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AAMI TIR14 : 2016

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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CONTRACT STERILIZATION USING ETHYLENE OXIDE

Available format(s)

Hardcopy , PDF

Superseded date

02-16-2023

Language(s)

English

Published date

06-05-2016

Publisher

Association for the Advancement of Medical Instrumentation

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

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

DevelopmentNote
Formerly it was AAMI ST27 (05/2001)
DocumentType
Standard
ISBN
1-57020-613-9
Pages
19
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

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

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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Hardcopy - English
PDF - English - DRM
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