Technical Information
63
Pump development
standards
AAMI ID26: 1998 - Medical Electrical Equipment — Part 2:
Particular requirements for the safety of infusion pumps and
controllers.
ANSI/AAMI HE48: 1993 - Recommended Practice — Human
factors engineering guidelines and preferred practices for the
design of medical devices. (February 5, 1988 version) Design
guideline.
IEC 60601-1 (Second Edition, 1988) - Medical Electrical
Equipment, Part 1: General requirements for safety. Amend-
ment 1 (1991), Amendment 2 (1995).
IEC 60601-1-1 (Second Edition, 1992) - Medical Electrical
Equipment, Part 1: General requirements for safety - 1. Collat-
eral standard: Safety requirements for medical electrical systems.
Amendment 1 (1995).
IEC 60601-1-2 (2001) - General Requirements for Safety, Part 2
— Electromagnetic compatibility — Requirements and tests.
(European Harmonized Standard).
IEC 60601-1-4 (1996) - Medical Electrical Equipment, Part 1:
General requirements for safety — 4. Collateral standard: Pro-
grammable electrical medical systems.
IEC 60601-2-24 (1998-02) - Medical Electrical Equipment,
Part 2–24: Particular requirements for safety of infusion pumps
and controllers.
IEC 878 (First Edition, 1988) - Graphical symbols for electrical
equipment in medical practice.
IEC 61000-4-2 (1995) - Electromagnetic Compatibility (EMC),
Part 4: Testing and measurement techniques. Section 2: Electro-
static Discharge immunity test. Basic EMC Publication.
IEC 61000-4-3 (1995) - Electromagnetic Compatibility (EMC,
Part 4: Testing and measurement techniques. Section 3: Radi-
ated, radio frequency, electromagnetic elds immunity test.
Basic EMC Publication. Amendment 1 (1998-06).
IEC 61000-4-8 (1993) - Electromagnetic Compatibility (EMC),
Part 4: Testing and measurement techniques, Section 8: Power
frequency magnetic eld immunity test, 1993.
CISPR11 (1990) - Limits and methods of measurement of elec-
tromagnetic disturbance characteristics of industrial, scientic
and medical (ISM) radio frequency equipment. Amendment 1
(1996; Amendment 2 (1996).
CISPR14 (1993) - International Special Committee on Radio
Interference, limits and methods of measurement of radio
interference characteristics of household electrical appliances,
portable tools and similar electrical apparatus. Amendment 1
(1996).
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