SpecificationCLV-180
1-8
ISSUE1
4. Canada Y
Canadian Medical Device and Equipment Regulation
Class: II
5. Singapore
Y
Singaporean medical device regulations
6. Other Y
K-FDA (Korea)
SDA (China)
Common to all
countries
IEC 60601-1 (Medical electrical equipment - Part 1: General requirements
for safety): 1988 + A1, A2
IEC 60601-1-1 (Medical electrical equipment - Part 1-1: General
requirements for safety): 2000
IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General
requirements for safety - Collateral standard: Electromagnetic compatibility
- requirements and tests): 2001
IEC 60601-2-18 (Medical electrical equipment - Part 2: Particular
requirements for the safety of endoscopic equipment): 1996 + A1
ISO 14971(Medical devices -- Risk management): 2000
ISO 9000-3(Software engineering -- Guidelines for the application of ISO
9001:2000 to computer software): 1997
ISO 8600-1(Optics and photonics -- Medical endoscopes and endotherapy
devices -- Part 1: General requirements): 1997
ISO 7000(Graphical symbols for use on equipment) : 2004
IEC 60417-1: 2002, -2: 1998(Graphical symbols for use on equipment)+
A1, A2
EU／EFTA
EN 980 (Graphical symbols for use on equipment): 2003
2. Japan JIS T1005 (Style manual for instruction manuals): 1983
JIS T0601-1 (Medical electrical equipment -- Part 1: General requirements
for safety): 1999
JIS T0601-1-1(Medical electrical equipment -- Part 1-1: General
requirements for safety -- Collateral standard: Safety requirements for
medical electrical systems): 1999
JIS T0601-1-2(Medical electrical equipment -- Part 1: General
requirements for safety -- 2. Collateral standard: Electromagnetic
compatibility -- Requirements and tests): 2002
3. USA UL 60601-1: 2003
4. Canada CAN/CSA-C22.2 No.601.1-M90: 1990
CAN/CSA-C22.2 No.601.1-S1: 1994
6. Applicable external regulations
5. Other Olympus Eco-Product Standard
Ambient temperature 10 – 40°C
Relative humidity: 30 – 85%
Air pressure 700 to 1060hPa
Usage environment Do not use in a combustible atmosphere
Type of protection against
electrical shocks
Class 1
Degree of protection: Type BF applied part
However, this instrument may be applied to the heart if it is used with equipment classified as
TYPE CF applied part. (indicated by the symbol)
Voltage 100 – 240 V AC
Frequency 50/60 Hz
Power fluctuation
Within ±10%
Frequency fluctuation
Within ±1 Hz
8. Other
1. Usage restrictions
Power consumption 500VA
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