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GB 18281.2-2015: Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization processes
GB 18281.2-2015
Sterilization of health care products - Biological indicators - Part 2. Biological indicators for ethylene oxide sterilization
ICS 11.080.01
C47
National Standards of People's Republic of China
Replacing GB 18281.2-2000
Sterilization of health care products - Biological indicators
Part 2. Biological indicators for ethylene oxide sterilization was
Part 2. Biologicalindicatorsforethyleneoxidesterilizationprocesses
(ISO 11138-2.2006, 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
1 5 test organisms
6 1 bacterial suspension
7 carrier and primary packaging 2
8 carrier contamination and biological indicators 2
9 Number of microbial resistance and 2
Appendix A (normative) Determination of ethylene oxide sterilization Resistance 3
Reference 4
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 2 GB 18281.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This Part replaces GB 18281.2-2000 "Sterilization of health care products - Biological indicators - Part 2. ethylene oxide sterilization Health
Was the indicator ", compared with GB 18281.2-2000, the main technical changes are as follows.
Chapter 5 --- improved test organisms;
--- Chapter 9 increased the number of microorganisms requirements;
--- Revised Appendix A.
This section uses the translation method identical with ISO 11138-2.2006 "Sterilization of health care products - Biological indicators - Part 2. Ring
Ethylene oxide 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);
--- GB/T 24628-2009 Sterilization of health care products - 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;
--- Delete foreword international standards;
--- Introduction of international standards and references appear to replace the corresponding country standards.
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, 3M China Ltd,
Ltd. Hangzhou gifted Nick disinfection equipment.
The main drafters of this section. Lu Wenjuan, Huang Xiulian, Huang Jingxiong.
This part of the standard replaces the previous editions are.
--- GB 18281.2-2000.
introduction
GB 18281.1 provides biological indicator production, labeling, test methods and performance requirements for these indicators is expected to contain sterilized
Ranjun carrier confirmation process and routine control and bacterial suspension. This section provides special procedure for ethylene oxide sterilization of biological indicator
Use requirements.
GB 18281 provides general requirements and test methods. This standard is to participate in professional manufacturers, users and regulators to develop.
The purpose of this standard is not to promote the development in the case is not recommended the use of biological indicators, but for biological indicator currently used to provide
specification.
Ethylene oxide sterilization Validation and routine control See GB 18279.
Select the biological indicator, use and test results to determine see GB/T 19972.
Sterilization of health care products - Biological indicators
Part 2. Biological indicators for ethylene oxide sterilization was
1 Scope
GB 18281 of the provisions of this part of the test organisms intended when evaluating the performance of the sterilizer and sterilization processes used, bacterial suspension, carrying contamination
Body, special requirements and test methods for biological indicator, which uses pure ethylene oxide sterilization or it is mixed with other dilution gas sterilization,
Sterilization temperature range is 29 ??? ~ 65 ???.
Note 1. ethylene oxide sterilization confirmation and routine control See GB 18279.
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
5.1 test organisms should shrink Bacillus spores, Bacillus subtilis strains or other requirements of this part of the accord.
Note 1. The original Bacillus subtilis some strains have been reclassified as Bacillus atrophy.
Note 2. It is confirmed that atrophy Bacillus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and is co-CIP77.18
Suitable strains.
5.2 If the test microorganism is not shrinking, Bacillus microbe resistance test should determine suitability.
6 bacterial suspension
ISO 11138-1 requirements apply to this section.
7 carrier and primary packaging
7.1 ethylene oxide sterilization Biological indicators carrier and primary packaging shall conform to ISO 11138-1.2006 required 5.2 and Appendix B of.
7.2 Confirm Biological indicators for ethylene oxide sterilization carrier and primary packaging meets the requirements of the test conditions shall be as follows.
a) Minimum exposure temperature. ???55 ???;
b) sterilizing agents. ???70% relative humidity conditions, the ethylene oxide concentration ???800mg/L;
c) maximum exposure temperature. specified by the manufacturer;
d) Exposure time. ???6h.
NOTE. As long as the selected condition is still within the range of effectiveness of the ethylene oxide sterilization process, those 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 The number and resistance of microorganisms
9.1 The manufacturer shall declare resistance biological indicator meets ISO 11138-1.2006 6.4 requirements.
9.2 biological indicator of viable cells per unit increment should be an integral multiple of ???0.1 ?? 10n represented, each unit can be bacteria per ml suspension per
A Ranjun carrier or biological indicator of each piece.
Viable count 9.3 contamination vectors and biological indicator should be ???1.0 ?? 106.
9.4 Application D resistance value and 54 ???/30 ???, or expressed, in minutes (min). Each batch of biological indicator D value should remain a
Decimals.
9.5 according to the test methods in Appendix A, including atrophy of Bacillus spores suspension, D values of carrier contamination and biological indicators at 54 ??? when
Should ???2.5min, and/or at 30 ??? should ???12.5min. Other microbes should not affect the D value of its use.
9.6 biological indicator resistance can also be expressed as FBIO (see ISO 11138-1.2006 3.7).
This section and other parts of the resistance properties of GB 18281 are valid under their specific conditions.
9.7 D value according to ISO 11138-1.2006 as specified in Appendix C and Appendix D is determined.
9.8 D value and survival - kill response characteristics of the resistance is determined to use the instrument, using a resistance meter to determine the appropriate process parameters (see Appendix A).
9.9 survival - kill zone can be ISO 11138-1.2006 Annex E calculated formula.
NOTE. This information is for the user when comparing different batches of the same manufacturer product of great value.
Example.
According to ISO 11138-1.2006 Appendix E of the formula, known minimum viable count and the minimum value of D in this section, survival - kill response characteristics are.
--- At 54 ??? when. survival time ???10min, kill time ???25min;
--- At 30 ???. survival time ???50min, kill time ???125min.
Appendix A
(Normative)
Determination of ethylene oxide sterilization resistance
A.1 Overview
This method requires special equipment. resistance meter. Ethylene oxide sterilization process specification resistance instrument parameters, see ISO 18472.
Test method, see A.2.
A.2 Test Method
A.2.1 The sample is placed on a suitable sample loading equipment.
A.2.2 The resistance meter reaction chamber preheated to the test temperature (54 ??? or 30 ???).
A.2.3 The carrier injector into the reaction chamber, close the chamber and start processing cycle.
A.2.4 according to the following steps to get started.
Step 1. The reaction chamber is evacuated to 10kPa ?? 0.5kPa.
Step 2. access sufficient water vapor, the relative humidity of the reaction chamber was 60% ?? 10%. And the conditions were maintained 30min ?? 1min.
Before steaming, samples should be allowed to warm to above the dew point to avoid possible formation of condensation water.
Step 3. Go through the interior of the ethylene oxide, reaching 600mg/L ?? 30mg/L in the 60s. When the exposure time of 0min, should no
Ethylene oxide fed.
Step 4. The conditions were maintained within the set time of ?? 5s.
Step 5. At the end of the exposure period, the reactor chamber is evacuated, down to 10kPa or less in the 60s, and then pass into the filtered air
Or an inert gas (such as nitrogen) to the ambient air pressure.
Step 6. The fifth step was repeated four times.
Step 7. Finally, the sample was removed and placed in culture medium. (See ISO 11138-1.2006 in Chapter 7)
A.2.5 transfer period should be recorded, all tests should be using the same time period.
A.3 resistance determination
Shall be in accordance with ISO 11138-1.2006 Determination of resistance method Appendix C, Appendix D and Appendix E of.
references
[1] GB 18279 (all parts) Sterilization of health care products of ethylene oxide
[2] GB/T 19972-2005 Sterilization of health care products - Biological indicators selection, use and test results to determine Guide
(ISO 14161.2000, IDT)