Kaye ValProbe RT - Ingress Protection for Kaye Valprobe RT Logger; United States FDA 21 CFR Part 11 Complaint Software Application

Appendix B. Regulatory Compliance and Agency Approvals
ValProbe RT User Manual 157
B.2.2 European Radio and EMC Certification Approvals:
Kaye ValProbe RT is certified to Europe Radio and EMC standards listed
below:
ETSI EN 300 328 V2.1.1:2016-11 Wideband transmission systems; Data
transmission equipment operating in the 2,4 GHz ISM band and using wide
band modulation techniques - RED (2014/53/EU).
ETSI EN 301 489-1 V2.2.0:2017-03 Electromagnetic Compatibility (EMC)
standard for radio equipment and services; Part 1: Common technical
requirements - RED (2014/53/EU).
ETSI EN 301 489-17 V3.2.0:2017-03 Electromagnetic Compatibility (EMC)
standard for radio equipment and services; Part 17: Specific conditions for
Broadband Data Transmission Systems - RED (2014/53/EU).
EN 62311:2008 Assessment of electronic and electrical equipment related to
human exposure restrictions for electromagnetic fields (0 Hz - 300 GHz) -
RED (2014/53/EU) and LVD (2014/35/EU).
EN 61326-1:2013 EMC requirements for Electrical equipment for
measurement, control and laboratory use; Part 1: General requirements –
EMC directive 2014/30/EU.
IEC 61326-1:2012 EMC requirements for Electrical equipment for
measurement, control and laboratory use; Part 1: General requirements -
ISO/IEC Directives, Part 2.
B.3 Ingress Protection for Kaye ValProbe RT Logger
Kaye ValProbe RT Logger is certified to EN60259 / IP68 Ingress Protection standard.
IP68 Ingress Protection (IP code): Degrees of protection provided by enclosures as
per EN 60529:1991+A1:2000+A2:2013 standard.
IP6X: Protection against access to hazardous and solid foreign objects and dust proof
test.
IPX8: Protection against continuous immersion in water test.
B.4 United States FDA 21 CFR Part 11 Complaint
Software Application
Kaye ValProbe RT product software application is complaint to US FDA 21 CFR
Part 11 regulatory standard for electronic records and electronic signatures.
US FDA 21 CFR Part11; United States Food and Drug Administration,
Department of Health and Human Services – General Provisions; Electronic
Records; Electronic Signatures.