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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 IPX1 (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

2006/66/EC Battery directive

ISO13485:2003 Quality systems - Medical Devices - Requirements for

regulating purposes

ISO14971:2000+A1:2003 Risk analysis managements – medical devices

IEC60601-1:1988+A1:1991+A2:1995

General requirements for safety of medical electrical equipment

IEC60529:2001 Degree of protection provided by enclosures (IPX1)

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 Collateral standard for medical electrical systems

IEC60601-1-4:2000 Collateral standard for programmable medical systems

IEC60601-1-6:2004 Collateral standard for usability

ISO10993-1:2003 Biological evaluation of medical devices – Part 1: Evaluation

and testing

ISO10993-5:1999 Biological evaluation of medical devices – Part 5: Tests for in

vitro cytotoxicity

ISO10993-10:2002 Biological evaluation of medical devices – Part 10: Tests for

irritation and delayed-type hypersensitivity

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

IEC60601-2-27:2005 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

EN1060-4:2004 Non-invasive sphygmomanometers - Test procedures to

determine the overall system accuracy of automated non-invasive

sphygmomanometers

IEC60601-2-30:1999 Particular requirements for the safety, including essential

performance, of automatic cycling indirect blood pressure monitoring equipment

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