NEMA/MITA 1:2015
Current
The latest, up-to-date edition.
Good Refurbishment Practices for Medical Imaging Equipment
Hardcopy , PDF
English
22-02-2016
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
This standard describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoring of used medical imaging equipment to a condition of safety and effectiveness comparable to that of new equipment.
| 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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