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ANSI/AAMI/ISO 11138-4:2017

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES

Available format(s)

Hardcopy , PDF

Superseded date

04-20-2024

Language(s)

English

Published date

08-01-2017

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
 ISO 11138-4:2017
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological
  indicators
9 Population and resistance
Annex A (normative) - Method for
        determination of resistance
        to dry heat sterilization
Annex B (normative) - Calculation of
        z value
Bibliography

Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 degrees C to 180 degrees C.

DocumentType
Standard
ISBN
978-1-57020-681-8
Pages
21
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11138-4:2017 Identical

ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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

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US$129.00
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