BS EN 1837:1999+A1:2009 Safety of machinery. Integral lighting of machines
BS EN 1837 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 EN 1837 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 EN 1837:
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
EN 1837:1999+A1:2009