BS EN 60601-2-39:2008 - Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment – BSI British Standards

BS EN 60601-2-39:2008

Medical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Status : Current, Under review   Published : March 2009

Format
PDF

Format
HARDCOPY



BS EN 60601-2-39 is the international standard that applies to the basic safety and essential performance of peritoneal dialysis medical electrical (ME) equipment, referred to here as PD equipment.

BS EN 60601-2-39 applies to PD equipment intended for use either by medical staff or under the supervision of medical experts, including PD equipment operated by the patient, regardless of whether the PD equipment is used in a hospital or domestic environment.

This standard can also be applied to PD equipment used for compensation or alleviation of disease, injury or disability.

These particular requirements do not apply to the dialysing solution, or the dialysing solution circuit.

Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned.

Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.

Contents of BS EN 60601-2-39 contain:

  • Foreword
  • Scope, object and related standards
  • Normative references
  • Terms and definitions
  • General requirements
  • General requirements for testing of PD equipment
  • Classification of ME equipment and ME systems
  • PD equipment identification, marking and documents
  • Protection against electrical hazards from PD equipment
  • Protection against mechanical hazards of ME equipment and ME systems
  • Protection against unwanted and excessive radiation hazards
  • Protection against excessive temperatures and other hazards
  • Accuracy of controls and instruments and protection against hazardous
  • Outputs
  • Hazardous situations and fault conditions
  • Programmable electrical medical systems (PEMS)
  • Construction of ME equipment
  • ME systems
  • Electromagnetic compatibility of ME equipment and ME systems
  • Electromagnetic compatibility – requirements and tests
  • General requirements for radiation protection in diagnostic x-ray equipment
  • Usability
  • General requirements, tests and guidance for alarm systems in medical electrical equipment
  • and medical electrical systems
  • Requirements for the reduction of environmental impacts
  • Process requirements for the development of physiologic closed-loop
  • Controllers
  • Protection against hazards of ignition of flammable anaesthetic
  • Mixtures
  • Particular guidance and rationale
  • Index of defined terms used in this particular standard

BS EN 60601-2-39:2008 replaces BS EN 60601-2-39:1999, BS 5724-2.39:1999,IEC 60601-2-39:1999 Medical electrical equipment. Particular requirements for safety. Particular requirements for safety. Specification for peritoneal dialysis equipment which has been withdrawn.




Standard NumberBS EN 60601-2-39:2008
TitleMedical electrical equipment. Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
StatusCurrent, Under review
Publication Date31 March 2009
Normative References(Required to achieve compliance to this standard)EN 60601-1, IEC 60601-1-9:2007, EN 60601-1-9:2008, IEC 60601-1-10:2007, EN 60601-1-10:2008
Informative References(Provided for Information)93/42/EEC
International RelationshipsEN 50393:2006,EN 60601-2-39:2008,IEC 60601-2-39:2007
DescriptorsTemperature control, Safety engineering, Leakage currents, Liquids, Testing conditions, Artificial kidneys, Equipment safety, Instructions for use, Pumps, Leak tests, Current measurement, Electrical safety, Medical equipment, Pressure, Electrical medical equipment, Electric shocks, Technical documents, Electronic equipment and components, Electrical equipment, Dialysis, Safety measures
ICS11.040.99
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
CommitteeCH/150/2
ISBN978 0 580 56986 9
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size416 KB
Price£214.00


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