Regulatory requirements for medical equipment

IEEE Instrumentation and Measurement Magazine

Volumn 6, Issue 4, 2003, Pages 23-29

  Marcus, Michael L ^a   Biersach, Brian R ^b  

^a PENNSYLVANIA STATE UNIVERSITY   (United States)

^b Medical Equip Compliance Assoc LLC

Author keywords

[No Author keywords available]

Indexed keywords

ACCIDENT PREVENTION; BIOCOMPATIBILITY; CODES (STANDARDS); ELECTROMAGNETIC COMPATIBILITY; PRODUCT DESIGN; PRODUCT DEVELOPMENT; REGULATORY COMPLIANCE; REQUIREMENTS ENGINEERING;

PRODUCT SAFETY; REGULATORY REQUIREMENTS; SAFETY CERTIFICATION;

BIOMEDICAL EQUIPMENT;

EID: 0345549560     PISSN: 10946969     EISSN: None     Source Type: Journal    
DOI: 10.1109/MIM.2003.1251479     Document Type: Article

References (5)

1. Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties, U.S. Dept. of Health and Human Services, Feb. 2, 2001.
2. Medical Device Directive, Council Directive 93/42/EEC, June 1993.
3. UL StandardsInfoNet, UL Standards for Safety catalog [Online]. Available: http://ulstandardsinfonet.ul.com/
4. Remainder of Effective Date for Withdrawal of UL544 and UL187. UL Bulletin to Subscribers of UL's Service for Medical Electrical Equipment. Melville, NY: Underwriters Laboratories Inc. May 10, 1999.
5. IEC Web site: http://www.iec.ch/seatop-e.htm