BS ISO 28620:2010 Medical devices. Non-electrically driven portable infusion devices
BS ISO 28620 is an International Standard which 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.
BS ISO 28620 does not apply to:
- Electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24;
- Implantable devices;
- Enteral feeding pumps;
- Transdermal delivery devices;
- Devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).
Contents of BS ISO 28620:
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Components
4.2 Materials
4.3 Design and characteristics
4.4 Sterility and non-pyrogenicity
5 Operating requirements
5.1 Accuracy of the device
6 Test methods
6.1 General test conditions
6.2 Determination of the flow rate
6.3 Resistance to pressure
6.4 Drop test method
6.5 Water-tightness of the components of the device
6.6 Resistance to traction of the entire device
6.7 Bolus volume
6.8 Refill time
7 Information to be listed on packaging and/or product
8 Accompanying documents
Bibliography
