Ensuring safety, quality and trust
Ensuring safety, quality and trust
Regulatory compliance is essential to the health and safety industries. mSafety has certifications to help you stay transparent and compliant.
As a solution designed for medical use, we’ve certified that mSafety does not pose a risk to patients, operators or surrounding equipment. This includes the safety of all people involved, the electromagnetic compatibility with other devices and suitability for a home healthcare environment.
IEC 60601-1-1: Safety
IEC 60601-1-2: EMC
IEC 60601-1-11: Home healthcare environment
mSafety devices are designed so that everyone can use them, including those with sensitive skin. We have certifications that demonstrate that the devices do not damage the skin, irritate the skin or sensitise the skin.
ISO10993-5: Cytotoxicity Test
ISO10993-10: Skin Irritation Test
ISO10993-10: Skin Sensitisation Study (Maximisation test)
Sony Network Communications Europe, the supplier of mSafety, has ISO 14001 certification which demonstrates responsible environmental management during the entire product lifecycle.
mSafety devices are produced by Sony; material procurement and ethical sourcing follow strict standards outlined in Sony's "Green Partner Environmental Quality Approval System".
Sony is a founding member of Responsible Business Alliance (RBA), and follows their detailed Code of Conduct to secure human rights, ethical business and environmental protection.
mSafety is a solution designed to be used internationally, and has country-specific electronic certifications to make this possible.
For instance, in the U.S., mSafety fulfils essential FCC standards for equipment (FCC 15B, FCC 15C, FCC 27 and FCC 90).
You can download the complete list of countries and standards at the bottom of this page.
To simplify the integration of mSafety for our customers around the world, we aim to provide the most comprehensive certification coverage that we can. That’s why we are continuously working on expanding our list of certifications. For instance, we are in the process of certifying mSafety according to the ISO 13485 standard.
Please don’t hesitate to contact us if your organisation has questions regarding additional certifications necessary in your industry.
mSafety regulatory compliance (PDF)
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