Weiner Associates Services
Below is a listing of services that are typically provided to laser product manufacturers to assist them in complying with the U.S., European, and international laser safety standards. Detailed information on these and other laser safety services are available from Weiner Associates.
Laser Safety Service
- Review the impact of the laser safety requirements on the product design, and assist in defining any required changes. The review covers the regulations from the U.S. FDA Center for Devices and Radiological Health (CDRH) in 21 CFR 1040 and the requirements of the IEC/EN 60825-1 laser safety standard.
- Prepare a final draft of the Product Report to the CDRH, include any required calculations.
- Provide a description of the labels required for the product to comply with the U.S., European, and international laser safety standards.
- Prepare lists of the CDRH requirements applicable to the user's manual, service manual, and sales literature.
- Prepare a list of the test requirements appropriate to verify operation of the required laser safety features and to measure laser power/energy levels (if needed).
- Review the documents prepared by the Client in response to items 4 and 5 above.
- Review the CDRH record-keeping, documentation, and annual reporting requirements with Client.
- Provide brief summaries of the applicable state regulations and the European/international laser safety requirements.
- Visit Client's facility for a period of one day to discuss the regulations, to become familiar with the product configuration, and to work on the above-listed tasks.
- Assist with non-compliance paperwork and required notifications for products shipped to date. Prepare request for exemption from corrective action, if appropriate.
- Prepare a report documenting conformance of the product to the laser safety requirements in the IEC/EN 60825-1 international laser safety standard
- Provide laser exposure calculations per ANSI Z136, state, or other user standards.
- Prepare drafts of a Variance Application and Laser Light Show Report, including required calculations.
- Perform safety audit prior to plant visit by FDA/CDRH or state radiation control personnel.
- Assist Client's customers with laser safety issues relating to installation or operation of Client's equipment.