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AAMI ST24 : 1999 : R2005

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
Available format(s)

Hardcopy , PDF

Superseded date

09-01-2021

Language(s)

English

Published date

01-01-2013

Committee representation
Acknowledgment
Foreword
1 Scope
  1.1 General
  1.2 Inclusions
  1.3 Exclusions
2 Normative references
3 Definitions, symbols, and abbreviations
4 Requirements
  4.1 Requirements for EO sterilizers
      4.1.1 Labeling
      4.1.2 Sterilizer construction, components, and
            accessories
      4.1.3 Sterilizer safety
      4.1.4 Process monitoring devices
      4.1.5 Physical performance of sterilizers
      4.1.6 Biological performance of sterilizers
      4.1.7 Certification and recordkeeping
  4.2 Requirements for EO sterilant sources
      4.2.1 Registration
      4.2.2 Labeling
      4.2.3 Container safety
      4.2.4 Product composition
      4.2.5 Shipping
  4.3 Requirements for EO emission control systems
      4.3.1 System approvals
      4.3.2 Labeling
      4.3.3 Performance requirements
      4.3.4 Safety requirements
      4.3.5 Installation requirements
5 Tests
Annexes
A - Rationale for the development and provisions of this
    standard
B - Calculating chamber relative humidity
C - Calculating chamber ethylene oxide concentration
D - Bibliography

Pertains to automatic, general-purpose ethylene oxide (EO) sterilizers and EO sterilant sources that are intended for use in hospitals and other health care facilities.

Committee
WG 62
DocumentType
Standard
Pages
31
ProductNote
Reconfirmed 2005
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
CFR 49(PTS100-177) : OCT 2017 TRANSPORTATION
ASME PV CODE 10 : 2017 BOILER AND PRESSURE VESSEL CODE - FIBER-REINFORCED PLASTIC PRESSURE VESSELS
AAMI ST21 : 2ED 99 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION
NFPA 70 : 2017 NATIONAL ELECTRICAL CODE
ASME PV CODE SET : 2017 BOILER AND PRESSURE VESSEL CODE - COMPLETE SET
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61010-2-042:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes
GG-S-1344 Revision A:0197 STERILIZER, ETHYLENE OXIDE GAS, FOR HEAT- AND MOISTURE-LABILE SURGICAL INSTRUMENTS AND SUPPLIES (NONPORTABLE)

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