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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 ???
Introduction ???
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 ??2 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 ??2.
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 by the following procedure.
a) Minimum temperature exposure. should be higher than the manufacturer specified maximum exposure temperature 5 ??? or above.
b) Sterilization factor. dry saturated steam. Without using dry saturated steam wet heat sterilization process, for example using an air/steam mixture
Should be selected as suitable conditions and exceptions to be noted in this section.
c) maximum exposure temperature. should follow the manufacturer specified. As the manufacturer is not specified, it should be 140 ???.
d) Exposure time. ???30min.
NOTE. As long as the carrier is in the range of effectiveness of steam sterilization process, these conditions are selected to represent the actual inspection of the carrier.
8 carrier contamination and biological indicators
ISO 11138-1 requirements apply to this section.
9 Number of inoculation and resistance
9.1 Manufacturers should be based on ISO 11138-1.2006 4.3 provisions indicate biological indicator of the resistance parameters.
9.2 viable cell count should increment value per unit (eg per ml bacterial suspension for each carrier or each biological contamination indicator) microorganisms
???0.1 ?? 10n form of expression.
Total viable count 9.3 contamination vectors and biological indicator to be less than 1.0 ?? 105.
9.4 D resistance value shall be the value of 121 ??? when expressed in minutes (min). Each batch of contamination or biological indicator carriers should value D121
In minutes (min) as a unit, with an accuracy of 0.1min.
9.5 when tested in accordance with Appendix A, bacterial suspension for testing, contamination carrier or biological indicator used to Bacillus stearothermophilus
Bacilli (G.strarothermophilus) D121 value spores should ???1.5min. Determining D values for other species shall be based on the actual sterilization
need. Bacterial suspension, the carrier contamination and biological indicator test organisms z-values must be at least three kinds of temperature in the range of 110 ??? ~ 130 ???
Measured under degrees. The data used to calculate the value of z, z values must not be less than 6 ??? (z value shall be calculated in accordance with Appendix B).
Resistance 9.6 biological indicator can also be used FBIO value indicates (see ISO 11138-1.2006 3.7).
This section and other parts of GB 18281 resistance characteristics of the determination under standard test conditions.
9.7 Determination of D value see ISO 11138-1.2006 in Appendices C and D.
9.8 Biological indicators are available on the total number of test microorganisms D value (see Appendix A) by the survival curve method.
9.9 Calculation survival - kill curves refer ISO 11138-1.2006 Annex E formulas.
NOTE. Manufacturers of different batches of the same product to compare, can provide valuable information for the user.
Example. ISO 11138-1.2006 formula provided in Appendix E to the minimum number of viable cells and the minimum value of D can be calculated.
--- When the temperature is 121 ???. the survival time ???4.5min, kill time ???13.5min.
Appendix A
(Normative)
Determination of the resistance of moist heat sterilization
A.1 Overview
The method in this section requires specific equipment. resistance meter. Moist heat sterilization parameters specific resistance meter See ISO 18472.
Specific requirements for test methods see A.2.
A.2 Methods
A.2.1 The test sample is placed on the right of loading equipment.
A.2.2 Determination let preheated to the desired temperature, such as. 121 ??? ?? 0.5 ???.
A.2.3 The fixed sample loading equipment and a good sample into chamber, close the chamber and start the cycle operating procedures.
A.2.4 following the procedure of.
The first step. the reaction chamber is evacuated, within 2min reached 4.5kPa ?? 1kPa.
Step two. into the room through the steam, the temperature and pressure reaches a predetermined value in the 10s. 0min exposure time, should no steam
Through.
The third step. to maintain this condition within the specified exposure time.
Step four. At the end of the exposure phase, should be within 1min of the pressure in the chamber is reduced to 10kPa or less. The temperature must fall within 5s
Or less to 100 ???. Pass into the filtered air up to the outside atmospheric pressure.
Step five. After the end of the cycle, quickly remove the sample loading equipment and samples from the reaction chamber, and rapidly cooled. The sample was transferred to a growing culture of
Group and culture (see ISO 11138-1.2006 in Chapter 7).
A.2.5 sample transfer process should be recorded in writing, all tests should use the same time period.
Determination of resistance A.3
Shall be in accordance with ISO 11138-1.2006, Annex C, Method D and Appendix E Appendix predetermined measurement resistance.
Appendix B
(Normative)
??2 calculated z value and the correlation coefficient
B.1 according to ISO 11138-1.2006 method of obtaining data in Appendix C Appendix D or one provided by the value of the exposure to temperature plotted lgD
Z value can be obtained, in degrees Celsius (???). When using linear regression analysis, z value equal to "best fit" negative reciprocal of the slope.
Note. z value calculated correlation coefficient ??2 See 9.5.
B.2 calculate the best fit slope of the curve by the formula (B.1).
m =
nG-AB
nC-A2
(B.1)
Where.
m --- best-fit slope of the curve;
n --- D value/value of temperature;
G --- ?? (tlgy);
A --- ??t;
B --- ??lgy;
C --- ??t2.
Calculate the required data in Table B.1.
Table B.1 Example. Using linear regression analysis to calculate data
D value (y)
min
Exposure Temperature (t)
lgy t2 tlgy (lgy) 2
y1 t1 lgy1 t12 t1lgy1 (lgy1) 2
y2 t2 lgy2 t22 t2lgy2 (lgy2) 2
y3 t3 lgy3 t32 t3lgy3 (lgy3) 2
yn tn lgyn tn2 tnlgyn (lgyn) 2
A = ??
i = n
i = 1
ti B = ??
i = n
i = 1
lgyi C = ??
i = n
i = 1
ti
G = ??
i = n
i = 1
(Tilgyi) E = ??
i = n
i = 1
(Lgyi)
Bind variables ABCGE
B.3 Table B.2 gives a specific calculation example.
Table B.2 slope calculation example
D value (y)
min
Exposure Temperature (t)
lgy t2 tlgy (lgy) 2
y1 = 2.0 t1 = 121 lgy1 = 0.3010 t12 = 14641 t1lgy1 = 36.4210 (lgy1) 2 = 0.0906
y2 = 1.1 t2 = 124 lgy2 = 0.0414 t22 = 15376 t2lgy2 = 5.1336 (lgy2) 2 = 0.0017
y3 = 0.4 t3 = 129 lgy3 = -0.3979 t32 = 16641 t3lgy3 = -51.3291 (lgy3) 2 = 0.1583
A = ??
i = 3
i = 1
ti B = ??
i = 3
i = 1
lgyi C = ??
i = 3
i = 1
ti
G = ??
i = 3
i = 1
(Tilgyi) E = ??
i = 5
i = 1
(Lgyi)
Variable assignment A = 374 B = -0.0555 C = 46658 G = -9.7745 E = 0.2506