Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. This action is appropriate because of the Center's intent to harmonize its requirements with many of those of the IEC standards.įDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. CDRH is also listing sections of its standard that contain requirements to which manufacturers must conform. CDRH plans to amend federal regulations for laser products to reflect those sections of the IEC standards. Hazard warning labels as specified in IEC 60825-1.ĬDRH will not object to conformance with many sections of IEC 60825-1, as amended, and IEC 6 as alternatives to comparable sections of 21 CFR §1040.10 and §1040.11.Lack of emission indicators or beam attenuators on Class II and Class IIIa systems, and.Be reported in accordance with 21 CFR §1002.10.ĬDRH has issued notices to laser product manufacturers and importers stating non-objection to:.Be certified and identified in accordance with 21 CFR §1010.2 and §1010.3, and.Laser products for introduction into commerce in or imported into the United States must: This guidance also describes additional requirements of the CDRH standard and alternate certification statements to be used with such products. This guidance describes the conditions under which laser product manufacturers may introduce into United States commerce laser products that comply with the IEC standards 60825-1, as amended, and 6. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Guidance for Industry and FDA Staff Guidance on Laser Products - Conformance with IEC 60825-1 and IEC 6 Please use the document number (1346) to identify the guidance you are requesting. You may obtain additional copies by sending an e-mail request to to receive an electronic copy of the guidance. Comments may not be acted upon by the Agency until the document is next revised or updated. When submitting comments, please refer to the exact title of this guidance document. Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Office of Communication, Education, and Radiation Programs Preface Public Comment 50), July 26, 2001.įor questions regarding this document contact Dan Hewett at 30 or Department of Health and Human Servicesĭivision of Mammography Quality and Radiation Programs 2 and IEC 6 Final Guidance for Industry and FDA (Laser Notice No. This document supersedes Laser Products – Conformance with IEC 60825-1, Am. harmonizing with the changes to the amendments to the general standard and other collateral standards.Center for Devices and Radiological Health redrafting of subclauses that altered instead of adding to the general standard or other collateral standards and correction of test method for relative humidity control at temperatures above 35 ☌ The most significant changes with respect to the previous edition include the following modifications: This second edition cancels and replaces the first edition of IEC 6, published in 2010, and constitutes a technical revision.
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other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. The home healthcare environment includes: - the dwelling place in which a patient lives It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. IEC 6:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment.