certification organizations.
What is the latest version of ISO 11608-4:2006?
The current published version is ISO 11608-4:2006, published on 2006-03. Always check for amendments or pending revisions.
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