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Certificates

certifikátyThe 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.

 

01 - Certification of the quality system

ISO 9001:2000Certificate of the quality system according to ISO 9001:2008.
Guaranty of first-quality and effective quality management system.

 

 

 

 

 

 

02 - Environmental Management System Certificate

ISO 9001:2000Environmental Management System Certificate according to the CSN EN ISO 14001:2016 standard.
Guarantee of Operations, Products and Services Environmental Impacts Management.

 

 

 

 

 

 

03 - Certification of the quality system

EN ISO 13485:2003Certificate of the quality system for medical devices according to EN ISO 13485:2012/AC:2012.
Guaranty of first-quality and effective quality management system.

 

 

 

 

 

EN ISO 13485:2003Certificate of the quality system for medical devices according to EN ISO 13485:2003/AC:2007 in Canada.

 

 

 

 

 

 

04 - EC certificate

CE 0123Certification 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.

 

 

 

 

 

 

05 - ASME certificate

ASME CodeCertificate for the pressure vessel production according to ASME Code.

 

 

 

 

 

 

 

06 - Certificate of steam generators to ASME Code

ASME CodeCertificate for production of steam generators according to ASME Code.

 

 

 

 

 

 

 

07 - Authorization to apply the "NB" mark

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

 

 

 

 

 

 

 

08 - Accreditation of the test laboratory

Akreditace zkušební laboratořeAccreditation 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.

 

 

 

 

 

 

 

09 - Certificate for production of pressure devices

CertifikátCertificate 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.

 

 

 

 

 

 

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

Certificate - ChinaCertificate 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.

 

 

 

 

 

 

Certificate - China