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AAMI TIR20 : 2001

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION
Available format(s)

Hardcopy , PDF

Superseded date

20-11-2008

Language(s)

English

Published date

01-01-2001

Glossary of equivalent standards
Committee representation
Introduction
1 Scope
2 Cited references
3 Definitions
4 Equipment requirements
  4.1 Preconditioning
  4.2 Sterilization chamber
  4.3 Aeration/degassing
5 Process analysis
  5.1 Overview
  5.2 Frequency of EO analysis
  5.3 EO analysis sampling location(s)
  5.4 EO analysis accuracy
6 Process development
  6.1 Overview
  6.2 Use of biological indicators to develop the
      sterilization process
  6.3 Methods of determining lethality
      6.3.1 Methods overview
      6.3.2 Steps required by both methods
      6.3.3 Method A: Survivor curve construction-Enumeration
            of the BIs
      6.3.4 Method B: Fraction negative
      6.3.5 Sterilization cycle development process
            troubleshooting
  6.4 Sampling considerations for process development studies
  6.5 Performance of Method A or B in a pilot or a production
      chamber
      6.5.1 Four ways that Method A or B may be performed
      6.5.2 Establishing relationship between pilot
            chamber and production chamber
  6.6 Calculation of the sterilization cycle
  6.7 Documentation of the process development
7 Validation
  7.1 Commissioning (IQ/OQ)
  7.2 Performance qualification (PQ)-Microbiological
  7.3 Load configuration
  7.4 Performance qualification-Physical
  7.5 Revalidation
8 Routine processing
9 Product release
  9.1 General
  9.3 Electronic records and signatures
Annexes
A - Gas analysis issues
B - Sensor monitoring tables
C - Factors influencing accuracy and decisions
    regarding the direct analysis of EO concentration

Describes the rationale and approach necessary for the implementation of parametric release for product sterilized by ethylene oxide (EO).

Committee
TG 01
DocumentType
Standard
Pages
32
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

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)
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)
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
CSA ISO 11712:14 (R2019) Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors (Adopted ISO 11712:2009, first edition, 2009-05-15)
ISO 11712:2009 Anaesthetic and respiratory equipment — Supralaryngeal airways and connectors
BS ISO 11712:2009 Anaesthetic and respiratory equipment. Supralaryngeal airways and connectors
CSA ISO 11712 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - SUPRALARYNGEAL AIRWAYS AND CONNECTORS
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2

AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
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
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements

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