Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1Subject of the guidance regarding delivery system interlocks
Stakeholders
2Entity responsible for submitting NDINs
Responsibilities established by ANSI standards
Regulatory Context
Document Types
1The user instructions should summarize the testing that was performed.
Attributes
1Light generation parameter for device description.; Technical parameter in nanometers
Identified Hazards
Hazards
2Optical, electromagnetic, or x radiation from laser operation
Area in which radiation level exceeds the MPE
Standards & References
External Standards
2American National Standard for the Safe Use of Lasers in Health Care Facilities
Recognized laser safety standard for control measures
Specifications
1MPE boundaries for safety
Related CFR Sections (2)
- 21CFR1040.10§ 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11 , as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when:Read full regulation →
- 21CFR1040.11§ 1040.11 Specific purpose laser products.
(a) Medical laser products. Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:Read full regulation →
Related MFDS Guidelines
Korean regulatory guidelines covering similar topics
See Also (8)
- Laser Energy Source (Laser Notice 2) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)
- Viewing Optics - Sighting Telescope (Laser Notice 8) (Status: Final)
- Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9) (Status: Final)
- Identification Labels for Certain Class I Laser Products (Laser Notice 48) (Status: Final)
- Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40) (Status: Final)
- User Instruction Hazard Warnings (Laser Notice 35) (Status: Final)
- Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce (Laser Notice 25) (Status: Final)