Draft Standards Archives
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Biological Evaluation
AAMI/ American National Standard
AAMI/CDV-3 14155, Clinical investigation of medical devices for human subjects. See
more information
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14155-D |
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14155-D-PDF |
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International
ISO/DIS-2 14155, Clinical investigation of medical devices for human subjects. See
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14155-D |
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14155-D-PDF |
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Electromedical Equipment
AAMI/ American National Standard
AAMI/CDV-1 80001-01 (IEC 62A/668/CDV), Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities. See
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80001-D |
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80001-D-PDF |
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AAMI/ American National Standard
AAMI/CDV-2 62366, Medical devices - Application of usability engineering to medical devices. See
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62366-D |
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62366-D-PDF |
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International Standard
IEC/CD-1 60601-2-03 (IEC 62D/806/CD), Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment. See
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601203-D |
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601203-D-PDF |
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International Standard
IEC/CD-1 60601-2-06 (IEC 62D/808/CD), Medical electrical equipment - Part 2-6: Particular requirements for basic safety and essential performance of microwave therapy equipment. See
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601206-D |
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601206-D-PDF |
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International Standard
IEC/CD-1 60601-2-10 (IEC 62D/810/CD), Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. See
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601210-D |
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601210-D-PDF |
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International Standard
IEC/CDV-1 80001-01 (IEC 62A/668/CDV), Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities. See
more information
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80001-D |
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80001-D-PDF |
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International Standard
IEC/CDV-1 80601-2-12 (IEC 62D/790/CDV), Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators. See
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601212-D |
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601212-D-PDF |
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International Standard
IEC/CDV-1 80601-2-13 (IEC 62D/803/CDV), 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/CDV-1 80601-2-55 (IEC 62D/813/CDV), 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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GMP/Quality Systems
AAMI/ American National Standard
AAMI/CDV-1 13485:2003/C1 (Corrigendum), ANSI/AAMI/ISO 13485:2003, Corrigendum 1. See
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13485-AD |
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13485-AD-PDF |
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Implants and Artificial Organs
AAMI/ American National Standard
AAMI/CDV-1 12962, Implants for surgery - Active implantable medical devices - Pacemaker magnet mode response. See
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12962-D |
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13485-D-PDF |
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International Standard
ISO/CD-1 12962 (ISO/TC 150/SC 6 N 199), Implants for surgery - Active implantable medical devices - Pacemaker magnet mode response. See
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12962-D |
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13485-D-PDF |
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Sterilization
AAMI Recommended Practice/American National Standard
AAMI/CDV-2 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 |
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Syringes and Needles
International Standard
ISO/DIS-1 23908-01, Safety issues for needles - Requirements and test methods - Part 1: Sharps injury protection. See
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2390801-D |
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2390801-D-PDF |
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