ISO/IEC 17025 technical requirements in electrical safety laboratory for electromedical devices

Author

Rubio, Débora ; Ponce, Sergio ; Madrid, Francisco

Author_Institution

LEDIB Lab. de ensayo de dispositivos biomedicos, UTN, San Nicolas, Argentina

fYear

2011

fDate

March 28 2011-April 1 2011

Firstpage

222

Lastpage

222

Abstract

The implementation of a research laboratory for the electrical security of electromedical equipment requires of the study of the ISO/IEC 17025 standard “General competency requirements for calibration and research laboratories”. The fulfilment of these requirements, establishing a quality program, guarantees that the laboratory is organized under a management system, with enabled personnel, approved and validated methods, assuring technical aptitude, data handling and results. The objective of the present work is to describe the technical aspects that were considered for the implementation of our research laboratory, fulfilling ISO/IEC standard 17025.

Keywords

IEC standards; ISO standards; biomedical equipment; laboratory techniques; safety; IEC 17025 technical requirements; ISO technical requirements; electrical safety laboratory; electromedical devices; Conferences; Couplings; Electrical safety; IEC standards; ISO standards; Laboratories; Medical services; Biomedical devices; testing laboratories;

fLanguage

English

Publisher

ieee

Conference_Titel

Health Care Exchanges (PAHCE), 2011 Pan American

Conference_Location

Rio de Janeiro

Print_ISBN

978-1-61284-915-7

Type

conf

DOI

10.1109/PAHCE.2011.5871888

Filename

5871888