GB/T 18281.3-2024 PDF English
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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
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Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
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| GB 18281.3-2000 | English | 359 |
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Sterilization of health care products. Biological indicators. Part 3: Biological indicators for moist heat sterilization
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GB/T 18281.3-2024: Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT18281.3-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
GB/T 18281.3-2024 / ISO 11138-3.2017
Replacing GB 18281.3-2015
Sterilization of Health Care Products - Biological Indicators
- Part 3.Biological Indicators for Moist Heat Sterilization
Processes
(ISO 11138-3.2017, IDT)
Issued on: NOVEMBER 28, 2024
Implemented on: DECEMBER 1, 2025
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 7
2 Normative References... 7
3 Terms and Definitions... 7
4 General Requirements... 8
5 Test Microorganisms... 8
6 Bacterial Suspensions... 8
7 Carriers and Primary Packaging... 8
8 Contaminated Carriers and Biological Indicators... 9
9 Bacterial Count and Resistance... 9
Appendix A (normative) Method for Determination of Resistance in Moist Heat
Sterilization Processes... 11
Appendix B (normative) Calculation of z Value and Correlation Coefficient r2 Value13
Bibliography... 16
Foreword
This document was drafted in accordance with the rules provided in GB/T 1.1-2020 Directives
for Standardization - Part 1.Rules for the Structure and Drafting of Standardizing Documents.
This document is Part 3 of GB/T 18281 Sterilization of Health Care Products - Biological
Indicators. GB/T 18281 has issued the following parts.
---Part 1.General Requirements;
---Part 2.Biological Indicators for Ethylene Oxide Sterilization Processes;
---Part 3.Biological Indicators for Moist Heat Sterilization Processes;
---Part 4.Biological Indicators for Dry Heat Sterilization Processes;
---Part 5.Biological Indicators for Low-temperature Steam and Formaldehyde
Sterilization Processes;
---Part 7.Guidance for the Selection, Use and Interpretation of Results;
---Part 8.Method for Validation of a Reduced Incubation Time for a Biological Indicator.
This document serves as a replacement for GB 18281.3-2015 Sterilization of Health Care
Products - Biological Indicators - Part 3.Biological Indicators for Moist Heat Sterilization
Processes. In comparison with GB 18281.3-2015, apart from structural adjustments and
editorial modifications, the main technical changes are as follows.
---The temperature range for z value determination is modified (see 9.5; 9.5 of Version
2015);
---The expression of FBIO value is deleted (see 9.6 of Version 2015).
This document identically adopts ISO 11138-3.2017 Sterilization of Health Care Products -
Biological Indicators - Part 3.Biological Indicators for Moist Heat Sterilization.
Please be noted that certain content of this document may involve patents. The institution
issuing this document does not undertake the responsibility of identifying these patents.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee 200 on
Sterilization Techniques and Equipment of Standardization Administration of China (SAC/TC
200).
The drafting organizations of this document. Shandong SHINVA Medical Instrument Co., Ltd.;
Guangdong Medical Devices Quality Surveillance and Test Institute; Shandong BIOBASE
Sterilization of Health Care Products - Biological Indicators
- Part 3.Biological Indicators for Moist Heat Sterilization
Processes
1 Scope
This document specifies the requirements for test microorganisms, bacterial suspensions,
contaminated carriers, biological indicators and test methods intended for evaluating the
performance of moist heat as a sterilization factor in the sterilization processes.
NOTE 1.requirements for validation and routine control of moist heat sterilization are given in
ISO 17665.
NOTE 2.regulations in some countries or regions may have provided the safety requirements for
workplaces.
2 Normative References
The contents of the following documents constitute indispensable clauses of this document
through the normative references in the text. In terms of references with a specified date, only
versions with a specified date are applicable to this document. In terms of references without a
specified date, the latest version (including all the modifications) is applicable to this document.
GB/T 18281.1-2024 Sterilization of Health Care Products - Biological Indicators - Part 1.
General Requirements (ISO 11138-1.2017, IDT)
ISO 11138-1 Sterilization of Health Care Products - Biological Indicators - Part 1.General
Requirements
ISO 18472 Sterilization of Health Care Products - Biological and Chemical Indicators - Test
Equipment
NOTE. GB/T 24628-2009 Sterilization of Health Care Products - Biological and Chemical
Indicators - Test Equipment (ISO 18472.2006, IDT)
3 Terms and Definitions
The terms and definitions defined in ISO 11138-1 are applicable to this document.
The URLs of the terminology databases maintained by ISO and IEC for standardization are as
follows.
b) Sterilization factor. dry saturated steam. If the biological indicator is used in a moist
heat sterilization process without the use of dry saturated steam, for example, an air /
steam mixture is used, an appropriate air / steam mixture should be selected and
indicated to distinguish it from this document.
c) Maximum exposure temperature. specified by the manufacturer; if not specified by
the manufacturer, 140 C shall be used;
d) Exposure time. 30 min.
NOTE. while within the practical limitations of the moist heat sterilization processes, the exposure
conditions also need to represent realistic challenges for the carriers.
8 Contaminated Carriers and Biological Indicators
The requirements of ISO 11138-1 apply.
9 Bacterial Count and Resistance
9.1 The manufacturer shall declare that the resistance characteristics of the biological indicators
meet the requirements of 6.4 in GB/T 18281.1-2024.
9.2 The increment of each unit of viable bacteria on the biological indicators shall be specified
as integer multiples of 0.1 10n (for example, per milliliter of bacterial suspension, per
contaminated carrier or per biological indicator).
9.3 The viable bacterial count of the contaminated carriers and the biological indicators shall
be 1.0 105.
9.4 Resistance shall be expressed as the D value at 121 °C in minutes (min). The manufacturer
may select other temperatures. The D value of each batch of biological indicators or
contaminated carriers shall be specified as the D value [in minutes (min)] at 121 °C, with one
decimal place retained.
9.5 When tested in accordance with Appendix A, the D value at 121 C of the bacterial
suspensions containing Bacillus stearothermophilus spores, the contaminated carriers or other
biological indicators shall be 1.5 min. Other microorganisms shall have a D value that
supports their application. The z value of the test microorganisms in the bacterial suspensions,
and on the contaminated carriers and the biological indicators shall be determined at no less
than 3 temperature points within 110 °C ~ 138 °C. These data are used to calculate the z value,
which shall be 6 C (in accordance with Appendix B).
9.6 The resistance characteristics specified in this document and other parts of ISO 11138 shall
be defined using the specific key variables of the sterilization processes used.
9.7 The D value is determined in accordance with the methods in Appendix C and Appendix D
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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