Compliance - AGFA CR 30-X User Manual

CR 30-X/CR 30-X
M

Compliance

The digitizer has been designed in accordance with the MEDDEV Guidelines
relating to the application of Medical Devices and have been tested as part of
the conformity assessment procedures required by 93/42/EEC MDD
(European Council Directive 93/42/EEC on Medical Devices).
The digitizer has been designed in accordance with the IEC 60601-1, Ed. 2:
Medical electrical equipment - Part 1: General requirements for basic safety.
Certificates
The digitizer complies with:
•
the general safety regulations:
IEC 60601-1 / EN 60601-1,
IEC 60601-1-1:2000 / EN 60601-1-1:2001,
IEC 62304:2006 / EN 62304:2006,
IEC 60601-1-6:2006 / EN 60601-1-6:2007,
IEC 60601-1-2:2007 / EN 60601-1-2:2007,
UL 60601-1:2003,
CAN/CSA C22.2 No. 601.1,
ISO 14971:2009, Medical devices - Application of risk management to medical
devices.
•
the laser safety regulations:
IEC 60825-1:2001 / EN 60825-1:1994 + A1:2002 + A2:2001,
IEC 60825-1:2007 / EN 60825-1:2007,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11;
•
EN 540: 1993,
EN 980: 2008,
EN 1041: 2008,
ISO 18906: 2000,
EN ISO 13485: 2003 / AC: 2009;
•
Additional standards for documentation,
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and
presentation
14
Introduction
Note: The digitizer is in compliance with the EG regulation 93/42/EEC
Directive (Medical Device).
2386G EN 20120110