Conforming Safety Standards; Usa; Canada; Europe - Carestream DRX-Revolution Safety And Regulatory Information Manual

Safety and Regulatory Information
Conforming Safety
Standards

USA

Canada

Europe

International

1-10
UL 60601–1:2003 Medical Electrical Equipment, Part 1: General
Requirements for Safety
CAN/CSA–C22.2 No. 601.1–M90—Medical Electrical Equipment—Part 1:
General Requirements for Safety
EN 60601–1:1990 + A1+ A2—Medical Electrical Equipment—Part 1:
General Requirements for Safety
EN 60601–1–1:2001—Medical Electrical Equipment—Part 1–1: General
requirements for safety —Collateral standard: Safety requirements for
medical electrical systems
EN 60601–1–3:1994—Medical Electrical Equipment—Part 1–3: General
requirements for safety—3. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
EN 60601–1–4:1996 +A1—Medical Electrical Equipment—Part 1–4:
General requirements for safety—Collateral standard: Programmable
electrical medical systems
EN 606011–6:2004—Medical Electrical Equipment—Part 1–6: General
requirements for safety—Collateral standard: Usability
EN 60601–2–32:1994—Medical Electrical Equipment—Part 2–32:
Particular requirements for the safety of associated equipment of X-ray
equipment
IEC 60601–1:1988 + A1 + A2—Medical Electrical Equipment—Part 1:
General Requirements for Safety
IEC 60601–1–1:2000—Medical Electrical Equipment—Part 1–1: General
requirements for safety—Collateral standard: Safety requirements for
medical electrical systems
IEC 60601–1–3:1994—Medical Electrical Equipment—Part 1–3: General
requirements for safety —3. Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment
IEC 60601-1-4:1996 +A1—Medical Electrical Equipment—Part 1–4:
General requirements for safety—Collateral standard: Programmable
electrical medical systems
IEC 60601-1-6:2004 - Medical Electrical
requirements for safety—Collateral standard: Usability
IEC 60601–2–32:1994—Medical Electrical Equipment—Part 2-32:
Particular requirements for the safety of associated equipment of X-ray
equipment
9J0239
quipment—Part 1–6: General
E