NEMA/MITA 1:2015
Current
The latest, up-to-date edition.
Good Refurbishment Practices for Medical Imaging Equipment
Hardcopy , PDF
English
22-02-2016
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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 |
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