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AAMI ST81 : 2004 : R2010

Superseded

Superseded

View Superseded by

STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES

Available format(s)

PDF

Language(s)

English

Published date

01-01-2010

Superseded date

11-01-2017

Superseded by

ANSI/AAMI/ISO 17664:2017

US$152.00
Excluding Tax where applicable
Summarise this standard

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 2010
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

⚠

A newer version of this standard is available.

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US$152.00
Excluding Tax where applicable