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Mission-Critical Medical

  Product Format Price Order   Ships In...  
1. ISO 11607:2003 More Info
01-Feb-2003
Packaging for terminally sterilized medical devices - International Restrictions
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2. ANSI/AAMI/ISO 13485:2003 More Info
18-Jun-2003
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
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Printed Edition $95.00 Buy H 24-48 Hours
PDF $95.00 Buy PDF Download

3. ANSI/AAMI/ISO 14791:2000/A1:2003 More Info
26-Aug-2003 REPLACED by ANSI/AAMI/ISO 14971:2007
Medical Devices - Application of Risk Management to Medical Devices
 
Printed Edition $90.00 Buy H 24-48 Hours
PDF $90.00 Buy PDF Download

4. ANSI/AAMI/ISO 15223:2000 + Amendments 1 and 2 More Info
REPLACED by ANSI/AAMI/ISO 15223-1:2007
Medical devices-Symbols to be used with medical device labels, labeling,and information to be supplied.
 
Printed Edition $70.00 Buy H 24-48 Hours
PDF $70.00 Buy PDF Download

5. ISO/IEC 17025:2005 More Info
15-May-2005
General requirements for the competence of testing and calibration laboratories
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6. BS EN 980:2003 More Info
13-Aug-2003 REPLACED by BS EN 980:2008
Graphical symbols for use in the labelling of medical devices
 
Printed Edition $224.58 Buy H 24-48 Hours

7. BS EN 1041:1998 More Info
15-Jul-1998
Information supplied by the manufacturer with medical devices
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Printed Edition $157.60 Buy H 24-48 Hours

8. NEMA PS3 (Set) More Info
01-Dec-2004 REPLACED by NEMA PS3 (Set)
Digital Imaging and Communications in Medicine (DICOM) Set
 
Printed Edition $945.00 Buy H 24-48 Hours

9. IEC 60601-1 Ed. 3.0 b:2005 More Info
15-Dec-2005
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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10. IEC 60601-1-1 Ed. 2.0 b:2000 More Info
14-Dec-2000
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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11. AAMI TIR 12-94 More Info
24-Nov-1994 REPLACED by AAMI TIR12:2004
Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Manufacturers
 
Printed Edition $100.00 Buy H 24-48 Hours
PDF $100.00 Buy PDF Download