58
Appendix
Safety Compliance
UL 2601-1, Medical and Dental Equipment, 2
nd
edition
CAN/CSA-22.2 No. 601.1-M90 Medical Electrical Equipment, General Requirements for
Safety, 2
nd
edition
IEC 60601-1, Medical Electrical Equipment, General Requirements for Safety, 2
nd
edition.
IEC 60601-1-4, Safety for Programmable Electronic Systems, 1997
IEC 60529:2001, Degrees of Protection provided by Enclosures
ANSI/AAMI ES-1 1993, Safe current limits for Electromedical Apparatus
Applicable Particular Requirements
IEC 60601-2-2 Particular requirements for the safety of high frequency surgical
equipment, 1998
ANSI/AAMI HF 18:2001 Electrosurgical Devices
Electromagnetic Compliance
EN 55011:1998 Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment
Radio Disturbance Characteristics - Limits and Methods of Measurement CISPR
11:1997, Modified
IEC 60601-1-2:2001 Medical Electrical Equipment - Part 1-2: General Requirements for
Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
CISPR 11:1997, Industrial, scientific and medical (ISM) radio- frequency equipment –
Electromagnetic disturbance characteristics – Limits and methods of measurement
FCC 47 CFR Part 18 1998, Industrial, Scientific and Medical Equipment
To Previous Page