Safety and Regulatory Information
AA5348 | 2012-12-20 1–3
Product Safety Standards
The following Product Safety Standards apply to the CARESTREAM DRX-1 System
Detector and the DRX 2530 Detector, model DRX-2530-01.
USA UL 60601–1:2003—Medical Electrical Equipment
ANSI/AAMI ES60601–1:2005—Medical Electrical Equipment—Part 1: General
requirements for safety and essential performance
Canada CAN/CSA–C22.2 No. 601.1–M90 (R2005)—Medical Electrical Equipment
CAN/CSA–C22.2 No. 601.1S–94 (R1999)—Supplement No. 1–94 to CAN/
CSA–C22.2 No. 601.1–M90
CAN/CSA–C22.2 No. 601.1B-90 (R2006)—Amendment 2 to CAN/CSA–C22.2
No. 601.1–M90
CAN/CSA C22.2 No. 60601–1–08—Medical Electrical Equipment—Part 1:
General requirements for safety and essential performance
European
Union
EN 60601–1:1990 + Amendment 1:1993 + Amendment 2:1995—Medical
Electrical Equipment
EN 60601–1:2006—Medical Electrical Equipment—Part 1: General require-
ments for safety and essential performance
EN 60601–1–6:2010—Medical Electrical Equipment—Part 1: General require-
ments for safety and essential performance—Collateral Standard: Usability
Interna-
tional
IEC 60601–1:1988 + Amendment 1:1991 + Amendment 2:1995 —Medical
Electrical Equipment
IEC 60601–1:2005—Medical Electrical Equipment—Part 1: General require-
ments for safety and essential performance
IEC 60601–1–6:2010—Medical Electrical Equipment—Part 1: General require-
ments for safety and essential performance—Collateral Standard: Usability–3rd
edition
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