Laser & Lighting - Hermon Laboratories

Laser & Lighting

Lighting safety testing

New emerging lighting technologies ensure enhanced performance and safety in both public and private spaces.

Our experts test your products in accordance with lamp standard IEC/EN/SI 62560 and lighting standard IEC/EN 60598 (SI 20). During that process, they examine the safety from electric shock and fire, photobiology of lamps on the basis of IEC 62471 and blue light hazard according to IEC/TR 62778.

We provide comprehensive testing services for a wide variety of lighting products in our accredited laboratory to ensure your products receive type approvals relevant to Israel and international markets. The support provided by our experts ranges from testing during product development to the mandatory approval of imported products.

Laser safety testing

Laser Safety testing includes all product types and categories employing laser source, including Medical and Dental Equipment, Laboratory and Measurement Equipment, Information Technology Equipment, Audio/Video Equipment, Fiber Optic Telecom Equipment, and many others.

LED safety testing and classifying laser, LED, UV and IR products and components to global laser safety regulations. We perform laser safety testing and radiation measurements required for laser classification, and offer International approvals for various markets.

Based on the testing and classification, we prepare IEC/EN 60825 reports and can also do US FDA CDRH filing. Our experienced team has certified Laser Safety Officers who can also help developing and implementing your company laser safety program and laser safety testing.

Europe

The European Directives require that products be marked with the “CE” Mark to indicate compliance with all applicable EN safety standards before they can be legally introduced into the EU marketplace. If a product or a component incorporates a laser, then the product would be required to be in compliance with the standard for safety of laser products EN 60825 to address laser radiation hazard concerns.

USA

US Federal Law requires testing and classification of laser product to US FDA 21CFR1040, before it can be legally introduced into US market.
Laser Notice No. 50 is an FDA guidance document that determines what IEC 60825 can be used to meet requirements found in 21CFR1040 for products employing lasers intended for sale in the United States. Laser Notice No. 50 allows manufacturers to submit reports for products demonstrating compliance to IEC 60825 as an alternative for meeting test data requirements in 21CFR1040.

The Product Report detailing compliance with 21CFR requirements is required be filed with the US FDA CDRH to obtain an Accession number issued to specific product. Many laser product manufacturers only file a Product Report and overlook the additional reports required to be filed with the US FDA CDRH as applicable to production. Failure to prepare and file all required CDRH report may result in fines when audited, i.e. Supplemental report, Annual report, Abbreviated report, Radiation Quality Control report, Radiation Test Result report, Dealer and Distribution report, Incident report, Defect report, Variance report, etc.

http://www.fda.gov

Canada

In Canada, the national laser product safety regulations is the Radiation Emitting Devices Act, Chapter R-1:2001, (RED) issued by Department of Justice Canada, “An Act respecting the sale and importation of certain radiation emitting devices.” RED refers to both 21CFR and IEC 60825 as the prescribed regulations for the purpose of radiation protection to persons. Depending on the particular Canadian province and the local Canadian authority having jurisdiction, either 21CFR or IEC 60825 compliance is required for laser products introduced in Canadian commerce.

http://canada.justice.gc.ca

International

Most countries outside of the US, Canada and Europe require compliance with IEC 60825.

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