Newsletter 1/2019

CDRH issues Laser Notice 56, accepting Edition 3.0 of IEC 60825-1

Laser Notice 56 was issued on May 8th 2019 by the FDA/CDRH and can be downloaded from:

Under the conditions described in Laser Notice 56, conformance with IEC 60825-1 Ed. 3 is assumed by the FDA to result in adequate safety for laser products similar to performance standards in the FDA’s regulations. For medical products, IEC 60601-2-22 Edition 3.1 is referenced. Laser Notice 56 also lists some clauses of IEC 60825-1 Ed. 3.0 which are considered as not comparable to FDA laser performance standards; these relate mostly to collateral radiation. Subclause 4.4 on laser driven lamp products is not accepted in a general way, but only for laser illuminated projectors that fulfil the conditions laid down in Laser Notice 57. The two IEC Interpretation sheets are noted in relation to classification of the product, but there appears to be a typographical error for Interpretation Sheet 2, since IEC 60825-1/ISH2 is first correctly referenced but then the title of IEC 60825-2 (“Part 2”) is mentioned.

Since it is specifically stated that Laser Notice 56 does not replace Laser Notice 50 (related to Edition 2 of IEC 60825-1), Laser Notice 50 can be continued to be applied.

CDRH issues Laser Notice 57 on classification requirements for laser illuminated projectors

Laser Notice 57 was issued on May 8th 2019 by the FDA/CDRH and can be downloaded from:

The guidance in Laser Notice 57 outlines how to determine if a product is a Laser Illuminated Projector (LIP), how to classify the product into a risk group (referencing IEC 62471-5), and how to meet appropriate safety requirements. Some of the requirements for classification and user information are stricter than IEC 62471-5. For instance, for products with apparent sources smaller than 11 mrad (determined at 1 m), the limit for Risk Group 2 LIP where Laser Notice 57 applies is reduced by a factor of up to 2.2.

This guidance replaces the Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs) dated February 18th, 2015.

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