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De Lama Sterilizzatori
Company
DELAMA

Standards

Since 1995 DE LAMA S.p.A. has been working in compliance with certified company’s quality management system, in accordance with ISO 9001 standards.
In 1999 DE LAMA S.p.A. got the European quality certification UNI CEI EN ISO 13489 relevant to medical devices.
DE LAMA S.p.A. achieved in 2002 the certification extention for ISO 9001:2000 “Vision 2000”.

In 2004 DE LAMA S.p.A. achieved the Total Quality Guarantee conforming to the H Module according to PED No. 97/23/CE for design and manufacturing of pressure equipments.
During 2006 DE LAMA S.p.A. got the extention/conformance of its Quality Management Systems according to UNI EN ISO 9001:2008 and UNI EN ISO 13485:2004 (medical devices) Standards and, at the same time, the EC certification according to the requirements set out in Annex II of EC Directive 93/42/CEE for the marking of the autoclaves for hospital use.

DE LAMA's pressure vessels can be designed, manufactured and tested even according to current pressure vessels codes in force in extra-EEC Countries.

 

Cisq
Icim
Ped
IQ Net
UDT CERT FDA
ASME
SVTI ASIT
ISPE GAMP
ML Cina
GMP
PCT