SS IEC 60601-2-39:2018
Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
OVERVIEW
Applies to the basic safety and essential performance of peritoneal dialysis ME equipment, hereafter referred to as PD equipment. 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.
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.
COMMENTS
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PRODUCT DETAILS
Status | Current |
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Edition | 2018 |
No. of Pages | 32 |
ICS Classification | 11.040.99 Other medical equipment |
Committee | Biomedical and Health Standards Committee |
Available for Purchase | Global |
Adoption | IEC 60601-2-39 : 2018 IDT |