LKC TECHNOLOGIES RETeval - Approvals

Regulatory and Safety Information
RET eval Device User Manual 98
Approvals
This product has been tested for and complies with the requirements of the following standards:
ISO 15004-1 Ophthalmic instruments, General requirements
ISO 15004-2 Ophthalmic instruments, Light protection hazard
IEC 60601-2-40 Medical electrical equipment (2
nd
edition)
IEC 60601-1 Medical electrical equipment (3.1 edition) CB Scheme
IEC 60601-1 Medical electrical equipment (3
rd
edition) CB Scheme
AAMI ES60601-1 Medical electrical equipment
CSA C22.2#60601-1 Medical electrical equipment
CENELEC EN60601-1 Medical electrical equipment (3
rd
edition)
IEC 60601-1-2 Electromagnetic compatibility, including Japan deviations (4
th
edition)
IEC 60601-1-6 Usability
IEC 62366 Usability
IEC 60601-1 Medical electrical equipment (2
nd
edition) CB Scheme
UL 60601-1 UL Standard for Safety medical electrical equipment (2
nd
edition)
CSA C22.2#601.1 Medical electrical equipment (2
nd
edition)
CENELEC EN60601-1 Medical electrical equipment (2
nd
edition)
IEC 60601-1-6 Usability (2
nd
edition)
ANSI/AAMI/ISO 10993-1 Biological evaluation of medical devices