GB 18281.3-2015 English PDF (GB18281.3-2015)

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GB 18281.3-2015: Sterilization of health care products -- Biological indicators -- Part 3: Biological indicators for moist heat sterilization processes
GB 18281.3-2015
Sterilization of health care products - Biological indicators - Part 3. Biological indicators for moist heat sterilization
ICS 11.080.01
C47
National Standards of People's Republic of China
Replacing GB 18281.3-2000
Sterilization of health care products - Biological indicators
Part 3. Biological indicators for moist heat sterilization
Part 3. Biologicalindicatorsformoistheatsterilizationprocesses
(ISO 11138-3.2006, IDT)
Issued on. 2015-12-10
2017-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 1 General
1 5 test organisms
2 6 bacterial suspension
7 carrier and primary packaging 2
8 carrier contamination and biological indicators 2
9 Number of inoculation and resistance 2
(Normative) Determination of moist heat sterilization resistance Appendix A 3
Appendix B (Normative Appendix) z value and the calculated correlation coefficient γ2 4
Reference 6
Foreword
All technical content in this Part of GB 18281 is mandatory.
GB 18281 "Sterilization of health care products - Biological indicators" is divided into five parts.
--- Part 1. General;
--- Part 2. Biological indicators for ethylene oxide sterilization thereof;
--- Part 3. Biological indicators for moist heat sterilization;
--- Part 4. Biological indicators for dry heat sterilization thereof;
--- Part 5. low temperature steam formaldehyde sterilization biological indicators.
This section is part of 3 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 18281.3-2000 "Sterilization of health care products - Biological indicators - Part 2. moist heat sterilization biological means
Was shown, "compared with GB 18281.3-2000, the main technical changes are as follows.
--- Test microorganism Bacillus stearothermophilus (Bacillusstrarothermophilus) renamed to Bacillus stearothermophilus
(Geobacillusstearothermophilus), an increase of Bacillus subtilis (B.subtillis) ATCC35021 (5230);
--- Change the maximum exposure temperature, 121 ℃ when the D value Accuracy;
--- The detailed calculation method and z values of the correlation coefficient γ2.
This section uses the translation method identical with ISO 11138-3.2006 "Sterilization of health care products - Biological indicators - Part 3. heat
Biological indicators for sterilization. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB 18281.1-2015 Sterilization of health care products - Biological indicators - Part 1. General (ISO 11138-1.2006,
IDT);
--- GB/T 24628-2009 Sterilization of health care products of biological and chemical indicators of test equipment (ISO 18472.2006,
IDT).
This part made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes;
--- Deleted international standards foreword.
Please note that some of the content of this document may involve patents. Issuer of this document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical sterilization techniques and equipment (SAC/TC200) centralized.
This section drafted by. Shandong Xinhua Medical Instrument Co., Ltd., Guangzhou, the State Food and Drug Administration Medical Devices Quality supervision
Governor Inspection Center.
The main drafters of this section. Wang Hongmin, Miao Xiaolin, Huang Xiulian.
This part of the standard replaces the previous editions are.
--- GB 18281.3-2000.
introduction
GB 18281.1 provides for the production, labeling, test methods and performance requirements for biological indicator, which is expected to contain indicators for sterilization
Validation of processes and routine control contamination carriers and suspensions. This section gives a moist heat sterilization process for a dedicated biological indicators of
Claim.
GB 18281 provides general requirements and test methods. On behalf of the advanced level of the national standards by the professional manufacturers, so
With regulatory authorities and developed jointly. The purpose of this section is not developed to promote the use of biological indicators, but the current use of biological
Indicator provided specifications.
Standard provides general requirements for validation and control of the sterilization process (see ISO 17665-1).
Selection, use and test results to determine biological indicators, see ISO 14161.
Sterilization of health care products - Biological indicators
Part 3. Biological indicators for moist heat sterilization
1 Scope
GB 18281 of the provisions of this part to be used as a heat medium heat sterilization sterilization process in the evaluation of the test organisms, suspensions
Requirements and test methods for liquid contamination carrier, the biological indicator.
This Part of the biological indicator applicable to the use of dry saturated steam heat sterilization process, does not apply to the use of steam-air mixture
Steam heat sterilization process.
Note 1. Refer to confirm moist heat sterilization and routine control ISO 17665-1.
Note 2. workplace safety reference to the relevant provisions of the State.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 11138-1.2006 Sterilization of health care products - Biological indicators - Part 1. General (Sterilizationofhealthcare
products-Biologicalindicators-Part 1. Generalrequirements)
ISO 18472 Sterilization of health care products biological and chemical indicators of test equipment (Sterilizationofhealthcare
products-Biologicalandchemicalindicators-Testequipment)
3 Terms and Definitions
Terms and definitions defined in ISO 11138-1 apply to this document.
4 General
ISO 11138-1 requirements apply to this section.
5 test organisms
Test bacteria test procedure set out in this section shall be used for the 5.1 to Bacillus stearothermophilus (Geobacillusstearothermophilus) of
Spores or other has been shown to meet the same performance requirements of this part of the species.
Note 1. Bacillus stearothermophilus (Bacillusstrarothermophilus) has been renamed to Bacillus stearothermophilus (G.stearothermophilus).
Note 2. Bacillus stearothermophilus ground (G.stearothermophilus) ATCC7953 (NCTC10007, DSM22 and CIP52.81) and ATCC
12980 (with NRRLB-4419) have been shown to meet the test requirements.
5.2 In addition to the use of Bacillus stearothermophilus ground (G.stearothermophilus) and Bacillus subtilis (Bacillussubtillis)
ATCC35021 strain (5230) except when tested, the resistance should be measured.
Note. In the case of less than 121 ℃, use Bacillus subtilis (B.subtillis) ATCC35021 (5230) and other species, especially for heat-sensitive liquid feed
Line sterilization process.
6 bacterial suspension
ISO 11138-1 requirements apply to this section.
7 carrier and primary packaging
7.1 and carrier requirements for primary packaging shall conform to ISO 11138-1.2006 required 5.2 and Appendix B of.
7.2 exposure conditions should be determined b...