Medical Device Standards Data

Desig.: AAMI BP-22 Org.: AAMI

Developer/Committee:

Title: Blood Pressure Transducers

Status: published 1994, reaffirmation proposed

Scope:

Member Comments:

Desig.: AAMI SP-9 Org.: AAMI

Developer/Committee:

Title: Non-Automated Sphygmomanoneters

Status: amended, Nov. 1996

Scope:

Member Comments:

Desig.: AAMI SP-10 Org.: AAMI

Developer/Committee:

Title: Electronic or Automated Sphygmomanoneters

Status: published 1991, Amendment 1, 1996, 3rd Edition begun
Scope:

Member Comments:

Desig.: AAMI TIR-9 Org.: AAMI

Developer/Committee:

Title: Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring

Status: published 1992

Scope:

Member Comments:

Desig.: ISO 5841-1 Org.: ISO

Developer/Committee: ISO TC150/SC6/WG2 N8

Title: Cardiac Pacemakers -- Part 1: Implantable Pacemakers

Status: Dec. 2000, redrafting, next meeting Apr. 2001, New York

Scope:

Member Comments: Implanted defibrillators also being considered

Desig.: AAMI EC-38 Org.: AAMI

Developer/Committee: AAMI

Title: Ambulatory Electrocardiographs


Status: ANSI approved, Draft revision balloted by AAMI Jan. 1998

Scope:

Member Comments:

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Desig.: IEC 601-2-14 Org.: AAMI

Developer/Committee: SC 62D
Title: Part 2: Particular Requirements for the safety of electroconvulsive therapy equipment

Status: publ. 1989: AAMI balloting for withdrawal; other options: continue or revise

Scope: Safety provisions for ECT devices: switch design, energy limits, etc.

Member Comments:

Desig.: IEC 601-2-40 Org.: AAMI

Developer/Committee: AAMI TAG for SC 62D

Title: Part 2: Particular Requirements for the safety of electromyographs and evoked response equipment


Status: FDIS: AAMI Balloting

Scope: Intended for brainstem evoked response electrical, photic and sonic stimulators; EMG recording devices.

Member Comments:

Desig.: AAMI NS-28 Org.: AAMI

Developer/Committee: AAMI Neurosurgery

Title: Standard for Intracranial Pressure Monitoring Devices


Status: ANSI reaffirmed 1993

Scope:

Member Comments:

Desig.: AAMI NS-4 Org.: AAMI

Developer/Committee: AAMI Neurosurgery

Title: Standard for Transcutaneous Electrical Nerve Stimulators


Status: ANSI approved 1985

Scope:

Member Comments: Revision that includes muscle stimulators is being drafted

Desig.: AAMI NS-15 Org.: AAMI

Developer/Committee: AAMI Neurosurgery

Title: Standard for Implantable Peripheral Nerve Stimulators


Status: ANSI approved 1984

Scope:

Member Comments:

Desig.: AAMI NS-14 Org.: AAMI

Developer/Committee: AAMI Neurosurgery

Title: Standard for Implantable Spinal Cord Stimulators


Status: ANSI approved 1984

Scope:

Member Comments:

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Desig.: IEEE 1073 Org.: IEEE

Developer/Committee:

Title: Medical Device Communications-Overview and Framework

Status: published 1996

Scope:

Member Comments:

Desig.: IEEE 1073.1

Title: Medical Device Communications-Medical Device Data Language (MDDL) Overview

Status: project approved

Scope:

Member Comments:

Desig.: IEEE 1073.1.1

Title: MDDL -- Common Definitions

Status: project approved

Scope:

Member Comments:

Desig.: IEEE 1073.1.2

Title: MDDL -- Virtual Medical Device Generalized

Status: project approved

Scope:

Member Comments:

Desig.: IEEE 1073.1.3.1

Title: MDDL -- Medical Device Specializations -- Infusion Device

Status: project approved

Scope: Defines communications model for volumetric infusion devices, syringe infusion devices, and feeding pumps.

Member Comments:

Desig.: IEEE 1073.1.3.2

Title: MDDL -- Medical Device Specializations -- Vital Signs Monitor

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.3

Title: MDDL -- Medical Device Specializations -- Ventilator

Status: project approved

Scope: Defines communications model for ventilators.

Member Comments:

Desig.: IEEE 1073.1.3.4

Title: MDDL -- Medical Device Specializations -- Pulse Oximeter.

Status: project approved

Scope: Defines communications model Member Comments:

Desig.: IEEE 1073.1.3.5

Title: MDDL -- Medical Device Specializations -- Defibrillator

Status: Project approved

Scope: Defines communications model

Member Comments:

Desig.:

Desig.: IEEE 1073.1.3.6

Title: MDDL -- Medical Device Specializations -- ECG

Status: project approved

Scope: Defines communications model for ECG.

Member Comments:

Desig.: IEEE 1073.1.3.7

Title: MDDL -- Medical Device Specializations -- Blood Pressure

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.8

Title: MDDL -- Medical Device Specializations -- Temperature

Status: project approved

Scope: Defines communications model for Temperature.

Member Comments:

Desig.: IEEE 1073.1.3.9

Title: MDDL -- Medical Device Specializations -- Airway Flowmeter

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.10

Title: MDDL -- Medical Device Specializations -- Cardiac Output

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.11

Title: MDDL -- Medical Device Specializations -- Capnometer

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.12

Title: MDDL -- Medical Device Specializations -- Hemodynamic Calculator

Status: project approved

Scope: Defines communications model for Hemodynamic Calculator.

Member Comments:

Desig.: IEEE 1073.1.3.13

Title: MDDL -- Medical Device Specializations -- Pulmonary Calculator

Status: project approved

Scope: Defines communications model for Pulmonary Calculator.

Member Comments:

Desig.: IEEE 1073.1.3.14

Title: MDDL -- Medical Device Specializations -- Respirator

Status: project approved

Scope: Defines communications model for .

Member Comments:

Desig.: IEEE 1073.1.3.15

Title: MDDL -- Medical Device Specializations -- Scale

Status: project approved

Scope: Defines communications model for .

Member Comments:

IEEE 1073.2

Title: Medical Device Communications -- Applications Profiles (MDAP) Framework&Overview

mall>Status: draft, Sept. '95

Scope:

Member Comments:

Desig.: IEEE 1073.3.1

Title: Medical Device Communications -- Transport Profile -- Connection Mode

Status: published 1994, amended 2000 (1073.3.1a,amendment 1

Scope:

Member Comments:

Desig.: IEEE 1073.3.3

Title: Medical Device Communications -- Transport Profile -- IrDA Based -- Infrared Wireless

Status: Proposed Feb.2001

Scope:

Member Comments:

Desig.: IEEE 1073.4.1

Title: Medical Device Communications -- Physical Layer Interface -- Cable Connected

Status: published 1994, revised 2000

Scope:

Member Comments:

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Desig.: IEEE 1073.5

Title: Medical Device Communications -- Internetworking

Status: project approved

Scope:

Member Comments:

Desig.: IEEE 1157 Org.: IEEE

Developer/Committee:

Title: Standard for Healthcare Data Interchange -- Overview and Framework

Status: project withdrawn

Scope: Defines the conceptual frame for standardization of healthcare data interchange in terms of a healthcare information model, healthcare data interchange formats, and standardized profiles for ISO/OSI communication protocols. This document also defines a document architecture for the framework. The scope of the framework is standardization of healthcare data interchange in the open systems environment.

Member Comments:

Desig.: ISO 7176-1 Org.: ISO

Developer/Committee:

Title: Wheelchairs -- Part 1: Determination of Static Stability


Status:

Scope:

Member Comments:

Desig.: ISO 7176-2
Title: Wheelchairs -- Part 2: Determination of Dynamic Stability of Electric
Status:
Desig.: ISO 7176-3
Title: Wheelchairs -- Part 3: Determination of Efficiency of Brakes
Status:
Desig.: ISO 7176-4
Title: Wheelchairs -- Part 4: Determination of Energy Consumption of Electric Wheelchairs and Scooters for Determination of Theoretical Distance Range
Status:
Desig.: ISO 7176-5
Title: Wheelchairs -- Part 5: Determination of Overall Dimensions, Mass, and Turning Space
Status:
Desig.: ISO 7176-6
Title: Wheelchairs -- Part 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs
Status:
Desig.: ISO 7176-9
Title: Wheelchairs -- Part 9: Climatic Tests for Electric Wheelchairs
Status:
Desig.: ISO 7176-10
Title: Wheelchairs -- Part 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs
Status:
Desig.: ISO 7176-11
Title: Wheelchairs -- Part 11: Test Dummies
Status:
Desig.: ISO 7176-13
Title: Wheelchairs -- Part 13: Determination of Coefficient of Friction of Test Surfaces
Status:
Desig.: ISO 7176-14
Title: Wheelchairs -- Part 14: Power and Control Systems for Electric Wheelchairs -- Requirements and Test Methods
Status:
Desig.: ISO 7176-15
Title: Wheelchairs -- Part 15: Requirement for Information Disclosure, Documentation and Labeling
Status:
Desig.: ISO 7176-16
Title: Wheelchairs -- Part 16: Resistance to Ignition of Upholstered Parts -- Requirements and Test Methods
Status:
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Desig.: RESNA WC/01 Org.: RESNA

Developer/Committee:

Title: WC/01 Determination of Static Stability

Status:

Scope:

Member Comments:

Title: WC/02 Determination of Dynamic Stability of Electric Wheelchairs
Status:

Scope:

Member Comments:

Title: WC/03 Determination of Effectiveness of Brakes
Status:

Scope:

Member Comments:

Title: WC/04 Determination of Energy Consumption of Electric Wheelchairs
Status:

Scope:

Member Comments:

Title: WC/05 Determination of Overall Dimensions, Mass, and Turning Space
Status:

Scope:

Member Comments:

Title: WC/06 Determination of Maximum Speed, Acceleration, and Retardation
Status:

Scope:

Member Comments:

Title: WC/07 Determination of Seating and Wheel Dimensions
Status:

Scope:

Member Comments:

Title: WC/08 Static, Impact and Fatigue Strength Tests
Status:

Scope:

Member Comments:

Title: WC/09 Climatic Tests
Status:

Scope:

Member Comments:

Title: WC/10 Determination of Obstacle-Climbing Ability
Status:

Scope:

Member Comments:

Title: WC/11 Test Dummies
Status:

Scope:

Member Comments:

Title: WC/12 Coefficient of Friction of Test Surfaces
Status:

Scope:

Member Comments:

Title: WC/13 Testing of Power and Control Systems
Status:

Scope:

Member Comments:

Title: WC/14 Requirement for Documentation
Status:

Scope:

Member Comments:

Title: WC/15 Determination of Flammability
Status:

Scope:

Member Comments:

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Desig.: NEMA MS 1 Org.: NEMA

Developer/Committee:

Title: Determination of Signal to Noise Ratio in Magentic Resonance Images


Status:

Scope:

Member Comments:

Desig.: NEMA MS 2
Title: Determination of Two Dimensional Geometric Distortion ...

Status:

Desig.: NEMA MS 3
Title: Determination of Image Uniformity ...

Status:

Desig.: NEMA MS 4
Title: Acoustic Noise Measurement Procedure ...

Status:

Desig.: NEMA MS 5
Title: Determination of Slice Thickness ...

Status:

Desig.: NEMA MS 6
Title: Characterization of Special Purpose Coils ...

Status:

Desig.: NEMA MS 7
Title: Measurement Procedure for Time-Varying Gradient Fields (dB/Dt) ...

Status:

Desig.: NEMA MS 8
Title: Characterization of Specific Absorption Rate ...

Status:

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Desig.: NEMA NU 1 Org.: NEMA

Title: Performance Measurements for Scintillation Cameras

Status:

Scope:

Member Comments:

Desig.: NEMA NU 2
Title: Performance Measurements of Positron Emission Tomographs

Status:

Scope:

Member Comments:

Desig.: NEMA UD 2 Org.: NEMA

Title: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment

Status:

Scope:

Member Comments:

Desig.: NEMA UD 3
Title: Standard for Real Time-Display of Thermal and Mechanical Acoustic Indices on ...

Status:

Desig.: NEMA XR 5 Org.: NEMA

Title: Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray Tubes

Status:

Scope:

Member Comments:

Desig.: NEMA XR 10
Title: Measurement of Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube...

Status:

Desig.: NEMA XR 11
Title: Test Standard for Determination of the Limiting Spatial Resolutions of X-Ray Image Intensifier Systems

Status:

Desig.: NEMA XR 15
Title: Test Standard for the Determination of the Visible Entrance Field Size of an X-Ray Image Intensifier System

Status:

Desig.: NEMA XR 16
Title: Test Standard for the Determination of the System Contrast Ratio and the System Veiling Glare Index of ...

Status:

Desig.: NEMA XR 17
Title: Test Standard for the Measurement of Image Signal Uniformity of ...

Status:

Desig.: NEMA XR 18
Title: Test Standard for the Determination of the Radial Image Distortion of ...

Status:

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copyright © 2003

r.munzner@ieee.org ...comments & corrections are appreciated.
revised June 1, 2003