Classification to CDRH & ANSI

CDRH-Classification and ANSI Z136.1 Classification

CDRH-Classification

In the USA, laser products are classified and labelled according to the product performance standard 21 CFR §1040.10 and §1040.11. The legel status of this “standard” is not comparable to IEC 60825-1 which is on its own not mandatory, as this is a code of federal regulation and therefore it is mandatory to comply with it. 

The classification scheme is similar to the one of the IEC 60825-1. However, the CDRH-limits and measurement requirements have not been changed for some time and are no longer what could be considered “state of the art”. For this reason, the classification, the design requirements and the ”warning“ labels of IEC 60825-1 are also accepted by the CDRH, which is stated in the Laser Notice 50 of the CDRH. 

Although we are also accredited for the classification and testing w.r.t. the CDRH Federal Laser Product Performance Standard, we recommend to classify a product according to the IEC 60825-1, particularly for more complex sources such as extended sources, pulsed sources or scanned sources.  Independent of testing of products, we offer to help filling out the mandatory CDRH product report. [see consulting services].

ANSI-Classification

The US-American standard ANSI Z136.1 is not a standard pertaining to the safety of products to be placed on the market, but contains information pertaining to user safety, i.e. user precautions. However, it also comprises a product classification scheme which is very similar to IEC classification (with insignificant differences concerning measurement requirements).  It should be noted that the classification on the basis of ANSI Z136.1 has not official bearing with respect to the CDRH regulations and for placing onto market in the USA and elsewhere. The ANSI standard is “officially” only relevant for laser users in the USA.    

Nevertheless we offer a classification according to ANSI Z136 on demand, as this classification is sometimes requested by purchasers of laser products.

 

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