IEC 60601-1 3rd edition includes some changes compared to the previous edition. More importance is attached to this renewal in the risk management file and the process and basic performance in accordance with ISO 14971.
Some aspects of security and performance are defined according to collateral standards (number 60601-1-X). Revision dates may not be the same as the General Standard for Guarantees and Special Standards.
In addition to the IEC 60601-1, the general Safety standard for Medical Devices, we can assist you with product standards specific to section 2:
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
