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.
