| |
Draft Laser Notice No. 56 on IEC 60825-1 Edition 3 published
Last Friday, the FDA/CDRH issued their notice on the availability of the draft Laser Notice No. 56, calling for comments until March 20th, 2018.
According to the draft LN 56, CDRH accepts IEC 60825-1 Edition 3 for the classification and labeling of laser products, based on some conditions. Besides the conditions and additional requirements (such as a certification label) that applied already for Edition 2 under LN 50, some subclauses of IEC 60825-1 Edition 3 are listed in the draft laser notice as “not comparable to FDA performance standards”. Amongst others, this relates to products where lasers replace lamps or where non-laser (collateral) radiation is emitted, i.e. mainly subclause 4.4. Specific guidance to deal with this kind of product and emission is under development (to become Laser Notice No. 57). IEC 60601-2-22 Ed. 3.1 for medical laser products is also referenced where applicable. It is difficult to predict when the actual LN 56 will become available, but it can be expected that there will be some processing time after the deadline for comments of March 20th, 2018.
>> Link to FDA Notice, submission of comments
>> Link to Draft Laser Notice No. 56
|
|
ILSC 2019
"Mark your calendar" for the International Laser Safety Conference ILSC 2019 in Orlando at Lake Buena Vista, from March 18th to 21st, 2019. Our Karl Schulmeister is honored to serve as Conference Chair of the Scientific Sessions; we will send another news email once the call for papers is open.
|
Newsletter 2/2018