| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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12-353
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| Standard | |
ANSI Z136.1-2022
American National Standard for Safe Use of Lasers |
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Scope/AbstractThis standard provides recommendations for the safe use of lasers and laser systems that operate at wavelengths between 180 nm and 1000 μm.
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Subsection 8.2.3 Multiple-Pulse Exposure Rule 3: Multiple-Pulse Correction Factor b) |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
Subsection 8.2.3 Multiple-Pulse Exposure Rule 3: Multiple-Pulse Correction Factor b) is in conflict with an existing regulation, 21 CFR 1040.10(d) Accessible Emission Limits and the laser multiple-pulse criteria in the published final guidance #1 referenced below. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §1040.10 |
Laser products.
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|
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| §1040.11 |
Specific purpose laser products.
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Laser Products - Conformance with IEC 60825-1 Ed.3 and IEC 60601-2-22 Ed.3.1 (Laser Notice No.56), Issued May 2019.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
