Standards and regulations which
apply to this device
Electrical and mechanical safety for
construction and final inspection:
Electromagnetic compatibility:
Software:
Risk management:
Restriction of Hazardous Sub-
stances (RoHS II):
The European directives apply to the
conformity assessment pr
ocess:
Directives for medial devices valid
outside of Eur
ope:
E List of standards
The device is a very high-tech pr
oduct. It is subject to extensive
testing and certication procedures according to the following stand-
ards and regulations in their respectively valid version:
Standard series: IEC 61010 (corresponds to standard series DIN EN
61010)
■ IEC 61010-1 "Safety requirements for electrical equipment for
measur
ement, control, and laboratory use – Part 1: General
requirements" (contamination level 2, overvoltage category II)
■ IEC 61010-2-010 "Safety requirements for electrical equipment
for measur
ement, control, and laboratory use – Part 2-010: Par-
ticular requirements for laboratory equipment for the heating of
materials"
■ IEC 61010-2-011 "Safety requirements for electrical equipment
for measur
ement, control, and laboratory use – Part 2-011: Par-
ticular requirements for refrigerating equipment"
■ IEC 61010-2-101 "Safety requirements for electrical equipment
for measur
ement, control, and laboratory use – Part 2-101: Par-
ticular requirements for in vitro diagnostic (IVD) medical equip-
ment"
EN 61326-1 "Electrical equipment for measurement, control and lab-
oratory use – EMC requirements – Part 1: General requirements"
DIN EN 62304 "Medical device software – Software life cycle pro-
cesses"
DIN EN ISO 14971 "Application of risk management to medical
devices"
EN 50581 "Technical documentation for assessing electric and elec-
tronic devices with regard to the restriction of hazardous substances"
■ Directive 98/79/EC about in-vitro diagnostic devices, EC con-
formity assessment pr
ocess in acc. with Annex III "EC declaration
of conformity" – Self declaration of the manufacturer
■ Directive 2011/65/EU for the restriction of use of certain haz-
ar
dous substances in electric and electronic devices. The EC
conformity assessment process is the sole responsibility of the
manufacturer, without the involvement of a notied body.
■ USA: QSR, 21CFR 820 “CFR T
itle 21 - Food and Drugs: TITLE
21- FOOD AND DRUGS, CHAPTER I - FOOD AND DRUG
ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN
SERVICES, SUBCHAPTER H - MEDICAL DEVICES, Part 820
QUALITY SYSTEM REGULATONS“
■ Canada: CMDR, SOR/98-282 “Medical Devices Regulations”
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