AAMI ST24 : 1999 : R2009

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s): Hardcopy, PDF

Superseded date: 09-02-2014

Language(s): English

Published date: 01-01-2013

Publisher: Association for the Advancement of Medical Instrumentation

Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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Committee	WG 62
Document Type	Standard
ISBN
Pages
Product Note	Reconfirmed 2009
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	AAMI ST24 : 1999 : R2013
Supersedes	AAMI ST24 : 1999 : R2005

Standards Referencing This Book - (Show below) - (Hide below)

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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