Draft Standards Archives
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Biomedical Equipment
Electromedical Equipment
AAMI Recommended Practice/ American National Standard
AAMI/CDV-1 EC57, Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. See
more information
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EC57-D |
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EC57-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-1 EC53, ECG trunk cables and patient leadwires. See
more information
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EC53-D |
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EC53-D-PDF |
$0/$25 |
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Implants and Artificial Organs
International Standard
ISO/DIS-1 14708-07, Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems. See
more information
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1470807-D |
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1470807-D-PDF |
$0/$25 |
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Sterilization
AAMI/ American National Standard
AAMI/CDV-1 13408-01:2008/A1, Aseptic processing of health care products - Part 1: General requirements, Amendment 1. See more information
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1340801-D |
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1340801-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-1 ST15883-01:2009/A2, Washer-disinfectors - Part 1: General requirements, terms and definitions and tests, Amendment 2. See more information
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1588301-AD |
free |
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1588301-AD-PDF |
free |
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AAMI/ American National Standard
AAMI/CDV-1 ST77, Containment devices for reusable medical device sterilization. See more information
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ST77-D |
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ST77-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-2 11135, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. See more information
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11135-D |
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11135-D-PDF |
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International Standard
ISO/DIS-1 11135, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. See more information
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11135-D |
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11135-D-PDF |
$0/$25 |
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International Standard
ISO/DIS-1 13408-01:2008/A1, Aseptic processing of health care products - Part 1: General requirements, Amendment 1. See more information
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1340801-D |
$20/$25 |
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1340801-D-PDF |
$0/$25 |
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Syringes and Needles
International Standard
ISO/DIS-1 10555-01, Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements. See more information
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1055501-D |
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1055501-D-PDF |
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International Standard
ISO/DIS-1 10555-03, Sterile, single-use intravascular catheters -- Part 3: Central venous catheters. See more information
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1055503-D |
$20/$25 |
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1055503-D-PDF |
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International Standard
ISO/DIS-1 10555-04, Intravascular catheters -- Sterile and single-use catheters - Part 4: Balloon dilatation catheters. See more information
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1055504-D |
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1055504-D-PDF |
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International Standard
ISO/DIS-1 10555-05, Sterile single use intravascular catheters - Part 5: Over-the-needle peripheral intravascular catheters. See more information
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1055505-D |
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1055505-D-PDF |
$0/$25 |
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