JGR PDL 5, User Manual, Page: 7 / 83

PDL5 User Manual
PDL5-UM-00001 Rev 001 1
1
COMPLIANCE
FDA-CDRH Compliance
Under the US Food and Drug Administration (FDA) Center for Devices and
Radiological Health (CDRH), the unit complies with the Code of Federal
Regulations (CFR), Title 21, Subchapter J, which pertains to laser safety and
labeling. See the link below for more information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF
RPartFrom=1000&CFRPartTo=1050
CSA / IEC Compliance
The unit complies with certain standards of the Canadian Standards Association
(CSA) and the International Electrotechnical Commission (IEC).
The unit falls in the Installation Category (Overvoltage Category) II under IEC 664.
IEC 664 relates to impulse voltage levels and insulation coordination. The
particular category is defined as: local level, appliances, portable equipment, etc,
with smaller transient overvoltages than Installation Category (Overvoltage
Category) III.
The unit falls in the Pollution Degree 2 category under IEC 1010-1 and CAN/CSA-
C22.2 No. 1010.1. The IEC standard on Safety Requirements for Electrical
Equipment for Measurement, Control, and Laboratory Use relates to insulation
coordination. The CSA standard is on Safety Requirements for Electrical
Equipment for Measurement Control, and Laboratory Use, Part I: General
Requirements. The Pollution Degree 2 category is defined as follows: “Normally
only non-conductive pollution occurs. Occasionally, however, a temporary
conductivity caused by condensation must be expected.”