Our certifications:
-
93/42/EEC Directive - Medical devices
"Oxygen generators for medical use, medical compressed air plants and medical vacuum plants."
-
EN ISO 13485:2003 - Medical devices
"Design, production and distribution of oxygen generators for medical use, medical compressed air plants and medical vacuum plants."
-
Free Sale - AFSSAPS
"Free sale certificate for exportation in the non-EC member States".
By the AFSSAPS (French Health Products Safety Agency).
-
ISO 9001:2000
"Design, production and distribution of oxygen generators, compressed air plants and vacuum plants for industrial use, distribution and after sales services of compressors, vacuum pumps and accessories for industrial use."
Common normative references:
-
NF S 90-140
"Medical air: admissible purity levels ."
(now replaced by the
European Pharmacopoeia).
-
NF S 90-155
"Non-inflammable medical gas pipeline system."
-
EN 737-2
"Medical gas pipeline systems - Part 2: anaesthetic gas scavenging disposal systems"
-
EN 737-3
"Medical gas pipeline systems - Part 3: pipelines for compressed medical gases and vacuum"
-
European Pharmacopoeia (EurPh)
- "Medicinal air" monograph (medical purpose compressed air).
-
HTM 2022
"Medical gas pipeline systems."
-
ISO 10083
"Oxygen concentrator supply systems for use with medical gas pipeline systems."
-
ISO 8573-1
"Compressed air - Part 1: contaminants and purity classes."
-
97/23/EEC Directive
"Equipment under pressure."
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Novair is organized with an
ISO 9001:2000 quality system
certified by SQS.
The Novair medical gas piping equipment, medical vacuum, medical air stations and oxygen generators are certified and marked
"CE medical device"
according to the
93/42/EEC Directive (annex II).
