How Much Does 21 CFR 1040.10 Testing Cost?

What Is 21 cfr 1040.10?

The full title of 21 CFR 1040.10is Title 21 of the Code of Federal Regulations, Section 1040.10 – Laser Products Requirements.

Essentially, it is similar to iec 60825-1and GB 7247.1, which are standards used to classify laser product safety levels, determine testing methods, specify protective requirements, and provide labeling guidelines for laser products.

However, in the United States, 21 CFR 1040.10is a mandatory regulation, not just a standard, meaning its compliance level and enforcement are higher.

The FDA (Food and Drug Administration)acts as the regulatory body overseeing radiation-emitting products in the U.S., and laser products must comply with 21 CFR 1040.10requirements.

21 CFR 1040.10 Testing Cost

The testing cost for 21 CFR 1040.10is USD $798, though the exact fee varies depending on the product type.

For detailed pricing, please contact JJR Laboratory.

FDA 21 CFR 1040.10 Laser Safety Classifications

Class I Laser Products

Laser products where, during operation, human exposure to laser radiation never exceeds the emission limits listed in Table I of 21 CFR Subchapter J Part 1040.10.

Class I laser radiation is not considered hazardous.

Class II Laser Products

Laser products where exposure to visible laser radiation exceeds the limits in Table II-Abut does not exceed the limits in Table II of 21 CFR Subchapter J Part 1040.10.

Class II laser radiation is considered to pose a chronic viewing hazard.

Class IIIa Laser Products

Laser products where exposure to visible laser radiation exceeds the limits in Table IIbut does not exceed the emission limits in Table III-A of 21 CFR Subchapter J Part 1040.10.

Depending on irradiance, Class IIIa laser radiation is considered to present an acute intrabeam viewing hazardor chronic viewing hazard, and direct observation with optical instruments is considered acutely hazardous.

Class IIIb Laser Products

Laser products where exposure to visible laser radiation exceeds the limits in Table III-Abut does not exceed those in Table III-B of 21 CFR Subchapter J Part 1040.10.

Class IIIb laser radiation poses acute hazards to the skin and eyes from direct exposure.

These products may have removable panels, and when opened, exposure levels may range from Class II to Class IV.

Class IV Laser Products

Laser products where exposure exceeds the limits in Table III-B of 21 CFR Subchapter J Part 1040.10.

Class IV laser radiation poses acute hazards to the skin and eyesfrom both direct and scattered radiation.

Such products may also have removable panels, and when opened, exposure may range from Class II to Class IVlevels.

Should Laser Products Exported to the U.S. Be Tested According to 21 CFR 1040.10 or iec 60825-1?

In Laser Notice No. 50issued by the FDA in 2007, the agency announced that certain sections of 21 CFR 1040.10can be substituted with equivalent requirements from IEC 60825-1and iec 60601-2-22:

Sections that can be substitutedinclude:

- 1040.10(b) Definitions

- 1040.10(c)(1) Classification

- 1040.10(d) Accessible emission limits

- 1040.10(e) Tests for determination of compliance

- 1040.10(f)(1) Protective housing

- 1040.10(f)(2) Safety interlocks

- 1040.10(f)(3) Remote interlock connector

- 1040.10(f)(4) Key control

- 1040.10(f)(5) Laser radiation emission indicator

- 1040.10(f)(6) Beam attenuator

- 1040.10(f)(7) Location of controls

- 1040.10(f)(8) Viewing optics

- 1040.10(f)(9) Scanning safeguard

- 1040.10(g) Labeling requirements

- 1040.10(h)(1) User information

- 1040.11(a) Medical laser products

Sections that cannot be substituted(must comply with 21 CFR 1040.10) include:

- 1010.2 Certification

- 1010.3 Identification

- 1010.4 Variances

- 1040.10(a) Applicability

- 1040.10(c)(2) Removable laser systems

- 1040.10(f)(10) Manual reset mechanism

- 1040.10(h)(2) Purchasing and servicing information

- 1040.10(i) Modification of a certified product

- 1040.11(b) Surveying, leveling, and alignment laser products

- 1040.11(c) Demonstration laser products

Testing directly according to 21 CFR 1040.10is the most straightforward and FDA-compliant method.

If your product has already been tested according to IEC 60825-1or IEC 60601-2-22, you must add tests for the non-substitutable sectionslisted above to ensure full compliance with 21 CFR 1040.10.

Quality Assurance:

The laboratory strictly adheres to the ISO 17025quality management system, ensuring precise control over testing processes and reliable, high-quality results.