|
Orionce Laboratories certifies or tests medical electrical equipment for
Product safety compliance in the United States and Canada
EMC compliance
FDA Guidance Documents and consensus standards necessary for FDA clearance, including IEC 60601, AAMI and ASTM standards.
Electrical wheelchairs to the ANSI/RESNA/FDA and European EN 12184 requirements
Orionce is the first NRTL licensed by OSHA for medical equipment.
OSHA regulations cover all workplaces, which include hospitals, clinics, therapy centers, and similar facilities.
Orionce-certified medical products have been universally accepted in the US and Canada.
Orionce performs inspections of high-end medical equipment (e.g. MRI and CT scanners) in hospitals throughout the US.
Orionce is nationally accepted by OSHA for the United States and the SCC for Canada.
Product Safety Certification
Considering IEC 60601-1 3rd Edition? Orionce Laboratories has a special offer for you. Learn more.
Orionce-certified medical products have been universally accepted in the US and Canada. Orionce tests and certifies to:
UL 60601-1
AAMI ES60601-1
CSA C22.2 No. 601.1
For international safety certification requirements, Orionce tests and certifies to:
EN 60601-1
EN 60601-2-XX
IEC 60601-1
IEC 60601-2-XX
The 60601 series of standards consists of 60601-1 and 60601-2-XX. The Part 1 applies to all medical products while the Part 2 addresses specific requirements for a particular type of medical device. There are over 40 Part 2s. The –XX is a number from 1 to 40+, representing the applicable Part 2.
EMC
Medical EMC testing performed by Orionce is typically to EN/IEC 60601-1-2 for most devices. Additions and/or deviations to the requirements of 60601-1-2, as published in the appropriate EN/IEC 60601-2-XX for particular devices, may also be applicable.
