BS ISO 28620:2010 - Medical devices. Non-electrically driven portable infusion devices – BSI British Standards

BS ISO 28620:2010

Medical devices. Non-electrically driven portable infusion devices

Status : Superseded, Withdrawn   Published : March 2010 Replaced By : BS ISO 28620:2020

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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

 




Standard NumberBS ISO 28620:2010
TitleMedical devices. Non-electrically driven portable infusion devices
StatusSuperseded, Withdrawn
Publication Date31 March 2010
Withdrawn Date20 January 2020
Normative References(Required to achieve compliance to this standard)ISO 10993, ISO 594-2, ISO 594-1, ISO 15223-1
Informative References(Provided for Information)2008/128/EC, EN 1041, ISO 554, IEC 60601-2-24, EN 13868, ISO 11135-1, ANSI/AAMI ST67:2003, ISO 11137, ISO 10555-1, EN 556-1, ISO 14937, ISO 11607-1, ISO 17665-1, BS EN ISO 80369-1:2018, ISO 80369-1:2018
Replaced ByBS ISO 28620:2020
International RelationshipsISO 28620:2010
Draft Superseded By08/30170025 DC
DescriptorsPortable, Drug administration, Liquids, Pumps, Parenteral infusion equipment, Product information, Medical equipment, Conical fittings (syringes), Instructions for use, Performance testing, Containers, Tubing (medical), Performance
ICS11.040.20
Title in FrenchDispositifs médicaux. Diffuseurs portables de médicaments, non mus électriquement
Title in GermanMedizinprodukte. Tragbare Infusionspumpen
CommitteeCH/212
ISBN978 0 580 60002 9
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size305 KB
Price£130.00


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