90
OxyMag_rev26
14.
Technical Specification
14.1
Classification
•
NBR
–
IEC
–
60601
Class II Equipment, energized internally, BF-type for continuous operation. Protected against the ingress of solid foreign objects
> 2.5 mm or bigger and splash-proof equipment - IP34.
•
RDC 185/01
–
Classification Rule 11
Class III
–
All active medical devices intended to administer medicines, body fluids or other body substances or to extract them
from this, fall under Class II, unless this is done in a potentially hazardous way, given the nature of the substances, body part
involved and mode of application, in this case, then they fall under Class III.
14.2
Standards
•
ISO 10651-3
–
Lung Ventilators for Use Medical Part 3: Particular Requirements for Emergency and Transport Ventilators
•
ISO 5356-1
–
Anesthetic and respiratory equipment
–
Conical connectors
–
Part1: Cones and sockets
•
ABNT NBR 11906
–
Conexões roscadas e de engate rápido para postos de utilização dos sistemas centralizados de gases
de uso medicinal sob baixa pressão
•
IEC 60601-1 Ed. 3.0 (2005) + Amd. 1 (2012) (EN 60601-1:2006 + A1: 2013)
- Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
•
EN 794-3:1998+A2:2009
- Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
•
EN 1789:2007+A1:2010
- Medical vehicles and their equipment - Road ambulances
•
ISO 5359:2008/Amd 1:2011 (EN ISO 5359:2008+A1:2011)
- Low-pressure hose assemblies for use with medical gases
•
IEC 60601-1-2 Ed. 3.0 (2007) (EN 60601-1-2:2007) -
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
•
IEC 62304:2006 +AMD1:2015 (EN 62304:2006/2008)
-
Medical device software - Software life cycle processes
•
IEC 60601-1-8 Ed. 2.0 (2006)/A1:2012 (EN 60601-1-8:2007/A11:2017) -
Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems
•
IEC 60601-1-4: 1996/A1:1999 (EN 60601-1-4: 1996/A1: 1999)
- Medical electrical equipment - Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical systems
•
IEC 60601-1-6:2010 (EN 60601-1-6:2010) -
Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
•
IEC 62366:2007 (EN 62366:2008)
- Medical devices - Application of usability engineering to medical devices
•
EN ISO 17665-1:2006
- Sterilization of health care products - Moist heat - Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices