Quality system
Mitsar. Co. Ltd. quality management system is certified to be in compliance with the European standard for medical devices EN ISO 13485:2003.
Mitsar products have been classified as Class IIa devices and are in conformity with requirements of Annex I of the European Council Directive 93/42/EEC and are CE marked under the supervision of Notified Body VTT, Finland.
Certificates for download
Applied standards
- EN ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
- EN 60601-1:1990 (A1:1993/ A2:1995)- Medical electrical equipment - Part 1: General requirements for safety
- EN 60601-1-1:2001 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- EN 60601-1-2:2001 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- EN 60601-1-4:1996 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
- EN 60601-2-26:2003 - Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
- EN ISO 14971:2009 - Medical devices - Application of risk management to medical devices
- IEC 60601-1:1988 IEC 60601-1/Amd1:1991 IEC 60601-1/Amd2:1995 - Medical electrical equipment – Part 1: General requirements for safety
- IEC 60601-1-1:2000 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
- IEC 60601-1-2:2001 - Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4:1996 - Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
- IEC 60601-2-26:2002 - Medical electrical equipment – Part 2-26: Particular requirements for the safety of electroencephalographs
- ISO 14971:2007 - Medical devices - Application of risk management to medical devices