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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.
| Author | ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 1 |
| ICS | 11.040.20 : Transfusion, infusion and injection equipment
|
| Number of pages | 11 |
| Weight(kg.) | 0.1187 |
| Year | 2010 |
| Country | Switzerland |