ISO-28620 › Historical Revision Information
Medical Devices - Non-Electrically Driven Portable Infusion Devices
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ISO 28620:2010 specifies essential requirements and related test methods for non-electrically driven portable infusion devices. It applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application.
These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.
These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.
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Document Number
ISO 28620:2010
Revision Level
1ST EDITION
Status
Superseded
Publication Date
Feb. 15, 2010
Committee Number
ISO/TC 76