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Technical Data Chapter 4
Page 98
4.5 Compliance / Approvals
The MiroCam capsule endoscope system and accessories complies with
the Medical Device Directive 93/42/EEC (CE
0843
).
In addition, the product complies with
IEC 60601-1:1988 +
A1:1991 + A2:1995
(EN 60601-1:1990 +
A1:1992 + A2:1995)
Medical Electrical Equipment, Part 1 :
General requirement for safety
EN 60601-1-1:2001
Medical Electrical Equipment, Part 1 :
General requirement for safety
Collateral Standard : Medical
Electrical System
EN 60601-1-2:2001
Medical Electrical Equipment, Part 1 :
General requirement for safety
Collateral Standard : Electromagnetic
compatibility
EN 60601-1-4:1998
Medical Electrical Equipment, Part 1 :
General requirement for safety
Collateral Standard : Programmable
Electrical Medical System
EN60601-2-18:1996
Medical Electrical Equipment, Part 2 :
Particular requirement for the safety
of endoscope equipment
EN
10993-1:2003
Biological evaluation of medical
devices, Part 1: Evaluation and
Testing Third Edition