ISO 11138-1:2017
Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$343.00 NZD
|
|
| HardCopy |
$389.00 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems
4.1.2 Traceability
4.1.3 Finished product requirements
4.1.4 Personnel
4.2 Test organism
4.2.1 Strain
4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling)
4.4 Storage and transport
5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier
5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of population and resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms
6.4 Resistance characteristics
6.5 Test conditions
7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
7.4 Software validation
7.5 Incubation time using detection system
Annex A (normative) Determination of viable count
Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
Annex C (normative) D value determination by survivor curve method
Annex D (normative) D value determination by fraction negative method
Annex E (normative) Survival-kill response characteristics
Annex F (informative) Relationship between components of biological indicators
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS ISO 11137.1:2006
Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
-
AS/NZS ISO 11137.3:2006
Sterilization of health care products - Radiation - Guidance on dosimetric aspects
-
BS EN 556-1:2024
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
-
BS EN 556-1:2024 - TC
Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality management systems
4.1.2 Traceability
4.1.3 Finished product requirements
4.1.4 Personnel
4.2 Test organism
4.2.1 Strain
4.2.2 Originating inoculum for suspension
4.2.3 Test organism count
4.3 Information to be provided by the manufacturer (labelling)
4.4 Storage and transport
5 Specific manufacturing requirements
5.1 Suspensions
5.2 Carrier, primary and secondary packaging
5.3 Inoculated carrier
5.4 Biological indicators
5.5 Self-contained biological indicators
6 Determination of population and resistance
6.1 General resistance requirements
6.2 Test organism
6.3 Population of test organisms
6.4 Resistance characteristics
6.5 Test conditions
7 Culture conditions
7.1 Incubator
7.2 Growth medium
7.3 Incubation
7.4 Software validation
7.5 Incubation time using detection system
Annex A (normative) Determination of viable count
Annex B (normative) Determination of growth inhibition by carriers and primary packaging materials exposed to sterilization processes
Annex C (normative) D value determination by survivor curve method
Annex D (normative) D value determination by fraction negative method
Annex E (normative) Survival-kill response characteristics
Annex F (informative) Relationship between components of biological indicators
Bibliography