AAMI ST24 : 1999 : R2005
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
Hardcopy , PDF
01-09-2021
English
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Superseded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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