ANSI/AAMI ST90:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES
English
18-07-2017
20-04-2024
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions and abbreviations
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis, and improvement
Annexes
A - Document and record retention
B - Risk management
C - Product quality assurance testing for
steam sterilization in health care
facilities
D - Six major steps in creating a quality
management system
Bibliography
Describes minimum requirements for a quality management system (QMS) in a health care organization to effectively, efficiently, and consistently process medical devices to prevent adverse patient events and non-manufacturer-related device failures.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-676-4
|
| Pages |
50
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| ANSI/AAMI ST91:2021 | Flexible and semi-rigid endoscope processing in health care facilities |
| AAMI ST41 : 2008 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| 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 |
| AAMI ISO TIR 11139 : 2006 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
| ISO 9001:2015 | Quality management systems — Requirements |
| ANSI/AAMI ST79:2017 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
| AAMI/ISO 13485:2016 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
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