Medical devices. Non-electrically driven portable infusion devices

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