Quality Assurance

Celitron Medical Technologies has established, implements, documents and maintains a Quality Management System in order to achieve continuous improvements in products and in processes, in compliance with international standards. The company controls, measures and analyzes all processes and implements any action for achieving the required outputs.

We are committed to maintain 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 (and 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 0473 Approved by the British Notified body Intertek- AMTAC.
  • EN 13060 - Small Steam Sterilizers;
  • EN 285 - Large Steam Sterilizers;
  • Medical Device Directive (MDD) 93/42/EEC;
  • Pressure Equipment Directive (PED) 97/23/EC;
  • ISO 17665-1: 2006.

Safety and EMC Standards:

  • EN 60601-1 + A1:93 + A2:95- Medical Electrical Equipment- General Requirements for Safety;
  • EN 61010-1 – Safety Electrical Equipment for Laboratory Use;
  • EN 61010-2-040:05 - Safety requirements for electrical equipment for measurement, control and laboratory use- Particular requirements for sterilizers and washer-disinfectors used to treat medical materials;
  • EN 60601-1-2:01 – Medical electrical equipment- General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests (EMC);
  • EN 61326: 1997 + A1:98 + A2:01+ A3:03 Electrical equipment for measurement, control and laboratory use- EMC- requirements;
  • EMC Directive 89/336/EEC Article 7 (1).

Quality Management System Standards:

  • ISO 9001: 2008- Quality Management Systems- Requirements;
  • ISO 13485: 2003- Medical devices – Quality management systems- Requirements for regulatory purposes;
  • EN ISO 14971 – Risk Management for Medical device.

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