AAMI TIR15 : 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Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
Available format(s)
Hardcopy , PDF
Superseded date
16-02-2023
Superseded by
Language(s)
English
Published date
18-11-2016
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Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Definitions
3 EO sterilization processing equipment
4 Determination of minimum product
temperature prior to preconditioning
5 Calculation of moisture content
6 Calculation of EO concentration
7 Calculations for use of flammability
curve
8 Guide for statistical comparison to
determine process equivalence
Bibliography
Gives additional guidance to augment ANSI/AAMI/ISO 11135:2014.
| DevelopmentNote |
Formerly it was AAMI ST27 (05/2001)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-653-5
|
| Pages |
37
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| DD CEN ISO/TS 11135-2:2008 | Sterilization of health care products. Ethylene oxide Guidance on the application of ISO 11135-1 |
| DIN EN ISO 11135:2014-10 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| CSA Z11135-2 : 2009 : FR | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| CSA Z11135 : 2015 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 11135:2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014) |
| S.R. CEN ISO/TS 16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014) |
| CAN/CSA-ISO/TS 16775:17 | Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15) |
| 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 |
| CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014) |
| PD CEN ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 11/30244091 DC : 0 | BS EN ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| EN ISO 11135:2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| UNI CEN ISO/TS 11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| AAMI TIR16 : 2017 | MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| CSA Z11135-2 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| UNE-EN ISO 11135:2015 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| UNI EN ISO 11135 : 2014 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO/TS 16775:2014 | Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| ISO/TS 11135-2:2008 | Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
| UNI CEN ISO/TS 16775 : 2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| PREN ISO 11135 : DRAFT 2011 | STERILIZATION OF HEALTH-CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO/DIS 11135:2011) |
| AAMI TIR20 : 2001 | PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |
| CSA Z11135-2 : 2009 : R2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| BS EN ISO 11135:2014 | Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices |
| S.R. CEN ISO TS 11135-2:2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
| AAMI ISO TIR 11135-2 : 2008 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1 |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| 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 |
| IEC 61000-6-2:2016 | Electromagnetic compatibility (EMC) - Part 6-2: Generic standards - Immunity standard for industrial environments |
| CFR 21(PTS170-199) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 170-199 |
| CFR 40(PT63) : JUL 98 | NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR SOURCE CATEGORIES |
| 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 |
| CFR 49(PTS100-177) : OCT 2017 | TRANSPORTATION |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| IEC 61000-6-3:2006+AMD1:2010 CSV | Electromagnetic compatibility (EMC) - Part 6-3: Generic standards - Emission standard for residential, commercial and light-industrial environments |
| NFPA 55 : 2016 | COMPRESSED GASES AND CRYOGENIC FLUIDS CODE |
| NFPA 70 : 2017 | NATIONAL ELECTRICAL CODE |
| CFR 29(PT1910.1000 TO END) : 0 | LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR |
| IEC 61000-6-1:2016 | Electromagnetic compatibility (EMC) - Part 6-1: Generic standards - Immunity standard for residential, commercial and light-industrial environments |
| ISO 10012:2003 | Measurement management systems — Requirements for measurement processes and measuring equipment |
| IEC 61000-6-4:2006+AMD1:2010 CSV | Electromagnetic compatibility (EMC) - Part 6-4: Generic standards - Emission standard for industrial environments |
| NFPA 77 : 2014 | STATIC ELECTRICITY |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
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