BresoTEC URU User Manual - Page 4

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Environmental conditions
of transportation and
storage before first use
Environmental conditions
of transportation and
storage between uses
Safety and EMC Compliance
1.
IEC 60601-1:2005+AMD1:2012 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
2.
IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests
3.
IEC 60601-1-6:2010+AMD1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
4.
IEC 60601-1-11:2015: Medical electrical equipment - Part 1-11: General requirements
for basic safety and essential performance - Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
5.
IEC 62366-1:2015: Medical devices -- Part 1: Application of usability engineering to
medical devices
6.
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid
electrolytes -Safety requirements for portable sealed secondary lithium cells, and for batteries
made from them, for use in portable applications - Part 2: Lithium systems
7.
ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and
testing within a risk management process
8.
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro
cytotoxicity
9.
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for
irritation and skin sensitization
BresoTec Inc. | 555 Richmond St. W, Unit 407
Toronto, ON, M5V 3B1 Canada
www.bresotec.com
User Guide for User Recording Unit (URU)
Relative Humidity
Atmospheric Pressure
Temperature
10% - 100%, including
condensation
50 - 106 kPa
-25°C without relative
humidity control; and
+70°C at a relative
humidity up to 93%, non-
condensing
DOC-00015
Rev.00