UNI EN ISO 13485:2012

UNI EN ISO 13485:2012 and EC labelling

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UNI EN ISO 13485:2012

SIAD is certified in compliance with UNI EN ISO 13485:2012 and UNI EN ISO 9001 for.

  • technical assistance and maintenance of pipelines for medical gas distribution and for vacuum and of anaesthetic gas scavenging disposal systems; sale of components for pipelines;
  • design, production, sale and distribution of carbon dioxide medical device for laparoscopy, thoracoscopy and cryotherapy surgery and of cryogenic gases medical devices for cryotherapy and cryopreservation.

ISO 13485:2012 Certificate

ISO 9001:2015 Certificate


The Approval Certificate for EC labelling of nitrogen for cryopreservation and cryotherapy (14737) certifies that the Quality Control System is in conformity with the requirements of the Regulation 93/42 EC Attachment II.

Certificate 14737/1

The Approval Certificate for the EC labelling of carbon dioxide for laparoscopy and thoracoscopy (14738) certifies that the Quality Control System is in conformity with the requirements of the Regulation 93/42 EC Attachment II.

In occasion of the renewal on 15/10/2015 the EC labelling has benn extended to the application of carbon dioxide for cryotherapy surgery.

Certificate 14738/1