Declaration of conformity – Precision Trading PM5200 User Manual
Page 16
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:
Gas mixers for medical Use
model(s):
Pm5200EN, Pm5200mEN, Pm5300EN, Pm5300mEN
mDD Class:
IIb
Classification criteria:
Clause 3.1 Rule 11 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 and the following documents:
Document
Title
Edition
ISO 14971
medical Devices - Application of Risk management 2000+A1:2003
to medical Devices
EN 980
Graphical Symbols for Use in the Labeling of medical
2003
Devices
EN 1041
Information supplied by the manufacturer with medical
1998
Devices
ISO 11195
Gas mixers for medical use - stand alone gas mixers
1995
ISO 15001
Anesthetic and respiratory equipment -- Compatibility
2004
with oxygen
Notified Body:
TÜV Rheinland Products Safety GmbH
EC Certificate No.: HD600119110 0001
www.precisionmedical.com
ISO 13485 Certified
504745 Rev8 (E) 03/18/08 (?m) Printed in USA