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Technical Information

105

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 — Hu-

man factors engineering guidelines and preferred practices for

the design of medical devices. (February 5, 1988 version) De-

sign guideline.

ENV 50204 (1995) - Radiated electromagnetic field from digi-

tal radio telephone — Immunity test

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 sys-

tems. Amendment 1 (1995)

IEC 60601-1-2 (1993) - General Requirements for Safety, Part

2 — Electromagnetic compatibility — Requirements and tests.

(European Harmonized Standard)

IEC 60601-1-2 (2nd Edition, 01 June 1996, Committee

Draft) - Medical Electrical Equipment, Part 1: General require-

ments for safety. 2. Collateral standard: Electromagnetic com-

patibility — Requirements and tests

IEC 60601-1-4 (1996) - Medical Electrical Equipment, Part

1: General requirements for safety — 4. Collateral standard:

Programmable 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 elec-

trical equipment in medical practice

IEC 61000-4-2 (1995) - Electromagnetic Compatibility

(EMC), Part 4: Testing and measurement techniques. Section

2: Electrostatic Discharge immunity test. Basic EMC Publica-

tion.

IEC 61000-4-3 (1995) - Electromagnetic Compatibility (EMC,

Part 4: Testing and measurement techniques. Section 3: Radi-

ated, radio frequency, electromagnetic fields 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 field immunity test, 1993

CISPR11 (1990) - Limits and methods of measurement of

electromagnetic disturbance characteristics of industrial, sci-

entific and medical (ISM) radio frequency equipment. Amend-

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