Or. Admin. Code § 333-123-0065

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-123-0065 - Electrical Safety for Electronic Brachytherapy Devices

(1) A high voltage transformer shall:

(a) Be electrically isolated to prevent electrical and magnetic interference with the surrounding environment and ancillary equipment;

(b) Be isolated from personnel (e.g., operator) and the environment by a protective housing that can only be accessed through a cover requiring a tool for access or with electrical interlocks to prevent operation while open; and

(c) Have appropriate safety labels warning personnel of potential electrical shock and heat related injuries.

(2) Brachytherapy manufactured equipment shall be in compliance with the most current revision of the following International Electrotechnical Commission (IEC) documents:

(a) IEC 60601-1:1998+A1+A2:1995;

(b) IEC 60601-1-2:2001;

(c) IEC 60601-2-8:1999; and

(d) IEC 60601-2-17:2004.

Or. Admin. Code § 333-123-0065

PH 4-2013, f. & cert. ef. 1-29-13

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807