Our certificates

​CE/EC Certificate​

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

 

Certification EN ISO 13485:2019
Certification EN ISO 13485:2012

Declaration of conformity

document stating that a product meets the standards to which it must legally adhere, such as safety regulations

 

Declaration of conformity AHA Flex

List of applied standards:

IEC 60601-1-2:2014
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

EN 980:2014
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

EN 14931
Pressure vessels for human occupancy (PVHO) – Multi-place pressure chamber systems for hyperbaric therapy – Performance, safety requirements and testing

We’re reaching new dimensions in hyperbaric medicine.

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