GB/T 19972-2018Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces GB/T 19972-2005 "Guidelines for the Selection, Use and Result Judgment of Sterilized Biological Indicators for Healthcare Products".

The main technical differences between this standard and GB/T 19972-2005 are as follows.

--- Added "duration", "installation identification", "running identification", "performance identification", "process variable", "reference microorganism", "spore log reduction" Terms and definitions of "less value" "sterility assurance level" and "survival-kill interval" (see 3.6, 3.8, 3.11, 3.12, 3.16, 3.17, 3.19, 3.21 and 3.26);

--- Added the informative appendix "calculation of z values" (see Appendix E);

--- Added the informative appendix "survival curve method to measure D value" (see Appendix F);

--- Added the informative appendix "Survival-killing response characteristics (see Appendix G)".

This standard uses the translation method equivalent to the ISO 14161:2009 "healthcare product sterilization biological indicator selection, use and knot Judgment Guide.

The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows.

---GB 18278.1-2015 Health care products Sterilization and moist heat Part 1: Development, validation and validation of medical device sterilization processes General control requirements (ISO 17665-1:2006, IDT)

---GB 18279.1-2015 Health care products Sterilization of ethylene oxide Part 1: Development of medical device sterilization process, indeed Recognition and routine control requirements (ISO 11135-1:2007, IDT)

--- GB 18281.1-2015 Sterilization of biological indicators for health care products - Part 1: General (ISO 11138-1:2006, IDT)

--- GB 18281.2-2015 Sterilization of biological indicators for health care products - Part 2: Biological indications for the sterilization of ethylene oxide (ISO 11138-2:2006, IDT)

--- GB 18281.3-2015 Sterilization of biological indicators for health care products - Part 3: Biological indicators for moist heat sterilization (ISO 11138-3:2006, IDT)

--- GB 18281.4-2015 Sterilization of biological indicators for health care products - Part 4: Biological indicators for dry heat sterilization (ISO 11138-4:2006, IDT)

--- GB 18281.5-2015 Sterilization of biological indicators for health care products - Part 5: Indicator (ISO 11138-5:2006, IDT)

--- GB/T 19973.1-2015 Microwaveological methods for the sterilization of medical devices - Part 1 Ding (ISO 11737-1:2006, IDT)

---GB/T 19974-2005 Characteristics of Sterilization Factor of Healthcare Products and Setting and Confirmation of Sterilization Process of Medical Devices General requirements for general control and control (ISO 14937:2000, IDT)

Introduction

This standard provides guidance on the selection, use, and determination of biological indicators when applied to the development, validation, and monitoring of sterilization processes.

The procedures described in this standard are of a general nature and are not themselves a comprehensive development, validation and monitoring process for the sterilization of healthcare products. The purpose of this standard is not to force the use of biological indicators in a process, but to correctly select them if biological indicators are used. Choose and use guidelines to avoid misleading results.

In this standard, users can obtain biological indicator selection guides for specific sterilization processes and key parameters, and use the health correctly. A guide to objects.

The user should select a biological indicator that is appropriate for the particular sterilization process they employ. Biological indications due to large differences in sterilization processes, it is difficult for the manufacturer to anticipate all possible uses of the product, so the manufacturer can only identify its biological indicator for a particular use. For mining The specific sterilization process used should be properly selected, used, recycled, and judged by the user.

Conditions for storage and transport of biological indicators prior to use, use of biological indicators or sterilizer process parameters may be indicative of biological indicators Adverse effects, in addition to the culture techniques used after exposure to the process, including culture temperature, media type, manufacturer and specific batches may also It is the measured resistance associated with recovery and growth. Therefore, it should be stored and used in accordance with the recommendations of the biomarker manufacturer. After sterilization, biological indicators should be aseptically transferred (if applicable) and cultured as specified by the biomarker manufacturer.

It should be noted that the biological indicator is not intended to indicate that the sterilized item is indeed sterile. But to test a known sterilization process and the effectiveness of the sterilization equipment used, which is based on the principle of assessing microbial lethality at a sterility assurance level. This Class studies should be conducted by trained and appropriate personnel.

1 Scope

This standard provides for the selection, use, and judgment of biological indicators when applied to the development, validation, and routine monitoring of sterilization processes.

This standard applies to biological indicators of existing national standards.

Note 1: See ISO 11138 for an example.

Note 2: The general information provided in this standard also applies to processes and biological indicators not mentioned in the current national standards. Such as new and developing sterilization process.

This standard does not consider processes that physically remove microorganisms only, such as filtration.

This standard does not apply to the use of various combination processes, such as washing and sterilizing or pipe flushing and steaming. This standard does not apply to liquid sterilization processes.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 24628-2009 Sterilization biological and chemical indicator test equipment for healthcare products (ISO 18472:2006, IDT)

ISO 11135-1 Sterilization of ethylene oxide for health care products - Part 1. Development, validation and routine Control requirements (Sterilizationofhealthcareproducts-Ethyleneoxide-Part 1. Requirements fordevelop- Ment,validationandroutinecontrolofasterilizationprocessformedicaldevices)

ISO 11138-1:2006 Medicinal products - Sterilization of biological indicators - Part 1 products-Biologicalindicators-Part 1: Generalrequirements)

ISO 11138-2 Sterilization of biological indicators for health care products - Part 2. Biological indicators for the sterilization of ethylene oxide (Sterili-zationofhealthcareproducts-Biologicalindicators-Part 2: Biologicalindicatorsforethyleneoxide Sterilizationprocesses)

ISO 11138-3 Sterilization of biological indicators for health care products - Part 3 ofhealthcareproducts-Biologicalindicators-Part 3: Biologicalindicatorsformoistheatsterilization Processes)

ISO 11138-4 Biomedical products - Sterilization of biological indicators - Part 4. Sterilization for dry heat sterilization ofhealthcareproducts-Biologicalindicators-Part 4: Biologicalindicatorsfordryheatsterilization Processes)

ISO 11138-5 Biomedical products - Sterilization of biological indicators - Part 5. Biological indicators for steril (Sterilizationofhealthcareproducts-Biologicalindicators-Part 5. Biologicalindicatorsforlow-tem- Peraturesteamandformaldehydesterilizationprocesses)

ISO 11737-1 Methods of sterilizing microbiology of medical devices - Part 1 (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 1: Determinationofapopulationof Microorganisms products)

ISO 14937 Characteristics of Sterilization Factors for Healthcare Products and Development, Validation and Routine Control of Medical Device Sterilization Processes General requirements (Sterilizationofhealthcareproducts-Generalrequirementsfor characterizationofasterili- Zingagentandthedevelopment,validationandroutinecontrolofasterilizationprocessformedicalde- Vices)

ISO 17665-1 Sterilization of moisturizing products for health care products - Part 1. Development, validation and routine control Requirements (Sterilization of health care products - Moistheat-Part 1. Requirements for the development, Validationandroutinecontrolofasterilizationprocessformedicaldevices)

3 Terms and definitions

The following terms and definitions apply to this document.

4 General

4.1 This standard provides guidance on biological indicators, which are generally applicable to any sterilization process, including those not specified in the relevant standards. New sterilization process.

4.2 The use of biological indicators is usually in the program documentation and/or instructions.

Note: The use of quality management systems such as ISO 13485 [7] generally meets the requirements of this clause.

4.3 Biological indicators should generally be combined with physical and/or chemical measurements to demonstrate the effectiveness of the sterilization process. When in the process of sterilization Physical and/or chemical variables are outside the specified limits, and the cause of the sterilizer's inability to obtain its process parameters should be evaluated and the problem Corrected. Systems and/or procedures should be established to evaluate any deviation from the periodic process limits and the completeness of the reasons for accepting any deviations Piece.

4.4 A qualified biological indicator includes carrier material, packaging, and certain microbial components that can be disposed of without the need for special container equipment. Health Long conditions should be properly documented and should be described simply and appropriately to avoid user misunderstandings as much as possible.

4.5 Internationally, there is no formal approval system for the sale and use of biological indicators under certain conditions or conditions. but In some countries, regulatory agencies have special procedures for the selection and use of biological indicators and for the identification and management of sterile or sterilized products. Requirements.

4.6 Biological indicators represent a microbial challenge in a sterilization process and are used to verify whether a sterilization process can inactivate those that are The bacterial process has microorganisms that determine resistance. The test microorganisms used in biological indicators have resistance to sterilization, often exceeding the usual The resistance of bio-loaded microorganisms, however, there are also some microorganisms that may exhibit resistance beyond the test microorganisms. a suitable creature The challenge of the display to a particular sterilization process should exceed the actual bioburden on the instrument to challenge this sterilization process. The challenge is microbes.

The number and combination of resistance. If there is reason to believe that the item to be treated may receive some kind of microbial contamination with special resistance, According to the bioburden situation, it is required to extend the sterilization process time.

4.7 Biological indicators are not used in sterilization processes other than those specified by the manufacturer on their product labels, biological indicator species and strain selection Based on the manufacturer's resistance to specific sterilization processes.

The user should ensure that the biological indicator has been confirmed and is suitable for the specific sterilization conditions used. For this reason, it may be necessary to provide some ratio labels More details are listed above. When the biological indicator is used to exceed the reference condition, the user may request that the relevant biological indicator may be issued.

Information on the raw reaction, such as suboptimal humidity condition effects when the biological indicator is used in the ethylene oxide sterilization process. Non-standard sterilization When biological indicators are used in the technology, the biological indicators should be fully described for their resistance to specific sterilization processes, and to a wide range of microorganisms.

Comparisons, including comparisons with various harmful microorganisms and vectors that may form part of the bioburden of the product. Biological indicator and The correspondence of process parameters should be demonstrated clearly.

4.8 Sterilize the product to ensure that the type of biological indicator is suitable for confirmation and/or routine monitoring of a particular sterilization process.

4.9 Manufacturer's recommendations for the use and storage of biological indicators should always be followed. Otherwise, the perfection of the biological indicator cannot be guaranteed.

If the infected carrier is removed from the inner packaging of the biological indicator by the user, its resistance characteristics may change. Therefore, should be from the manufacturer Obtain information about the extent of this change, otherwise the user should determine the specific change in resistance. The user should specify what the dye carrier has. The performance characteristics are suitable for adoption.

4.10 Biological indicators should not be used if they are in the expiration date specified by the manufacturer.

4.11 Users who confirm and/or routinely sterilize with biological indicators should be well trained in the use of biological indicators. Extinguish The time between the completion of the bacterial process and the biomarker test shall be adjusted as specified in 8.2.4. Sterile technology should be used to sterilize The treated microorganisms are transferred to a suitable resuscitation medium.

4.12 ISO 11138 specifies the requirements for the description of biological indicators provided by the manufacturer. The form of the manual can be a label, a small package Clip pages or general technical specifications, sent along with biological indicators. The standard also includes minimum requirements for resistance characteristics. Test strip given Both the parts and methods are reference methods.

4.13 Biometrics users come from a variety of industrial sectors, private companies and health care institutions. Usually, these users are not required to enter Conducting resistance tests for biological indicators, but there are different requirements for their respective quality assurance systems, including for sellers and/or manufacturing Business review (see 6.2.2).

4.14 If necessary, the user shall verify the resistance characteristics, which is a method of replacing the audit and/or the auxiliary audit.