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AAMI ST8-2008 Hospital Steam Sterilizers

Standard Number:  AAMI ST8-2008
Title:  Hospital Steam Sterilizers
Language:  English
Replaced by Standard:  AAMI ST8:2013

Replacing Standard:  AAMI ST8 Ed. 4 (2001)

Status:  Withdrawn
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Sterilization and disinfection
Publisher:  Other Standards
Price:  
Number of Pages:42  

Description:Pertains to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (2 cubic feet [ft[3]]).  
Catalog:Glossary of equivalent standards
Committee representation
Acknowledgments
Foreword
1 Scope
1.1 General
1.2 Inclusions
1.3 Exclusions
2 Normative references
3 Definitions, symbols, and abbreviations
4 Requirements
4.1 Labeling
4.1.1 Device markings
4.1.2 Information manual
4.1.3 Service manual
4.2 Sterilizer design, construction, components,
and accessories
4.2.1 Pressure requirements
4.2.2 Pressure vessel certification
4.2.3 Electrical components
4.2.4 Corrosion resistance
4.2.5 Air filters
4.3 Sterilizer safety
4.3.1 Interlock
4.3.2 Prevention of thermal hazards
4.3.3 Sterilizer controls for aborting cycles
4.4 Process monitoring and control devices
4.4.1 General
4.4.2 Chamber temperature
4.4.3 Thermometric test connection
4.4.4 Sterilizer exposure timer
4.4.5 Pressure measurement
4.4.6 Cycle documentation
4.5 Biological performance of sterilizers
4.6 Mechanical air removal
4.6.1 Air removal (dynamic-air-removal sterilizers)
4.6.2 Air leaks (prevacuum sterilizers)
4.7 Sterilizer performance certification and
recordkeeping
5 Tests
5.1 Labeling
5.2 Sterilizer design, construction, components, and
accessories
5.2.1 Pressure requirements
5.2.2 Pressure vessel certification
5.2.3 Electrical components
5.2.4 Corrosion resistance
5.2.5 Air filters
5.3 Sterilizer safety
5.3.1 Interlock
5.3.2 Prevention of thermal hazards
5.3.3 Sterilizer controls for aborting cycles
5.4 Process monitoring and control devices
5.4.1 General
5.4.2 Chamber temperature
5.4.3 Thermometric test connection
5.4.4 Sterilizer exposure timer
5.4.5 Pressure measurement
5.4.6 Cycle documentation
5.5 Biological performance of sterilizers
5.5.1 General testing requirements
5.5.2 Biological performance with a fabric PCD
5.5.3 Biological performance with liquid loads
(if applicable)
5.5.4 Biological performance with wrapped
instrument PCD
5.5.5 Biological performance of abbreviated
(flash) cycles for single-wrapped or unwrapped
nonporous items
5.6 Mechanical air removal tests
5.6.1 Air removal test (dynamic-air-removal
sterilizers)
5.6.2 Air leak-rate test (prevacuum sterilizers)
5.7 Sterilizer performance certification and
recordkeeping
Annexes
A - Rationale for the development and provisions of this
standard
B - Examples of cycle documentation
C - Bibliography  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  659KB
Tile in English:  Hospital Steam Sterilizers

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