Colin BP-S510, Руководство по эксплуатации

Страница: 133 / 137

127
Compliance
Item Compliant with
Classification Class I (on AC power) Internally powered (on battery power)
Type of protection Type CF – Applied part
Mode of operation Continuous
Degree of protection IP21 (provided by enclosures)
General 93/42/EEC Directives for medical devices
21CFR820 Code of Federal Regulations
2002/96/EC Waste electrical and electronic equipment Directive(WEEE)
91/157/EEC Battery Declaration Directive
93/86/EEC Battery Disposal Directive
ISO9001:2000 Quality Management Systems - Requirements
ISO13485:1996 Quality Systems– Medical Devices –Particular requirements
for the application of ISO9001
ISO14971:2000 Risk analysis managements – medical devices
IEC60601-1:1988+A1:1991+A2:1995
General requirements for Safety and Essential Performance
IEC60529:2001 Degree of Protection Provided by Enclosures (IP21)
EN ISO14155-1:2003 Clinical investigation of medical devices for human
subjects – part 1: General requirements
AAMI HE48:1993 Human factors engineering guidelines and preferred
practices for the design of medical devices
IEC60601-1-1:2000 Safety requirements for medical electrical systems
IEC60601-1-4:2000
Particular requirements for programmable medical systems
IEC60601-1-6:2004 Medical electrical equipment Part 1-6: General
requirements for safety Collateral Standard: Usability
ISO10993-1:2003 Biological evaluation of medical devices – Part 1:
Evaluation and testing
IEC60601-2-49:2001
Particular requirements for multifunction patient monitoring equipment
Alarms
IEC60601-1-8:2003 Alarm systems requirements, tests and guidances in
medical electrical equipments systems
Electrocardiograph
IEC60601-2-27:1994 Particular requirements for the safety of
Electrocardiographic monitoring equipment
AAMI EC13:2002 Cardiac monitors, heart rate meters and alarms
AAMI EC53:1995+A1:1998 ECG cable and leads
AAMI SP10:2002+A1:2003 Electronic or Automated Sphygmomanometers
Non-invasive blood
pressure
EN1060-1:1995+A1:2002 Non-invasive sphygmomanometers
EN1060-3:1997 Supplementary requirements for electrical-mechanical blood
pressure measuring systems
IEC60601-2-30:1999 Particular requirements for the Safety, including
essential performance, of automatic cycling indirect blood pressure monitoring
equipment
Oxygen saturation EN865:1997 Pulse oximeters, Particular requirements
ISO9919:2005 Basic safety & essential performance of Pulse oximeter for
medical use
Temperature
monitoring EN12470-4:2000
Performance of Electrical Thermometers for continuous Measurement