This site includesthe following cross-linked pages:
General Standards//
Particular Standards//
Standards Organizations//
Standards Notes
These pages are intended to summarize the activities and documents of the various standards development organizations applicable to the design of electronic
medical devices.
Standards that apply to particular devices are on
another page.
The links on the right lead to the sponsoring organization or publisher.
Links on the left, if present, lead to descriptive information and IEEE/EMBS member notations.
Electrical Safety
Ionizing Radiation Safety
Microwave and RF Energy Safety
Light Emission and Laser Safety
Sound and Ultrasound Emission Safety
Electromagnetic (RF) Compatibility
- IEC60601-1-2 <> IEC
- IEC60601-1-2 Draft #2
- ANSI 63.4 Emission measurement (9 KHz to 40 GHz) <>
ANSI
- ANSI 63.5 Antenna Calibration Method
- ANSI 63.18 draft #7 Ad-hoc Test Method (for RF immunity)
Software Safety & Reliability
- ANSI/AIAA R-013 Reliability <> ANSI
- ANSI/ANS-10.4 Validation
- IEC60601-1-4 Programmable Electrical Medical Systems <>
IEC
- IEEE 730 Quality Assurance Plans <> IEEE
- IEEE Configuration Management Plans
- IEEE 830 Specifications
- IEEE 1008 Unit Testing
- IEEE 1012 Verification and Validation Plans
- IEEE 1042 Configuration Management
- IEEE 1228 Safety Plans
- ISO 9000-3 Quality Management and Assurance <>
ISO
- ISO 12119 Quality Requirements & Testing
- UL 1998 Safety Related Standard <>
UL
Computer Interface Compatability
- IEEE 1073 Medical Device (Digital) Communications <>
IEEE1073
- IEEE 1532 In System Configuration of Programmable Devices
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copyright © 2003
r.munzner@ieee.org
www.DoctorDevice.com...comments & corrections are appreciated.
revised Sept. 31, 2003