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Standards Spotlight

Views of Real-World Impact

ANSI shines a spotlight on Standards in action as they support safety, efficiency, and well-being in interesting aspects of everyday life.

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Standards in the Spotlight: Robotically Assisted Surgery and Machine Safety

10/16/2020

In an effort to communicate the vital role that standards play in daily life, the American National Standards Institute (ANSI) publishes snapshots of the diverse standards initiatives undertaken in the global and national standards arena, many of which are performed by ANSI members and ANSI-accredited standards developers. Two of the latest selections follow:

Robotically Assisted Surgical Equipment

Robotically assisted surgery uses a minimally-invasive approach, where surgeons make small incisions and insert miniature instruments and a high definition camera in order to perform the surgery. Robotically assisted surgeries can enable higher precision and faster recovery time than traditional surgeries. An American National Standard (ANS) on robotically assisted surgical equipment has been developed by the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI member and accredited standards developer.

ANSI/AAMI/IEC 80601-2-77:2020, Medical Electrical Equipment - Part 2-77: Particular Requirements For The Basic Safety And Essential Performance Of Robotically Assisted Surgical Equipment, applies to the basic safety and essential performance of robotically assisted surgical equipment (RASE) and robotically assisted surgical systems (RASS) together with their interface conditions.This standard does not apply to X-ray-based image-guided radiotherapy equipment and does not cover hazards inherent in the intended physiological function of medical electrical equipment.

Safety of Machinery

All machines come with some level of risk. According to the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA), workers who operate and maintain machinery suffer approximately 18,000 injuries and more than 800 deaths per year.

Standards provide a way to mitigate risk and keep machine use safe.  An ANS on the safety of machinery has been updated by the B11 Standards Inc., an ANSI member and accredited standards developer.

ANSI B11.0-2020, Safety Of Machinery, outlines procedures for identifying hazards and estimating and evaluating risks during relevant phases of the machine lifecycle. It also helps eliminate hazards and offers provisions for sufficient risk reduction, giving guidance for documentation and verification to support these processes.

This standard applies specifically to new, existing, modified, or rebuilt power driven machines (not portable by hand while working) used to process materials by various processes. These include cutting, forming, pressure, electrical, lamination, or thermal or optical techniques, as well as a combination of these processes.

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