Quality assurance
In order to secure continuous improvement in its products and processes, Celitron Medical Technologies maintains a Quality Management System. In compliance with the international standards, the company measures, controls and analyzes all processes, and implements all necessary actions for achieving the required outputs.
We are committed to maintaining the effectiveness of our Quality Management system, both by complying with our Customer’s requirements to their full satisfaction and by responding to the various requirements derived from standards and laws (in particular, safety and performance regulations).
For this matter, the company identifies the training needs of all levels required by the personnel to perform their work. The company ensures that its employees receive appropriate training relevant for their position, and allocates resources to maintain and improve the products’ quality.
Celitron’s products comply with the following international standards and directive guidelines:
CE 2409 Approved by the Hungarian Notified Body CE Certiso Kft.
CE 1008 Approved by the Hungarian Notified Body TÜV Rheinland InterCert Kft.
General Applicable Directives:
Medical Device Directive (MDD) 93/42/EEC as amended (2007/47/EEC);
Pressure Equipment Directive – PED 97/23/EC;
Machinery Directive – 2006/42/EC;
2006/95/EC Low Voltage Equipment Directive;
EMC Directive 2004/108/EC Article 7 (1);
RoHS II Directive 2011/65/EU;
Standards:
EN 13060:2004 + A1:2009 + A2:2010 – Small steam sterilizers;
EN 285:2006 + A2:2009 – Large steam sterilizers;
ISO 17665-1:2006 – Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices;
EN 60601-1:2006 + AC:2010 – Medical electrical equipment – General requirements for safety;
EN/IEC 61010-1:2010 – Safety requirement for electrical equipment for measurement, control, and laboratory use – General requirements;
EN 61010-2-040:2005 – Safety requirements for electrical equipment for measurement, control and laboratory use – Particular requirements for sterilizers and washer-disinfectors used to treat medical materials;
EN 60601-1-2:2007+AC:2010 – Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests;
EN 61326:1997 + A1(98) + A2(01) + A3(03) minimum immunity requirements; Class A – Electrical equipment for measurement, control and laboratory use – EMC – requirements;
EN/IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices;
EN ISO 10993-1:2009 – Biological evaluation of medical devices – Evaluation and testing within a risk management process;
EN 1041:2008 – Information supplied by the manufacturer of medical devices;
EN ISO 15223-1:2012 – Medical devices – Symbols to be used with medical device labels, labelling and information to supplied – General requirements;
EN 60601-1-6:2010 – Medical electrical equipment – General requirements for basic safety and essential performance – Collateral standard: Usability;
47CFR part 15:2004, subpart B, Class A – Radio Frequency devices;
EN/IEC 60204-1:2005 + A1:2009 – Safety of machinery – Electrical equipment of machines – General requirements;
EN/IEC 61000-6-2:2005 – Electromagnetic compatibility (EMC) – Generic standards – Immunity for industrial environments;
EN/IEC 61000-6-4:2006 + A1:2011 – Electromagnetic compatibility (EMC) – Generic standards – Emission standard for industrial environments;
EN/IEC 61000-4-2:2008 – Electromagnetic compatibility (EMC) – Testing and measurement techniques – Electrostatic discharge immunity test;
Quality Management System Standards:
ISO 9001 – Quality Management Systems – Requirements;
ISO 13485 – Quality systems – Medical devices – Particular requirements for the application of ISO 9001;
EN ISO 14971:2012 – Risk Management for Medical device;