ECGMAC EM-301 - Dimension and Weight; Environment Conditions

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C.2 Dimension and weight
Dimension 310mm×244mm×65mm
Package Size 380 mm×330 mm×230mm
Net weight 2.25KGS
Gross weight 4.1KGS
C.3 Environment conditions
z Transportation
Temperature -20℃～+50℃
Relative humidity 25%～95% (Non-condensing）
Atmospheric pressure 500hPa～1060hPa
z Storage
Temperature -20℃～+50℃
Relative humidity 25%～85%
Atmospheric pressure 500hPa～1060hPa
z Usage
Temperature +5℃～+40℃
Relative humidity 25%-80%
Atmospheric pressure 700hPa～1060hPa
Appendix D Applied standards
1 EN 980:2008 Symbols for use in the labeling of medical devices
2 EN 1041:2008 Information supplied by the manufacturer of medical devices
3 EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation
and testing (ISO 10993-1:2003)

4 EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity (ISO 10993-5:2009)

5 EN ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for
irritation and delayed-type hypersensitivity (ISO
10993-10:2002, including Amd 1:2006)
6 EN ISO 13485:2003/AC2007 Medical devices - Quality management systems - Requirements
for regulatory purposes (ISO 13485:2003)
7 EN ISO 14971:2007 Medical devices - Application of risk management to medical
devices (ISO 14971:2007)
8 EN
60601-1:1990+A1:1993+A2:1995
Medical electrical equipment -- Part 1: General requirements
for safety IEC 60601-1:1988 +A1:1991+A2:1995
9 EN60601-1:2006 Medical electrical equipment --Part1: General requirements for
basic safety and essential performance IEC 60601-1:2005
10 EN 60601-1-2:2001+A1:2006 Medical electrical equipment -- Part 1-2: General requirements
for safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests