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| NEW! International Standard - ISO9919:2005 |
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This Standard is Entitled: Medical Electrical Equipment - Particular Requirements for the Basic Safety
and Essential Performance of Pulse Oximeter Equipment for Medical Use
Many manufacturers will claim that their products are “designed to comply” with ISO 9919:2005.
Nonin have not only designed products to comply, but have also fully TESTED all their Pulse Oximeter products and can state that Nonin Oximeters are “tested to comply”.
This is the new international standard, which for the first time, requires minimum ESSENTIAL
performance criteria, both clinical and environmental, to be achieved by Pulse Oximeters.
This new international standard has specific detailed requirements for a wide range of parameters then most important of which are listed below;
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1) Pulse Oximeter Accuracy - How accuracy is to be measured and expressed, especially where accuracy under specific conditions such as low perfusions and motion / vibration are claimed.
2) Basic Safety Features - Such as fire prevention, power failure modes, sharp edges,
identification, markings and instructions, limitation of temperature at sensor / skin interface to
prevent patient burns, abnormal operation / fault conditions.
3) Alarm Systems and Signal Inadequacy Indications - To ensure that alarms and signal quality are monitored correctly according to an agreed standard. This is vital for accurate results and patient security.
4) Electromagnetic Compatibility - To ensure that the device exceeds minimal levels of
electromagnetic compatibility.
5) Vibration, Mechanical and Noise Test - Shock and vibration testing and noise testing ensures basic levels of durability and transport worthiness.
6) Fluid Ingress to IPX2 - Pulse Oximeter equipment shall not cause a safety hazard and shall
function normally after under-going the aggressive new fluid ingress testing as detailed within
IEC 60529 for IPX2 or equivalent.
7) Cleaning, Sterilisation, Disinfection and Biocompatibility - Basic requirements to ensure a
minimum level of patient safety is maintained.
8) Full Detailed Definitions Of Accuracy Testing Systems, Accuracy Data Analysis and Accuracy Data Presentation - To ensure that clinicians may differentiate between different
product’s performance.
Nonin - Did You Know?
• Nonin have now sold more than one million Pulse Oximeters globally making them the largest supplier of Pulse Oximetry in the World.
• Nonin sell more Oximeters for military, emergency services, transport and extreme Environment use than any other company.
• Nonin Oximeters include PureLight® sensors and PureSAT® digital signal processing to ensure leading edge accuracy and dependability.
• Nonin offer the largest range of Pulse Oximeters for all applications - all tested to comply with ISO 9919:2005.
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Drop Testing |
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Fluid Ingress |
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Electromagentic Compatibility |
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Transportation |
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