CE CERTIFICATION CLASS 1 MEDICAL DEVICE – EUROPEAN
CE Marking on product is a Manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environment protection legislation.
EUROPEAN SAFETY CERTIFICATION EN71-1:2005
“SAFE FOR CHILDREN 0-3 YEARS”
This safety standard is the same that applies to toys intended for children between 0 and 3 years. The test includes tensile tests, torsion, fall, impact, compression and absence of small parts that can cause choking.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.