Safety and quality
Responsibility
As a manufacturer of medical products we manufacture our care cots for children in accordance with the requirements of the European regulations for the safety of medical products (EU) 2017/745
We have very high demands when it comes to the saftey and quality of our care cots for children. We
- avoid clamping and trapping points
- only use materials harmless to the human health and the environment
- only use non-flammable materials
- produce the lacquered wooden surfaces with hygienic properties that are absolutely harmless to health
- ensure that children's beds are used in a way that is not harmful to health
This demand and our quality management system - introduced in 2007 - guarantee safe and easy to use care cots for children which are of the highest quality.
Requirements towards medical products
- DIN EN 50637 Medical electric devices
Specific regulation for the safety of medical beds for children inlcuding the main characteristics - DIN EN 60601-2-52 Medical electric devices
Specific regulation for the safety of medical beds for children inlcuding the main characteristics - DIN EN 60601-1 Medical electric devices
Part 1 General regulation for safety - DIN EN 60601-1-11 Regulation for medical electric devices and medical electric systems for the medical home care
The compliance with these regulations is being supervised, tested and certified by Eurofins Product Service GmbH as accredited testing laboratory for national and international markets
High quality standards
Surfaces
- DIN 68861, 1B Furniture surfaces
Part 1: Behaviour to chemical substances - DIN EN 71 Part 3 Safety of toys
- EN ISO 10993-1 Biological evaluation of medical devices
Quality management
- DIN EN 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
- DIN EN 9001 Quality management systems - requirements
- DIN EN 14001 Environmental management systems - requirements