GB 18281.4-2015 English PDF (GB18281.4-2015)

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GB 18281.4-2015: Sterilization of health care products -- Biological indicators -- Part 4: Biological indicators for dry heat sterilization processes
GB 18281.4-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18281.4-2015 / ISO 11138-4:2006
Sterilization of health care products - Biological indicators -
Part 4: Biological indicators for dry heat sterilization
processes
(ISO 11138-4:2006, IDT)
ISSUED ON: DECEMBER 10, 2015
IMPLEMENTED ON: JANUARY 1, 2017
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 General requirements ... 6
5 Test organisms ... 7
6 Suspension ... 7
7 Carriers and primary packaging ... 7
8 Inoculated carriers and biological indicators ... 7
9 Microbial population and resistance ... 8
Appendix A (Normative) Method for determination of dry heat sterilization resistance
... 10
Appendix B (Normative) Calculation of z value ... 11
References ... 14
Foreword
All technical contents of this part of GB 18281 are mandatory.
GB 18281 “Sterilization of health care products - Biological indicators” is divided into
the following five 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.
This part is part 4 of GB 18281.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is translated from and identical to ISO 11138-4:2006 “Sterilization of health
care products - Biological indicators - Part 4: Biological indicators for dry heat
sterilization processes”.
The Chinese documents that have consistent correspondence with the international
documents normatively cited in this part are as follows:
--- GB 18281.1-2015 Sterilization of health care products - Biological indicators -
Part 1: General requirements (ISO 11138-1:2006, IDT);
--- GB/T 24628-2009 Sterilization of health care products - Biological and chemical
indicators - Test equipment (ISO 18472:2006, IDT).
The following editorial changes are made in this part:
--- Some editorial modifications are made in accordance with the requirements of
GB/T 1.1;
--- The foreword of the international standard is deleted;
--- Some international standards cited in the Introduction and References are
replaced with corresponding Chinese standards.
Sterilization of health care products - Biological indicators -
Part 4: Biological indicators for dry heat sterilization
processes
1 Scope
This part of GB 18281 specifies the special requirements and test methods for test
organisms, suspensions, inoculated carriers, and biological indicators to be used in the
evaluation of sterilizer performance and sterilization process. The sterilizer shall use
dry heat air for sterilization, and the sterilization temperature range shall be
120 ℃~180 ℃.
Note 1: Refer to GB/T 19974 for the confirmation and routine control of dry heat sterilization.
Note 2: Refer to the relevant regulations of the country for the safety of the workplace.
2 Normative references
The following documents are essential to the application of this document. For the dated
documents, only the versions with the dates indicated are applicable to this document;
for the undated documents, only the latest version (including all the amendments) is
applicable to this standard.
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part
1: General requirements
ISO 18472 Sterilization of health care products - Biological and chemical indicators
- Test equipment
3 Terms and definitions
The terms and definitions defined in ISO 11138-1 apply to this document.
4 General requirements
The requirements of ISO 11138-1 apply to this part.
9 Microbial population and resistance
9.1 The manufacturer shall state that the resistance of the biological indicator complies
with the requirements in 6.4 of ISO 11138-1:2006.
9.2 The increment of viable count per unit on the biological indicator shall be expressed
as an integer multiple of ≤0.1×10n (for example: per milliliter of suspension, per
inoculated carrier, or per biological indicator).
9.3 The amount of viable count in the inoculated carrier and biological indicator shall
be ≥1.0×106.
9.4 The resistance shall be represented by the D value at 160°C, and the unit is minutes
(min). The D value of each batch of biological indicators or inoculated carriers shall be
represented by the D value at 160°C, with one decimal place reserved.
9.5 When being tested according to the conditions in Appendix A, the D160 values (D
value at 160°C) of the suspensions, the inoculated carriers, or the biological indicators
containing Bacillus atrophaeus spores shall be ≥2.5 min. Other microorganisms shall
have D values that do not affect their use. The z value of the test organisms in the
suspension, on the inoculated carrier, or in the biological indicator shall be determined
by taking not less than three temperature points within the range of 150°C~180°C.
These data will be used to calculate the z value, and the z value shall be ≥20 ℃ (see
Appendix B).
9.6 The resistance of biological indicators can also be expressed by FBIO value (see 3.7
in ISO 11138-1:2006).
The resistance characteristics specified in this part and other parts of GB 18281 shall
be determined by the specific test conditions specified in the standard.
9.7 The D value shall be determined according to the methods in Appendix C and
Appendix D of ISO 11138-1:2006.
9.8 Determination of the D value and survival-kill response characteristics requires the
use of a resistometer that can apply its process parameters (see Appendix A).
Note: The values mentioned above are suitable for the dry heat sterilizer with forced air supply,
temperature maintained at 160°C, and operation period of 2 h.
9.9 The survival-kill interval can be calculated by the formula in Appendix E of ISO
11138-1:2006.
Note: This information is valuable for users to compare different batches of products from the same