Stryker 0940-000-000, Instructions For Use Manual

Page: 12 / 17

0940-001-025 Rev-L EN
www.stryker.com 11
Model: Stryker Cast Cutter (REF 0940-000-000) Stryker Cast Cutter (REF 0941-000-000)
European
Conformity:
Not applicable
Product Safety
Certification:
CSA International
Canadian Standards Association (CSA)
CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment
— Part 1: General Requirements for Safety
Underwriters Laboratories (UL)
UL 60601-1, Medical Electrical Equipment, Part 1: General
Requirements for Safety — First Edition ; Revisions through and
including April 26, 2006
Canadian Standards Association (CSA)
CAN/CSA-C22.2 No. 601.1-M90, Medical Electrical Equipment
— Part 1: General Requirements for Safety
Underwriters Laboratories (UL)
UL 60601-1, Medical Electrical Equipment, Part 1: General
Requirements for Safety — First Edition ; Revisions through and
including April 26, 2006
International Electrotechnical Commission (IEC)
IEC 60601-1:1988, Medical Electrical Equipment — Part 1:
General Requirements for Safety - Second Edition ; Amendment
1 (1991); Amendment 2 (1995); Corrigendum 1 (1995)
European Committee for Electrotechnical Standardization
(CENELEC)
EN 60601-1:1990, Medical Electrical Equipment — Part 1:
General Requirements for Safety ; Amendment 1 (1993);
Amendment 11 (1993); Amendment 12 (1993); Amendment 2
(1995); Amendment 13 (1996)
International Electrotechnical Commission (IEC)
IEC 60601-1:2005, Medical Electrical Equipment — Part
1: General Requirements for Basic Safety and Essential
Performance
; IEC Corrigendum 1 (2006); IEC Corrigendum 2
(2007)
IEC 60601-1:1988, Medical Electrical Equipment — Part 1:
General Requirements for Safety - Second Edition ; Amendment
1 (1991); Amendment 2 (1995); Corrigendum 1 (1995)
Canadian Standards Association (CSA)
CAN/CSA-C22.2 No. 60601-1:08, Medical Electrical Equipment
— Part 1: General Requirements for Basic Safety and Essential
Performance
American National Standards Institute (ANSI)/Association for
the Advancement of Medical Instrumentation (AAMI)
ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment —
Part 1: General Requirements for Basic Safety and Essential
Performance
; Consolidated Reprint (2009); Amendment 2
(2010)
European Committee for Electrotechnical Standardization
(CENELEC)
EN 60601-1:2006, Medical Electrical Equipment — Part
1: General Requirements for Basic Safety and Essential
Performance
; IEC Corrigendum 1 (2006); IEC Corrigendum 2
(2007); CENELEC Corrigendum (2010); CENELEC Amendment
A11 (2011)