Standard: AAMI ID26

MEDICAL ELECTRICAL EQUIPMENT-PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS

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Scope:

The subclause has been changed from:

This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS and PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices are intended for use by medical staff and home PATIENTS as prescribed and medically indicated. These particular requirements do not apply to devices:

1) specifically intended for diagnostic or similar use (e.g., angiography or other pumps permanently controlled or supervised by the OPERATOR),

2) enteral infusion,

3) extracorporeal circulation of blood,

4) implantable or disposable devices,

5) EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressurevolume relationship of the urinary bladder when filled through a catheter with water),

6) EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography).

It now reads:

This Particular Standard specifies the requirement for INFUSION PUMPS, INFUSION CONTROLLERS, SYRINGE PUMPS, and PUMPS FOR AMBULATORY USE, as defined in 2.101 to 2.110. These devices are intended for use by medical staff and home PATIENTS as prescribed and medically indicated. These particular requirements do not apply to:

1) devices specifically intended for diagnostic or similar use (e.g., angiography or other pumps permanently controlled or supervised by the OPERATOR),

2) devices specifically intended for enteral infusion,

3) devices specifically intended for extracorporeal circulation of blood,

4) implantable or disposable devices,

5) EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressurevolume relationship of the urinary bladder when filled through a catheter with water),

6) EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography).

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami id26
Publish Date: 2004-12-09
Page Count: 68
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive
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