Vatech Pax-i PCH-2500, Installation Manual

Page: 12 / 200

PaX-i
(PCH-2500) Installation Manual
12
Notice to the Installers
This equipment complies with the following standards:
Installation and operation of this equipment comply with the following standards:
IEC 60601-1: General requirements for safety
IEC60601-1-1: General requirements for safety - Collateral standard: Safety
requirements for medical electrical systems
IEC 60601-1-2: General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic
IEC 60601-1-3: General requirements for safety - Collateral standard: General
requirements for radiation protection in diagnostic X-ray equipment
IEC60601-2-7 and IEC60601-2-28: Requirements for the safety of high-voltage
generators of diagnostic X-ray generators / Particular requirements for the safety
of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-32: Requirements for the safety of associated equipment of X-ray
equipment
IEC 60950-1: 2nd edition: Standards for Information Technology Equipment
IEC60364-7-710: Local Code Requirements for Electro-Medical System
Installation
1. IEC 60601-1: regulations must be fully met to ensure the safety of patients,
operators and the environment when any person assembles or modifies a
medical electrical system or combines it with other equipment.
2. Any equipment not provided by VATECH must be connected in compliance
with the following standards: IEC 60950-1 and IEC 60601-1 .
3. The electrical installation of this equipment must comply with local code
requirements for electro-medical systems: IEC 60364-7-710 .