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Lasers in Health Care
This category covers lasers used in the medical industry. Lasers used in healthcare include safe use of lasers, particular requirements, ophthalmics and other standards.
ANSI Z136.3-2024
Safe Use of Lasers in Health Care
The ANSI Z136.3 (2024) is nationally recognized as the definitive document on laser safety in all health care environments, providing guidance for the safe use of lasers for diagnostic, cosmetic, preventative and therapeutic applications where bodily structure or function is altered or symptoms are relieved. This standard is applicable to any location where a health care laser system (HCLS) is used as a medical device, including hospital facilities, ambulatory surgery centers, individual medical, dental and veterinarian offices, and non-medical locations, such as salons and spas. It is intended for use by all personnel associated with the installation, use, operation, maintenance and service of the HCLS, as well as anyone who might be at risk of exposure to the laser beam during a health care application procedure. Extensively revised to reflect current thinking and practice, updates to the Z136.3 (2024) include: - Harmonization with the ANSI Z136.1 Safe Use of Lasers; Clarification concerning signage; Updates to the informative appendices; Updated references to International Standards. The Z136.3 standard is a must for all medical LSOs. It is a proven key to implementing and maintaining a successful medical laser safety program, and provides the foundation for facility policies, criteria for education and training, and compliance with best practices.
ANSI Z136.1 and Z136.3 Combination Set
Safe Use of Lasers and Safe Use of Lasers in Health Care Facilities
This combination set contains ANSI Z136.1-2014 and ANSI Z136.3-2018
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IEC 60601-2-22 Ed. 4.0 b:2019
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4. Medical Electrical Equipment or Medical Electrical Systems which incorporate lasers as sources of energy being transferred to the Patient or animal and where the lasers are specified as above, are referred to as “laser equipment” in this document. Laser Products for these applications classified as a Class 1, Class 1M, Class 2, Class 2M or Class 3R Laser Product, are covered by IEC 60825-1:2014 and by the general standard. 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 to ME Equipment and to ME Systems, as relevant. Hazards inherent in the intended physiological function of laser equipment within the scope of this document are not covered by specific requirements in this document except in 7.2.13, Physiological effects, of the general standard. If the laser equipment is Class 1C according to IEC 60825-1:2014 and is used as a laser appliance in a household, it is covered by IEC 60335-2-113:2016. This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition;
b) it addresses technical and safety issues which have arisen since publication of the third edition;
c) the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4;
d) LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.
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IEC 60601-2-57 Ed. 2.0 b:2023
Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
IEC 60601-2-57:2023 applies to basic safety and essential performance of equipment incorporating one or more sources of optical radiation in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create photobiological effects in humans for therapeutic, diagnostic, monitoring, and cosmetic or aesthetic applications; hereafter referred to as light source equipment (ls equipment).
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ANSI Z80.11-2012 (R2022)
Ophthalmics - Laser Systems for Corneal Reshaping
This standard applies to any laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance. This standard addresses the vocabulary, performance requirements, labeling, and clinical investigations necessary for this type of device.
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