LUMENIS smart532 - 2.10. Compliance with International Standards

UM-1151140EN, Rev. C, May 2016
2-13
Smart532
™
Laser Safety and Regulatory
2.10. Compliance with
International
Standards
Lumenis lasers and delivery systems comply with the current revision of
21 CFR Part 1040, Chapter I, Subchapter J (Performance Standards for
Light-Emitting Products), as administered by the Center for Devices and
Radiological Health of the US Food and Drug Administration (FDA).
CE-labeled devices comply with all appropriate performance standards as
specified in Annex II of the European Medical Device Directive MDD
93/42/EEC.
The Smart532 laser system is classified as Class IV lasers by the Center
for Devices and Radiological Health of the Food and Drug Administration
and as Class 4 by the International Standard IEC 60825.
Refer to the current revisions of the American National Standard (ANSI)
publications Z136.3, ANSI Z136.1 and EN 207 for recommendations on
the safe use of lasers in health care facilities.
The current revisions of the American National Standards Institute
specification ANSI Z136.3 & Z136.1 and EU standard EN 207 include
very thorough discussions of laser safety and guidelines for medical laser
use. These standards were developed in the earliest days of lasers and are
routinely revised to keep up with growing technology. ANSI Z136.3 and
EN 207 are written specifically for the use of lasers in medicine. While
non-binding, the guidelines are excellent guides for an office or institution
seeking to set up a formal safety program.
Lumenis strongly recommends that operators read these two ANSI and
EN 207 standards before using a laser in clinical practice.
The Smart532 system is designed to comply with current revisions of the
following international standards:
● IEC 60601-1: Medical Electrical Equipment - Part 1: General
requirements for Basic Safety and Essential
Performance.
● IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General
Requirements for Safety - Collateral Standard:
Electromagnetic Compatibility - Requirements
and Tests.
● IEC 60601-2-22: Medical Electrical Equipment - Part 2-22:
Particular Requirements for Basic Safety and
Essential Performance of Surgical, Cosmetic,
Therapeutic and Diagnostic Laser Equipment.
● IEC 60825-1: Safety of Laser Products - Part 1: Equipment
Classification and Requirements.
● IEC 60601-1-6: Medical Electrical Equipment - Part 1-6: General
Requirements for Basic Safety and Essential
Performance - Collateral Standard: Usability.