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GB 18281.5-2015: Sterilization of health care products -- Biological indicator -- Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
GB 18281.5-2015
Sterilization of health care products - Biological indicator - Part 5. Biological indicators for low-temperature steam and formaldehyde sterilization processes
ICS 11.080.01
C47
National Standards of People's Republic of China
Sterilization of health care products - Biological indicators
Part 5. Low temperature steam formaldehyde sterilization biological indicators
Sterilizationofhealthcareproducts-Biologicalindicator-Part 5. Biological
(ISO 11138-5.2006, 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
Introduction ???
Introduction ???
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 1 General requirements
1 5 test bacteria
6 1 bacterial suspension
7 carrier and the inner packaging 2
8 carrier contamination and biological indicators 2
9 Number of microbial resistance and 2
Methods Appendix A (normative) Determination of low temperature steam formaldehyde sterilization process Resistance 3
Annex B (informative) low temperature steam formaldehyde principle with liquid biological indicators Test Method 4
Reference 5
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 the 5 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method identical with ISO 11138-5.2006 "Sterilization of health care products Biological indicators - Part 5. Low
Temperature steam formaldehyde sterilization biological indicators. "
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).
This part made the following editorial changes.
--- According to GB/T 1.1 requirements of a number of editorial changes;
--- Delete 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 Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized.
This section drafted by. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, located in Hangzhou Tailin Biotechnology
Preparation Co., Ltd. Shandong Xinhua Medical Instrument Co., Ltd.
The main drafters of this section. Xu Honglei, summer letter group, the new Mr Wong, Zhu Xiaoming.
introduction
GB 18281 specifies the biological indicator for monitoring sterilization cycle in the production, labeling, test methods and general performance requirements
Further comprising a carrier intended to be used to verify and monitor the bacterial suspension sterilization process. GB 18281 This section gives specific for low temperature steam
Biological indicator of claim formaldehyde vapor sterilization process.
GB 18281 standard series provided the general requirements and test methods required. Currently this series is advanced by professional standards
Manufacturers, users and regulatory authorities involved in standards development. The intention is not only not promote the use is not recommended in biological terms
Indicators, but to provide general requirements now known that the production of biological indicators.
Standard provides the general requirements for the verification and monitoring of low temperature steam formaldehyde sterilization processes (see ISO 14937).
Note. The standard has been published in some countries or regions may cover the requirements for sterilization or biological indicators.
The results of biological indicator selection, use and interpretation of visible ISO 14161.
Sterilization of health care products - Biological indicators
Part 5. Low temperature steam formaldehyde sterilization biological indicators
1 Scope
GB 18281 of the provisions of this part of the test microorganisms, bacterial suspension, the carrier contamination, biological indicator and low temperature steam formaldehyde sterilization
General requirements for sterilization agent to assess the treatment effect of biological indicator test method.
Note 1. The requirements for low temperature steam formaldehyde sterilization process control and confirmation, see ISO 14937.
Note 2. For the safety requirements in the workplace, see national or regional regulations.
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. Genralrequirements)
3 Terms and Definitions
As defined in ISO 11138-1 and the following terms and definitions apply to this document.
3.1
Low temperature steam formaldehyde sterilization low-temperaturesteamandformaldehydesterilization
By the power exhaust, so that pre-packaged goods in the vacuum state is exposed to steam at temperatures below 100 ???, the injection of formaldehyde gas,
Such sterilizing agents in the maintenance time remains steady process.
4 General requirements
ISO 11138-1 requirements apply to this section.
5 test bacteria
5.1 Test bacteria should be Bacillus stearothermophilus or other has been found to comply with the requirements of this strain of microorganism equivalent performance.
Note 1. Bacillus stearothermophilus have been reclassified to Bacillus stearothermophilus.
Note 2. The currently considered applicable to Bacillus stearothermophilus, as NCIB8224, DSM6790, ATCC10149 and ATCC12980.
5.2 If the use of a test bacteria Bacillus stearothermophilus ground outside, then this strain of bacteria resistance test suitability should be determined.
6 bacterial suspension
ISO 11138-1 requirements apply to this section.
7 carrier and the inner packaging
7.1 low temperature steam formaldehyde sterilization agent biological indicator carriers and inner packing material should conform to ISO 11138-1.2006 5.2
And ISO 11138-1.2006 requirements in Appendix B of.
Note. Due to the cellulose surface chemical formaldehyde adsorption filter paper type is not suitable as a carrier.
7.2 should comply with the determined exposure conditions.
a) Minimum temperature exposure. not less than 5 ??? (above the manufacturer claims the highest temperature);
b) maximum exposure temperature. According to the manufacturer's maximum claims; If the manufacturer is not declared, should not be less than the maximum exposure temperature
100 ???;
c) Exposure time. not less than 60min.
Note. These conditions have become a caution, with practical limits on bacteria in the range of application of low temperature steam formaldehyde sterilization process. Selection criteria to be able to significantly
It shows the actual low temperature steam formaldehyde sterilization process to the actual requirements of the carrier.
8 carrier contamination and biological indicators
ISO 11138-1 requirements apply to this section.
9 The number and resistance of microorganisms
9.1 Manufacturers should be based on ISO 11138-1.2006 6.4 Characteristics of predetermined resistance requirements.
9.2 Proliferation amount viable count should be less than 0.1 ?? 10n/per unit (eg. bacteria per ml suspension, each to be inoculated with bacteria, each student
Adhesive tape cells).
With cell proliferation and the amount of biological cells with 9.3 to be vaccinated should be not less than 1.0 ?? 105.
9.4 resistance should be expressed as D value at 60 ???, and in minutes (min). Each batch/lot of contamination or biological indicator carriers D
D values apply at 60 ??? that is kept to one decimal place.
9.5 when tested in accordance with Appendix A, the medium carrier contamination or biological indicator comprises D60 value to stearothermophilus Bacillus
Should ???6min. Other micro-organisms should also be applied to the D value.
Resistance 9.6 biological indicator can also be used FBIO value indicates (see ISO 11138-1.2006 3.7). This section GB 18281 and its
The specific part of his resistance shall be tested in accordance with specific conditions standards.
9.7 shall be according to ISO 11138-1.2006 Determination of D value of Appendices C and D of the given method.
9.8 D value determination and survival - kill response characteristics based on the process parameters in Appendix A.
9.9 Survival - killing range available ISO 11138-1.2006 Appendix E formula to calculate.
NOTE. To compare different batches of the same manufacturer's product information for the user is useful.
Example. Apply ISO 11138-1.2006 Appendix E of the formula and the population and minimum D values given in this section, survival - kill reaction characteristic values are.
--- 60 ??? when. survival time ???18min, kill time ???54min.
Appendix A
(Normative)
Determination of low temperature steam formaldehyde sterilization process resistance method
A.1 General
This method is based on a carrier immersed in formalin contamination qualitative testing. The results of this test method than the use of gas cavity
The results of the method have better reproducibility.
A.3 provides the special requirements of the test method.
A.2 Ranjun carrier exposure conditions
A.2.1 test system comprising an aqueous solution of formaldehyde containing 10mL test tube, and the tube placed in a water bath of automatic temperature control. Measurement
Test systems should be able to (accurate to ?? 10s) period of time to maintain a specific exposure conditions in 1min ~ 150min.
Chemical analysis methods to determine the concentration of the aqueous formaldehyde solution A.2.2.
A.2.3 the method should be validated.
A.3 Method
A.3.1 The carrier contamination completely immersed in the test tube has been preheated to 60 ??? ?? 0.5 ??? of 1mol/L ?? 0.01mol/L of aqueous formaldehyde
Solution.
A.3.2 confirm Ranjun carrier is completely immersed in formalin instead of floating on the surface.
A.3.3 The protection technology to prevent accidental contamination during testing.
A.3.4 at the end of the set exposure time, remove the formaldehyde solution in the carrier contamination.
A.3.5 remove excess liquid carrier, which will be equipped with immersion filtered 2% Na2SO3 solution tubes 10min at room temperature,
The reaction on the carrier out of the residual formaldehyde. Cover tube. Try not to pay attention to stir formaldehyde solution and neutralizer in order to prevent "washed away" micro test
biological.
NOTE. histidine and cysteine are effective neutralizers.
A.3.6 specific growth media should guarantee coverage test microorganisms.
NOTE. This test applies soybean casein digestive enzymes.
A.3.7 The carrier was transferred to a growth medium containing 10mL (A.3.6) tube. Cover tube.
A.3.8 The tubes were kept 90 ??? 60min to stimulate spore activity.
A.3.9 Finally, the culture carrier (see ISO 11138-1.2006 in Chapter 7).
A.4 Determination of resistance
Resistance characteristic values are applied ISO 11138-1.2006 Annex C, D and Appendix E for a given method for determining the Appendix.
Appendix B
(Informative)
Low temperature steam formaldehyde Biological indicators for liquid test method principle
B.1 General
To indicate Test method reproducibility, use of specific test equipment (resistance tester) and test methods. In the low-temperature steam
Formaldehyde sterilization process, the resistance tester formaldehyde gas concentration is extremely difficult to achieve a stable, because when a certain amount of formaldehyde injected into the container, will
A small amount of water droplets (condensate) dissolved formaldehyde appears. It was dissolved in water in accordance with the concentration of different temperatures, higher than in the gaseous
State concentration of 1000-fold to 10,000-fold.
Therefore, this part of the formaldehyde concentration can clear liquid test methods in order to achieve reproducible test methods.
B.2 low temperature steam formaldehyde sterilization processes
Even under continuous steam conditions and a stable concentration of formaldehyde gas sterilization process is still heavily dependent on the design of the sterilization chamber and the negative
Load characteristics thereof. Formaldehyde sterilization process can be simply divided into two steps.
a) in the steam sterilization process, the load surface will produce droplets condensate film, the condensation process is very fast;
b) because the formaldehyde concentration changes in the gas-liquid equilibrium state of great (1.1000 ~ 1.10 000), the time to reach the required balance
Relatively long, in practice, the time required for 10min ~ 2h.
The sterilization process depends on the concentration of formaldehyde in the liquid state, for example, the surface of the condensate. Confirm this equilibrium conditions constant term non-time
Often difficult.
references
[1] ISO 14161.2000 Sterilizationofhenlthcareproducts-Biologicalindicators-Guidancefor
theselection, useandinterpretationofresults
[2] ISO 14937.2000 Sterilizationofhenlthcareproducts-Generalrequirementsforcharacter-
izationofasterilizingagentandthedevelopmentvalidatinecontrolofsterilizationprocessfor
medicaldevices
[3] EN14180.2003 Sterilizersformedicalpurposes-Lowtemperaturesteamandformalde-
hydesterilizers-Requirementsandtesting