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
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