Regulatory Requirements - Hill-Rom Primo P02033 Manuel D'utilisation

PROPRIETARY AND CONFIDENTIAL DRAFT: octobre 11, 2012

Regulatory requirements

The Primo
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:
- ISO 9001 : 2008
Technical standards:
EN IEC 60601-1: 2006
EN IEC 60601-1-2: 2007
EN IEC 60601-1-6: 2010
EN IEC 60601-1-8: 2007
EN IEC 60601-1-11: 2010
EN ISO 14971: 2012
EN ISO 10993-1: 2009
EN ISO 10993-5: 2009
EN ISO 10993-10: 2009
EN ISO 15223-1: 2012
EN 597-1: 1995
EN 597-2: 1995
SS 876 00 01 (NT FIRE 037)
UNI 9175: 2008 (Class 1 IM)
BS 6807: 2006, Clause 9, Ignition/5
BS 7177: 1996 (Medium hazard)
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is a class IIa medical device that complies with the
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- ISO 13485 : 2012
Name P02033/P02034/P02044
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
NO
NO
NO
170924(2) - EN - Primo
- ISO 14001 : 2004
P02047
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
YES
User Manual
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