AAMI TIR14 : 2016

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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CONTRACT STERILIZATION USING ETHYLENE OXIDE

Available format(s): Hardcopy, PDF

Superseded date: 16-02-2023

Language(s): English

Published date: 05-06-2016

Publisher: Association for the Advancement of Medical Instrumentation

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

Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Definitions
3 Selection of sterilization facility
4 Written agreement between product manufacturer and
contract sterilizer
5 Validation program
6 Handling of BIs, PCDs, and product samples
7 Sterilization processing documentation
8 Controls for routine processing
Bibliography

Abstract - (Show below) - (Hide below)

Gives guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations.

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Development Note	Formerly it was AAMI ST27 (05/2001)
Document Type	Standard
ISBN
Pages
Published
Publisher	Association for the Advancement of Medical Instrumentation
Status	Superseded
Superseded By	AAMI TIR14:2016(R2020)
Supersedes	AAMI TIR14 : 2009 AAMI ST27 : 1988

Standards Referenced By This Book - (Show below) - (Hide below)

AAMI TIR16 : 2017	MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
AAMI TIR15 : 2016	PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
AAMI TIR28 : 2016	PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION

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

ANSI/AAMI/ISO 10993-3:2014	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
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 40(PTS61-71) : JUL 96	PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
CFR 21(PTS800-1299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
AAMI ISO TIR 11139 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY
AAMI TIR28 : 2016	PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION
ANSI/AAMI/ISO 11138-2:2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
AAMI ISO 14161 : 2009	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
CFR 29(PT1910.1000 TO END) : 0	LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
CFR 40(PTS1-49) : JUL 2017	PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
ANSI/AAMI/ISO 11138-1:2017	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
ANSI/AAMI/ISO 10993-12:2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ANSI/AAMI/ISO 10993-6:2016	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
AAMI/ISO 13485:2016	MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
AAMI ISO 10993-4 : 2002	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD

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