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ANSI/AAMI ST90:2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by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

Available format(s)

Hardcopy , PDF

Superseded date

20-04-2024

Language(s)

English

Published date

18-07-2017

€231.51
Excluding VAT

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Superseded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

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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