Standards for Particular Medical Devices

Device-Specific Standards

Standards with general applicability are on the General Standards page.

(The links on the right lead to the sponsor or publisher.)

Anesthesia Delivery (Gas)

IEC 601-2-13 <> IEC

Apnea Monitor

AAMI TIR-4 <> AAMI

Blood Pressure Monitor

IEC 601-2-34 <> IEC
AAMI SP-10 <> AAMI

Cardiac Defibrillator (External)

IEC 601-2-4 <> IEC
AAMI DF-2 <> AAMI

Cardiac Defibrillator (Automatic External)

AAMI DF-39 <> AAMI

Cardiac Defibrillator (Implanted)

ISO 14994 <> ISO

Cardiac Pacemaker

IEC 601-2-31 <> IEC
ISO-5841-1

Diathermy (RF Therapy) Device

IEC 601-2-3 <> IEC

Electrocardiograph (Monitor)

AAMI EC-38 <> AAMI
AAMI EC-13 <> AAMI

Electroconvulsive Therapy Device

IEC 601-2-14 <> IEC

Electroencephalograph

IEC 601-2-26 <> IEC

Electromyograph

IEC 601-2-40 <> IEC

Electrosurgical Device

IEC 601-2-2 <> IEC
AAMI HF-18 <> AAMI

Evoked Response Stimulator

IEC 601-2-40 <> IEC

Gamma Beam Therapy

IEC 601-2-11 <> IEC

Hearing Aid

ANSI S3.22 <> ANSI

Heating Blankets

IEC 601-2-35 <> IEC

Hospital Bed (Electric Powered)

IEC 601-2-38 <> IEC

Infant Incubator

IEC 601-2-19 <> IEC
IEC 601-2-20 IEC
IEC 601-2-21 IEC
AAMI II-51 <> AAMI

Intracranial Pressure Monitor

ANSI/AAMI NS-28 <> AAMI

Laser Device, Diagnostic and Therapeutic

IEC 601-2-22 <> IEC

Lithotripsy (Ultrasonic)

IEC 601-2-36 <> IEC

Magnetic Resonance Imaging

IEC 601-2-33 <> IEC
NEMA MS <> NEMA

Microwave Therapy

IEC 601-2-6 <> IEC

Nerve Conduction Velocity Measurement Device

IEC 601-2-40 <> IEC

Gamma Beam Therapy

IEC 601-2-11 <> IEC

Nystagmograph

ASA S3-45 <> ASA

Nuclear Imaging Devices

NEMA NU <> NEMA

Peripheral Nerve Stimulator (Implanted)

ANSI/AAMI NS-15 <> AAMI

Radiation Therapy Electron Accelerator

IEC 601-2-1 <> IEC

Radiotherapy Dosimeter

IEC 601-2-9 <> IEC

Spinal Cord Stimulator (Implanted)

ANSI/AAMI NS-14 <> AAMI

Transcutaneous Electrical Nerve Stimulator

ANSI/AAMI NS-4 <> AAMI

Ultrasound Imaging

AIUM SMP Methods for Measuring Performance <> AIUM
NEMA UD <> NEMA

Ventilator

IEC 601-2-12 <> IEC

Wheelchair

ISO 7176 <> ISO
ANSI/RESNI WC <> RESNA

X-Ray Equipment, Diagnostic

IEC 601-2-7 <> IEC
NEMA XR <> NEMA