Good Refurbishment Practices for Medical Imaging Equipment

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-22-2016

Publisher

National Electrical Manufacturers Association

Foreword
Introduction
Section 1 - GENERAL
Section 2 - SCOPE
Section 3 - NORMATIVE REFERENCES
Section 4 - TERMS AND DEFINITIONS
Section 5 - GENERAL REQUIREMENTS FOR
REFURBISHMENT OF USED MEDICAL DEVICES
Section 6 - SPECIFIC REQUIREMENTS FOR GOOD
REFURBISHMENT PRACTICE

Lays out the basic requirements for a refurbishment process for medical electrical equipment which will not change the equipment’s original intended use, safety profile, or performance.

DocumentType	Standard
Pages	17
PublisherName	National Electrical Manufacturers Association
Status	Current

IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
IEC 62353:2014	Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
ISO 14971:2007	Medical devices Application of risk management to medical devices