Applicable Standards - CPI CMP 200 Series Service Manual

1
Pre-installation
1.1.5

Applicable Standards

The CMP 200® / CMP 200® DR series of X-ray generators comply with the regulatory requirements and
design standards in this section as follows:
•
VZW2555 series: Only the standards marked with an asterisk
•
VZW2556 series: All standards in this section.
A) SAFETY
• *
FDA Center for Devices & Radiological Health (CDRH) - 21 CFR title 21 subchapter J (USA).
• *
Radiation Emitting Devices Act - C34 (Canada).
•
Medical Device Regulations (Canada).
•
EC Directive 93/42/EEC concerning Medical Devices (European Community).
•
*
EN 60601-1/IEC 60601-1, EN 60601-2-7/IEC 60601-2-7, CSA 601.1, UL60601.1.
-Type of protection against electric shock: Class I equipment.
-Degree of protection against electric shock: Not classified.
-Degree of protection against harmful ingress of water: Ordinary equipment.
-Mode of operation: Continuous operation with intermittent loading (standby - exposure).
-Equipment not suitable for use in presence of a flammable anesthetic mixture with air or
with oxygen or nitrous oxide.
•
EN 60601-1-4/IEC 60601-1-4, EN ISO 14971, EN 60601-1-6/IEC 60601-1-6
**
This standard applies only to X-ray generators with a CPI-supplied operator's console. It does not
apply to "smart power supplies" in which the OEM or integrator supplies the operator's console.
NOTE: All referenced standards are considered to be at the latest adopted revision.
Use and disclosure is subject to the restrictions on the title page of this CPI document.
Page 1-4
The CE Mark is a declaration by the manufacturer that the product complies with
the requirements of the applicable European Union (EU) medical device directive
and that the product has been subject to conformity assessment procedures as
provided in that directive.
A CSA mark with the indicators "C" and "US" means that product is certified for
both the U.S. and Canadian markets, to the applicable U.S. and Canadian
standards.
®
CMP 200 X-Ray Generator Service Manual
*
under SAFETY.
**
.
Ch # 901476-01
CPI Canada Inc.
Rev. C