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Public Review Proposed Reaffirmation
Deadline for comments: 12-Mar-10
AAMI/ American National Standard
AAMI/DS-1 EC12-Reaff2, Proposed reaffirmation of ANSI/AAMI EC12:2000, Disposable ECG electrodes. See
more information
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EC12 |
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EC12-PDF |
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Deadline for comments: 23-Apr-10
AAMI/ American National Standard
AAMI/DS-1 10993-11-Reaff, Proposed reaffirmation of ANSI/AAMI/ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity. See
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1099311 |
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1099311-PDF |
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Public Review Draft
Deadline for comments: 12-Mar-10
AAMI/ American National Standard
AAMI/CDV-2 13022 (ISO/TC 194/SC 1 N128), Application of risk management to medical products containing viable human cells. See
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13022-D-PDF |
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Deadline for comments: 12-Mar-10
International Standard
ISO/CD-V-2 13022, Application of risk management to medical products containing viable human cells. See
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13022-D |
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13022-D-PDF |
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Deadline for comments: 29-Mar-10
AAMI/ American National Standard
AAMI/CDV-1 60601-2-16, Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and
haemofiltration equipment. See
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601216-P-PDF |
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Deadline for comments: 08-Apr-10
International Standard
ISO/CD-V-2 11608-01, Needle-based injection systems for medical use -- Requirements and test methods - Part 1: Needle-based injection systems. See
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1160801-D |
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1160801-D-PDF |
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Deadline for comments: 08-Apr-10
International Standard
ISO/CD-V-2 11608-02, Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles. See
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1160802-D |
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1160802-D-PDF |
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Deadline for comments: 08-Apr-10
International Standard
ISO/CD-V-2 11608-03, Needle-based injection systems for medical use -- Requirements and test methods -- Part 3: Container closures. See
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1160803-D |
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1160803-D-PDF |
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Deadline for comments: 08-Apr-10
International Standard
ISO/CD-V-2 11608-05, Needle-based injection systems for medical use -- Requirements and test methods -- Part 5: Automated functions. See
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1160805-D |
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1160805-D-PDF |
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Deadline for comments: 09-Apr-10
AAMI/ American National Standard
AAMI/CDV-1 ST15883-02, Washer-disinfectors, Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc. See
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1588302-D |
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1588302-D-PDF |
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Deadline for comments: 09-Apr-10
AAMI/ American National Standard
AAMI/CDV-1 ST15883-03, Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers. See
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1588303-D |
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1588303-D-PDF |
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Deadline for comments: 09-Apr-10
AAMI/ American National Standard
AAMI/CDV-1 ST55, Table-top steam sterilizers. See
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Deadline for comments: 23-Apr-10
AAMI/ American National Standard
AAMI/CDV-1 11663 (ISO 11663:2009), Quality of dialysis fluid for haemodialysis and related therapies. See
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11663-P |
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11663-P-PDF |
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Deadline for comments: 23-Apr-10
AAMI/ American National Standard
AAMI/CDV-1 23500, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies. See
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23500-D |
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23500-D-PDF |
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Deadline for comments: 23-Apr-10
International Standard
ISO/CD-1 14708-02 (ISO/TC 150/SC 6 N 202), Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers. See
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1470802-D |
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1470802-D-PDF |
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Deadline for comments: 23-Apr-10
International Standard
ISO/CD-V-1 10555-01, Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements. See
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1055501-D |
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1055501-D-PDF |
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Deadline for comments: 23-Apr-10
International Standard
ISO/DIS-1 11040-02, Prefilled syringes -- Part2: Plunger stoppers for dental local anaesthetic cartridges. See
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1104002-D |
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1104002-D-PDF |
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Deadline for comments: 23-Apr-10
International Standard
ISO/DIS-1 11040-05, Prefilled syringes -- Part 5: Plunger stoppers for injectables. See
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1104005-D |
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1104005-D-PDF |
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