dECLARATION Of CONfORMITy
Manufacturer:
Precision Medical, Inc.
300 Held Drive, Northampton, PA 18067, USA
coNTAcT: Quality Manager
Phone: 610-262-6090
Authorized european representative:
emergo europe
Molenstraat 15
2513 bH, The Hague
The Netherlands
Product:
Portable liquid oxygen System
Model(s):
PM2200 Model Series
MDD class:
IIb
classification criteria:
clause 3.1 rule 9 of Annex IX of MDD
As delivered, the object of the declaration described above is in conformity with the
requirements of MDD 93/42/eec Annex II.3, 99/36/ec and the following documents:
Document
Title
edition
94/55/ec Annex A & b ADr
2005
bS eN ISo 18777
Transportable liquid oxygen Systems for Medical Use - Particular requirements
2005
eN 1251-1
cryogenic vessels Part 1 Fundamental requirements: Marking &labeling testing.
2000
eN 1251-2
cryogenic vessels-transportable vacuum insulated vessels of not more than 1000 liters
volume-part 2:design,fabrication,inspectionand testing
2000
eN 1251-3
cryogenic vessels-transportable vacuum insulated vessels of not more than 1000 liters
volume-part 3:opertional requirements
2000
eN 13544-2
respiratory Therapy equipment - Part 2: Tubing And connectors
2002
eN 1418
Welding personnel - approval testing of welding operators for fusion welding and
resistance weld setters for fully mechanized and automatic welding of metallic materials
1998
bS eN ISo 15614-1 Specification and qualification of welding procedures for metallic materials - Welding
procedure test. Part 1
2004
93/42/eec
council Directive concerning Medical Devices
1993
ISo 18779
Medical Devices for conserving oxygen and oxygen Mixtures -
2005
Particular requirements
eN 14971
Medical Devices - Application of risk Management to Medical Devices
2000
eN 980
graphical Symbols for Use in the labeling of Medical Devices
2003
eN 1041
Information supplied by the Manufacturer with Medical Devices
1998
ISo 10993-1
biological evaluation of Medical Devices, Part 1
2003
ISo 10993-5
biological evaluation of Medical Devices, Part 5
1999
ISo 10993-10
biological evaluation of Medical Devices, Part 10
2002
Notified body for Product Safety:
TUv rheinland Products Safety gmbH
certification registration No’s: HD60002285, Sy60008447, 74_500_2415
Notified body for Pressure equipment: TUv rheinland Pressure equipment gmbH
certification registration No’s: 01 202 USA/.06 2888
There are no limitations on the validity of the declaration of conformity.
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