AAMI ST81 :2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES
Hardcopy , PDF
01-11-2017
English
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Superseded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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