GB/T 18281.4-2024 PDF English
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Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
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| GB 18281.4-2015 | English | 170 |
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GB/T 18281.4-2024: Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry 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/GBT18281.4-2024
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
CCS C 47
GB/T 18281.4-2024 / ISO 11138-4.2017
Replacing GB 18281.4-2015
Sterilization of Health Care Products - Biological Indicators
- Part 4.Biological Indicators for Dry Heat Sterilization
Processes
(ISO 11138-4.2017, 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 of Biological
Indicators for Dry Heat Sterilization Processes... 11
Appendix B (normative) Calculation of z Value... 12
Bibliography... 15
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 4 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 18281.4-2015 Sterilization of Health Care
Products - Biological Indicators - Part 4.Biological Indicators for Dry Heat Sterilization
Processes. In comparison with GB 18281.4-2015, apart from structural adjustments and
editorial modifications, the main technical changes are as follows.
---The requirements for D160 value are modified (see 9.5; 9.5 of Version 2015);
---The requirements for resistance characteristics are modified (see 9.6; 9.6 of Version
2015).
This document identically adopts ISO 11138-4.2017 Sterilization of Health Care Products -
Biological Indicators - Part 4.Biological Indicators for Dry Heat Sterilization Processes.
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 BIOBASE Disinfection Equipment Co.,
Ltd.; Guangdong Medical Devices Quality Surveillance and Test Institute; Shandong SHINVA
Medical Instrument Co., Ltd.
Sterilization of Health Care Products - Biological Indicators
- Part 4.Biological Indicators for Dry Heat Sterilization
Processes
1 Scope
This document specifies the requirements and test methods for test microorganisms, bacterial
suspensions, contaminated carriers and biological indicators to be used in evaluating the
performance of sterilizers and sterilization processes. The sterilizers and sterilization processes
use dry hot air with a sterilization temperature range of 120 C ~ 180 C.
NOTE 1.for validation and routine control of dry heat sterilization processes, see ISO 20857.
NOTE 2.for workplace safety, refer to relevant national or regional regulations.
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.
4 General Requirements
The requirements of ISO 11138-1 apply.
5 Test Microorganisms
5.1 The test microorganisms shall be spores of Bacillus atrophaeus or other microbial strains
that have been proven to have equivalent performance meeting the requirements of this
document.
NOTE 1.some strains of Bacillus subtilis have been re-classified as Bacillus atrophaeus.
NOTE 2.Bacillus atrophaeus CIP 77.18, NCIMB 8058, DSM 675, NRRL B-4418 and ATCC 9372
or Bacillus subtilis DSM 13019 have been found to be suitable strains1).
5.2 If test microorganisms other than Bacillus atrophaeus is used, the applicability of the
resistance of the test microorganisms shall be determined.
6 Bacterial Suspensions
The requirements of ISO 11138-1 apply.
7 Carriers and Primary Packaging
7.1 The applicability of materials for the carriers and primary packaging of biological indicators
for dry heat sterilization shall be proven to comply with the requirements of 5.2 and Appendix
B in GB/T 18281.1-2024.
7.2 The exposure conditions for determining compliance shall be as follows.
a) Minimum exposure temperature. 5 C or above the nominal maximum temperature
specified by the manufacturer;
b) Sterilization factor. dry hot air;
c) Maximum exposure temperature. specified by the manufacturer; if not specified by
the manufacturer, the maximum exposure temperature should be 180 C;
d) Exposure time. 30 min.
1) Bacillus atrophaeus CIP 77.18, NCIMB 8058, DSM 675, NRRL B-4418 and ATCC 9372 or Bacillus subtilis DSM
13019 are examples of suitable commercially available products. This information is given for the convenience of
the users of this document and does not constitute an endorsement of these products.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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