Textile Safety Certification - Oekotex 100 Class
Oekotex is a certification that guarantees the absence of harmful chemical in textiles. All materials that make up the pillow including the label and thread to sew the different parts are certified Oecotex 100 class 1 for babies, the strictest of all.
Mimos Pillow is proven in clinical studies in Sweden
Shown very effective in correcting a plagiocephaly. Together with physiotherapy Mimos pillow is the complement when the baby have to be on the back.
Airflow Safety - Anti-suffocation TUV Certification
Certification authority “TUV Rheinland” has devised a rule and the appropriate test to assess the risk of suffocation of mattresses and pillows for infants. This standard specifies the minimum amount of air to flow through a textile material to ensure breathing if a child is trapped against it. Mimos pillow has been tested and conforms to this safety standard.
“TUV Rheinland” is the largest certification body in the world on safety issues. ey certify in the fields of energy, food, transport and health (www.tuv.com)
European Safety Certification EN 71-1 "Safe for Children 0-3 Years"
Mimos Pillow complies with european standard EN 71-1: 2005. This safety standard is the same that applies to toys intended for children between 0 and 3 years. e tests include tensile tests, torsion, fall, impact, compression and absence of small parts that can cause choking. This certification guarantees the safety of Mimos pillow for use with children between 0 and 3 years old.
CO2 - Re-breathing Safe
Certified lab tests have proven that Mimos Pillow does not pose a risk of Carbon dioxide rebreathing. Mimos pillow has been tested in laboratory and pass the certification of C02 re-breathing safe. This means that the pillow is not risking the baby the re-breath his own CO2.
Quality Requirements for Medical Devices
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life
Biocompatibility Tests According to ISO 10993
The tests of cytotoxicity, sensitization and irritation of the skin for medical devices have made it possible to certify that the cushion Mimos® is not toxic for the human organism or causes skin sensitization or irritation.