Compliance - AGFA CR 30-X User Manual

CR 30-X

Compliance

The CR 30-X 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 CR 30-X has been designed in accordance with the IEC 60601-1, Ed. 3:
Medical electrical equipment - Part 1: General requirements for basic safety
and essential performance.
Certificates
The CR 30-X complies with:
•
the general safety regulations:
IEC 60601-1:1988 + A1:1991 + A2:1995,
IEC 60601-1-1:2000 / EN 60601-1-1:2001,
IEC 60601-1-4:1999 / EN 60601-1-4:1996 + A1:1999,
IEC 60601-1-2: 2001 / EN 60601-1-2:2001,
UL 60601-1:2003,
CAN/CSA C22.2 No. 601.1,
ISO 14971:2000, 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,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11;
•
EN 540: 1993,
EN 980: 2003,
EN 1041: 1998,
ISO 18906: 2000,
EN ISO 13485: 2003;
• Additional standards for documentation,
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and
presentation
14
Introduction
Note: The CR 30-X is in compliance with the EG regulation 93/42/EEC
Directive (Medical Device).
2386B EN 20060926