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Certificates

The obtained certificates are an inseparable part of our successful development and export to world markets. Beside the basic certificates EN ISO 9001:2000, EN ISO 13485:2003 (production quality system for medical technology) we obtained all necessary certificates for the production of pressure chambers of steam sterilizers for CZ, EU countries, Poland, Swiss etc. The ASME certificate entitles us to deliver pressure chambers to the USA as well. The steam sterilizers destined for the sale in the EU countries are certified by TÜV Cert. from Munich and are entitled to use the mark CE0123. Our devices comply with the requirements of appropriate standards and were tested successfully for the sale to many countries throughout the world.

  • certification of quality management system
  • certification of pressure vessel production

In order to meet the requirements of our customers and the legislation on the products delivered to the market in EU and other countries, we underwent the process of certification both of the quality management system and of the pressure vessel production.

   

ISO 9001:2000

01 - Certification of the Quality System

Certificate of the quality system according to ISO 9001:2015.
Guaranty of first-quality and effective quality management system.

ISO 9001:2000

02 - Environmental Management System Certificate

Environmental Management System Certificate according to the CSN EN ISO 14001:2016 standard.
Guarantee of Operations, Products and Services Environmental Impacts Management.

EN ISO 13485:2003

03 - Certification of the Quality System

Certificate of the quality system for medical devices according to EN ISO 13485:2016/AC:2012.
Guaranty of first-quality and effective quality management system.

CE 0123

04 - EC Certificate

Certification of the complete quality system for the purpose of proof of product validity according to MDD 93/42/EEC. Enables to attach the mark CE0123 on the medical technology devices.

ASME Code

05 - ASME Certificate

Certificate for the pressure vessel production according to ASME Code.

ASME Code

06 - Certificate of Steam Generators to ASME Code

Certificate for production of steam generators according to ASME Code.

NB Asme Code

07 - Authorization to Apply the "NB" Mark

Authorization to apply the "NB" mark for devices according to ASME Code.

Akreditace zkušební laboratoře

08 - Accreditation of the Test Laboratory

Accreditation of the test laboratory No. 1325 for tests of steam sterilizers and evaluation of the moist heat sterilization efficiency. Tests of hot air sterilizers and temperature technology devices.

Certifikát

09 - Certificate for Production of Pressure Devices

Certificate for the complex securing of production quality for pressure devices according to the module H/H1 Appendix 3 of the Directive No. 2014/68/EU issued by TÜV Süddeutschland Bau und Betrieb.

Certifikát - China

Certifikát - China

10 - Certificate for production of pressure vessels for China-export

Certificate of the quality system for the pressure vessel production according to the requirements of ASME and PED and for the steam generators according to the requirements of PED.