ISO 28620:2010
Medical devices - Non-electrically driven portable infusion devices
- Standard No.
- ISO 28620:2010
- Release Date
- 2010
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 28620:2020
- Latest
- ISO 28620:2020
- Scope
- This International Standard specifies essential requirements and related test methods for non-electrically driven portable infusion devices1). 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.
ISO 28620:2010 Referenced Document
- ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
- ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
- ISO 594-1 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment; Part 1 : General requirements
- ISO 594-2 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 28620:2010 history
- 2020 ISO 28620:2020 Medical devices — Non-electrically driven portable infusion devices
- 2010 ISO 28620:2010 Medical devices - Non-electrically driven portable infusion devices
