demonstrates that the manufacturer complies with the Medical Device Directive 93/42/EEC, that regulate the area of medical devices.
EN ISO 13485:2016
standard applied by the manufacturers of medical devices to prove the compliance of the quality system with the requirements of MDD 93/42/EEC
Declaration of conformity
document stating that a product meets the standards to which it must legally adhere, such as safety regulations
List of applied standards:
Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
EN 60601-1:2006 + A1:2013 + A12:2014
Medical electrical equipment. General requirements for basic safety and essential performance
EN ISO 80601-2-69:2014
Medical electrical equipment, Part 2: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
EN 60601-1-6:2010 + A1:2015
Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
IEC 62366:2007 + A1:2014
Standard | Amendment 1 – Medical devices – Application of usability engineering to medical devices.
EN ISO 14971:2012
Medical devices. Application of risk management to medical devices
European standard for symbols used by medical device manufacturers.
EN ISO 10993-5:2009-10
Biological evaluation of medical devices. Tests for in vitro cytotoxicity.
EN ISO 10993-10:2013
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing