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AAMI ST81 :2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

11-01-2017

Language(s)

English

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be provided by the
  medical device manufacturer
4 Presentation of the information
5 Validation of the reprocessing
  information provided
6 Risk analysis
Annexes
A - Commonly utilized reprocessing methods
B - An example of reprocessing instructions
    for reusable medical devices
C - Bibliography
D - Background of the development of
    ANSI/AAMI ST81 and rationale for
    national deviations to EN ISO 17664

Describes the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor.

DocumentType
Standard
Pages
29
ProductNote
Reconfirmed 2004
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15223:2000 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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