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Controlled-Rate Freezer
Regulatory | 84
Regulatory
Product Safety
This product family has been tested to applicable product safety standards by Underwriters Laboratories
(UL), which is a Nationally Recognized Test Laboratory (NRTL). The product bears the following mark
Medical Device Registrations
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US FDA Class II, KSE, 510(k) exempt.
21 CFR part 11
Disclaimer
The CryoMed models listed in this Operating and Maintenance manual support 21 CFR part 11 through a PDF file export and
touchscreen UI. It can be used as a document management system in a regulated environment.
It is the user’s responsibility to develop verification and validation protocol based on the record keeping requirements.
FCC Statement (USA)
Any changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of
the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to
correct the interference at his own expense.
Canadian ISED IC Notice
This ISM digital apparatus complies with Canadian ICES-001.
Cet appareil ISM est conforme á la norme NMB-001 du Canada.