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AAMI ISO TIR 11135-2 : 2008

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ANSI/AAMI/ISO 11135-1

Available format(s)

Hardcopy , PDF

Superseded date

10-09-2015

Superseded by

ANSI/AAMI/ISO 11135:2014

Language(s)

English

Published date

01-01-2008

€171.39
Excluding VAT

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO/TS 11135-2:2008
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management systems
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control
        of non-conforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Materials effects
   5.4 Environmental considerations
6 Process and equipment characterization
   6.1 Process characterization
   6.2 Equipment characterization
7 Product definition
   7.1 General
   7.2 Product safety and performance
   7.3 Microbiological quality
   7.4 Documentation
8 Process definition
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Varying load configurations
   9.5 Review and approval of validation
10 Routine monitoring and control
   10.1 General
   10.2 Parametric release
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 General
   12.2 Maintenance of equipment
   12.3 Requalification
   12.4 Assessment of change
Annex A (informative) Guidance on ISO 11135-1:2007 Annex
        A Determination of process lethality - Biological
        indicator/bioburden approach
Annex B (informative) Guidance on ISO 11135-1:2007 Annex
        B Conservative determination of lethal rate of
        the sterilization process - Overkill approach
Bibliography

Gives guidance for the requirements in ISO 11135-1:2007.

Committee
WG 01
DevelopmentNote
Supersedes AAMI TIR 20 and AAMI ISO 11135:1994. (01/2009)
DocumentType
Standard
Pages
59
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO/TS 11135-2:2008 Identical

AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'

ISO 15883-1:2006 Washer-disinfectors Part 1: General requirements, terms and definitions and tests
AS/NZS 4187:2014 Reprocessing of reusable medical devices in health service organisations
AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and 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
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
ISO 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO/TS 15883-5:2005 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy
ISO 15883-4:2008 Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 15883-2:2006 Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

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