Draft Standards Archives
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Biological Evaluation
AAMI/ American National Standard
AAMI/CDV-1 13022 (ISO/TC 194/SC 1 N113), Tissue product safety - Application of risk management to viable materials of human origin used for the production of medical products. See
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13022-D |
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13022-D-PDF |
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International Standard
ISO/CD-V-1 13022 (ISO/TC 194/SC 1 N113), Tissue product safety - Application of risk management to viable materials of human origin used for the production of medical products. See
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13022-D |
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13022-D-PDF |
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Dialysis Equipment
AAMI/ American National Standard
AAMI/CDV-1 8637 (ISO/DIS 8637), Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. See
more information
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8637-D |
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8637-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-1 8638 (ISO/DIS 8638), Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters. See
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8638-D |
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8638-D-PDF |
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International Standard
ISO/DIS-1 13960, Cardiovascular implants and artificial organs - Plasmafilters. See
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13960-D |
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13960-D-PDF |
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International Standard
ISO/DIS-1 8637, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. See
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8637-D |
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8637-D-PDF |
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International Standard
ISO/DIS-1 8638, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters. See
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8638-D |
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8638-D-PDF |
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Electromedical Equipment
AAMI/ American National Standard
AAMI/CDV-1 60601-2-04 (IEC 62D/748/CDV), Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators. See
more information
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601204-D |
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601204-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-1 60601-2-25 (IEC 62D/758/CDV), Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. See
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601225-D |
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601225-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-1 60601-2-27 (IEC 62D/745/CDV), Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.
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601227-D |
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601227-D-PDF |
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International Standard
IEC/CD-1 80601-2-13 (IEC 62D/750/CD), Medical electrical equipment - Part 2-13: Particular requirements for the basic safety and essential performance of an anaesthetic workstation. See
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801213-D |
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801213-D-PDF |
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International Standard
IEC/CD-1 80601-2-55 (IEC 62D/746/CD), Medical electrical equipment - Part 2-55: Particular requirements for basic safety and essential performance of respiratory gas monitors. See
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601255-D |
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601255-D-PDF |
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International Standard
IEC/CD-1 80601-2-60 (IEC 62D/739/CD), Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment. See
more information
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801260-D |
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801260-D-PDF |
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International Standard
IEC/CDV-1 60601-2-04 (IEC 62D/748/CDV), Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators. See
more information
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601204-D |
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601204-D-PDF |
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International Standard
IEC/CDV-1 60601-2-23 (IEC 62D/759/CDV), Medical electrical equipment - Part 2-23: Particular requirements for basic safety and essential performance of transcutaneous partial pressure monitoring
equipment. See
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601223-D |
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601223-D-PDF |
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International Standard
IEC/CDV-1 60601-2-25 (IEC 62D/758/CDV), Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. See
more information
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601225-D |
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601225-D-PDF |
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International Standard
IEC/CDV-1 60601-2-27 (IEC 62D/745/CDV), Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic
monitoring equipment. See
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601227-D |
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601227-D-PDF |
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International Standard
IEC/CDV-1 60601-2-34 (IEC 62D/760/CDV), Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment.
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601234-D |
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601234-D-PDF |
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International Standard
IEC/CDV-1 60601-2-46 (IEC 62D/744/CDV), Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables. See
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601246-D |
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601246-D-PDF |
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International Standard
IEC/CDV-1 60601-2-49 (IEC 62D/761/CDV), Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment. See
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601249-D |
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601249-D-PDF |
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Implants and Artificial Organs
AAMI/American National Standard
AAMI/CDV-1 25539-03 (ISO/TC 150/SC 2 N528), Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters. See
more information
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2553903-D |
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2553903-D-PDF |
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International Standard
ISO/CD-V-1 25539-03 (ISO/TC 150/SC 2 N528), Cardiovascular implants - Endovascular devices - Part 3: Vena Cava Filters. See
more information
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2553903-D |
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2553903-D-PDF |
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Sterilization
AAMI Recommended Practice/American National Standard
AAMI/CDV-1 ST72, Bacterial endotoxin -Test methodologies, routine monitoring and alternatives to batch testing. See
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ST72-D |
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ST72-D-PDF |
$0/$25 |
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AAMI/ American National Standard
AAMI/CDV-2 14160, Sterilization of HC products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for
characterization, devel, valid, and routine control of a sterilization process for med devices. See
more information
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14160-D |
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14160-D-PDF |
$0/$25 |
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International Standard
ISO/DIS-1 14160, Sterilization of HC products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for
characterization, develel, valid, and routine control of a sterilization process for med devices. See
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14160-D |
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14160-D-PDF |
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International Standard
ISO/DIS-2 20857 (ISO DIS 20857.2), Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of an industrial sterilization process for medical devices.
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20857-D |
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20857-D-PDF |
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Symbols
AAMI/American National Standard
AAMI/CDV-4 15223-02, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation. See
more information
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1522302-D |
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1522302-D-PDF |
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