Standard: AAMI 60601-2-16

MEDICAL ELECTRICAL EQUIPMENT, PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEMODIALYSIS, HEMODIAFILTRATION AND HEMOFILTRATION EQUIPMENT

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

FEATURES & BENEFITS
  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

Addition:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEMODIALYSIS, HEMODIAFILTRATION and HEMOFILTRATION EQUIPMENT, hereafter referred to as HEMODIALYSIS EQUIPMENT.

This International Standard does not take into consideration the DIALYSIS FLUID control system of HEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID and CENTRAL DELIVERY SYSTEMS. It does however take into consideration the specific safety requirements of such HEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.

This International Standard specifies the minimum safety requirements for HEMODIALYSIS EQUIPMENT. These devices are intended for use either by medical staff or for use by the PATIENT or other trained personnel under the supervision of medical expertise.

This International Standard includes all ME EQUIPMENT that is intended to deliver a HEMODIALYSIS, HEMODIAFILTRATION and HEMOFILTRATION treatment to a PATIENT suffering from kidney failure.

The particular requirements in this International standard do not apply to:

– EXTRACORPOREAL CIRCUITS;

- DIALYZERS;

- DIALYSIS FLUID CONCENTRATES;

- water treatment equipment;

- equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1.

NOTE See also 4.2 of IEC 60601-1:2005.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 60601-2-16
Publish Date: 2012-01-01
Page Count: 80
Change Type: COMPLETE REVISION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active
Advertisement
Advertisement
Advertisement
Advertisement