Hill-Rom Primo P02033, User Manual

Page: 44 / 398

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 11, 2012
Page 38 170924(2) - EN - Primo
™
User Manual
Regulatory requirements
The Primo
™
is a class IIa medical device that complies with the
requirements of Directive 93/42/EEC and its amendments.
The CE mark was applied in 1998.
The Primo
™
is designed and manufactured in accordance with the following
standards and classifications:
Quality standards:
Technical standards:
- ISO 9001 : 2008 - ISO 13485 : 2012 - ISO 14001 : 2004
Name P02033/P02034/P02044 P02047
EN IEC 60601-1: 2006 YES YES
EN IEC 60601-1-2: 2007 YES YES
EN IEC 60601-1-6: 2010 YES YES
EN IEC 60601-1-8: 2007 YES YES
EN IEC 60601-1-11: 2010 YES YES
EN ISO 14971: 2012 YES YES
EN ISO 10993-1: 2009 YES YES
EN ISO 10993-5: 2009 YES YES
EN ISO 10993-10: 2009 YES YES
EN ISO 15223-1: 2012 YES YES
EN 597-1: 1995 YES YES
EN 597-2: 1995 YES YES
SS 876 00 01 (NT FIRE 037) YES YES
UNI 9175: 2008 (Class 1 IM) NO YES
BS 6807: 2006, Clause 9, Ignition/5 NO YES
BS 7177: 1996 (Medium hazard) NO YES