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GB/T 19972-2018: Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
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PDF similar to GB/T 19972-2018
Standard similar to GB/T 19972-2018 GB/T 19973.2 GB/T 19633.2 GB/T 19973.1 Basic data | Standard ID | GB/T 19972-2018 (GB/T19972-2018) | | Description (Translated English) | Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 54,545 | | Date of Issue | 2018-03-15 | | Date of Implementation | 2018-10-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 19972-2018: Sterilization of health care products -- Biological indicators -- Guidance for the selection, use and interpretation of results
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Sterilization of health care products--Biological indicators--Guidance for the selection, use and interpretation of results
ICS 11.080.01
C47
National Standards of People's Republic of China
Replace GB/T 19972-2005
Health care product sterilization biological indicator
Choice, use, and results judgment guide
(ISO 14161.2009, IDT)
Published on.2018-03-15
2018-10-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Administration issued
Content
Foreword I
Introduction II
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 General 5
5 biological indicator characteristics 6
6 supplier selection 8
7 Biological indicators in process development 9
8 Sterilization confirmed biological indicators 11
9 Biological indicators in routine monitoring 12
10 result 13
11 Application of biological indicator standards 14
12 Culture conditions 19
13 Requirements for third parties 21
14 Staff Training 21
15 Storage and management 22
16 Biological Indicator Processing 22
Appendix A (informative) Microbial inactivation mechanics and counting methods 23
Appendix B (informative) Process Challenge Device 27
Appendix C (informative) Partial negative method for determining D value 28
Appendix D (informative) Example of a transcript of a biological indicator prepared by the user 40
Appendix E (informative) Calculation of z-values 44
Appendix F (informative) Survival curve method measures D value 46
Appendix G (informative) Survival-killing response characteristics 49
Reference 50
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)
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200).
This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Beijing Jikayi Technology Co., Ltd., 3M China Co., Ltd.
The main drafters of this standard. Wu Weirong, Qian Yingjie, Zhang Yang, Huang Jingxiong.
The previous versions of the standards replaced by this standard are.
---GB/T 19972-2005.
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.
sequence. 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.
Health care product sterilization biological indicator
Choice, use, and results judgment guide
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.
guide. 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 article.
Pieces. 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)
Biomedical products - Sterilization of biological indicators - Part 4. Sterilization for dry heat sterilization
ofhealthcareproducts-Biologicalindicators-Part 4.Biologicalindicatorsfordryheatsterilization
Processes)
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.
3.1
Accreditation accreditation
Formally indicate that the conformity assessment body has a third-party certificate for the ability to perform specific conformity assessment work.
Note 1. See ISO /IEC 17011 [3].
Note 2. Accreditation itself does not confirm that the laboratory has the qualification to approve a product, but when the approval and certification authority decides whether to adopt a specific laboratory
When it comes to data about its own activities, recognition is related to this.
3.2
Aseptic technique aseptictechnique
To rule out the conditions and methods used for microbial contamination.
3.3
Bioburden
The total number of viable microorganisms on the surface and/or inside of a product and/or sterile barrier system.
[ISO /T S11139, Definition 2.2]
3.4
Biological indicator biologicalindicator; BI
A test system containing viable microorganisms with defined resistance to a defined sterilization process.
[ISO /T S11139, Definition 2.3]
3.5
D value Dvalue
D10 value D10value
The time or dose required to inactivate 90% of the total number of test microorganisms under specified conditions.
[ISO /T S11139, definition 2.11]
3.6
Duration holdingtime
During a sterilization phase, the sterilization variables in the sterilizer and all locations within the load are maintained within the specified limits.
3.7
Bacteria carrier inoculatedcarrier
A vector that has been stained with the indicated number of test microorganisms.
Note 1. See ISO 11138-1.
Note 2. The test microorganism is a microorganism used for the production of the carrier for the infection.
3.8
Installation identification instalationqualification; IQ
The process of obtaining evidence and documenting evidence that the equipment has been provided and installed as required by the technical specifications.
[ISO /T S11139, definition 2.22]
3.9
Inoculation
A specified number of specific microbial entities are added to the interior or surface of the article.
3.10
Log reduction value logreduction; LR
The decrease in the number of viable microorganisms is expressed in units of lg.
3.11
Operational authentication operationalqualification; OQ
Obtain evidence and document the process of proving that the installed equipment is in the intended range when the equipment is used in accordance with the equipment operating procedures
Running inside.
[ISO /T S11139, definition 2.27]
3.12
Performance qualification performancequalification; PQ
Obtain evidence and document the process of proving that equipment that has been installed and operated according to the operating procedures will continue to be stable according to predetermined criteria
Produce products that meet the requirements of product specifications.
[ISO /T S11139, definition 2.30]
3.13
Process challenge device processchalengedevice; PCD
A device that constitutes a specific resistance to the sterilization process and is used to evaluate the effectiveness of the sterilization process.
[ISO /T S11139, definition 2.33]
3.14
Process challenge site processchalengelocation; PCL
It is possible to simulate a sterilization factor in a "most unfavorable state" position in a batch of items to be sterilized.
3.15
Process parameter processparameter
The specified value of the process variable.
Note. The specified values for the sterilization process include process parameters and their tolerances.
[ISO /T S11139, definition 2.34]
3.16
Process variable processvariable
Conditions within the scope of the sterilization process can change the effectiveness of the sterilization.
Examples. time, temperature, pressure, concentration, humidity, wavelength.
[ISO /T S11139, definition 2.35]
3.17
Reference microorganism referencemicroorganism
A microbial strain obtained by a recognized strain collection institution.
[ISO /T S11139, definition 2.39]
3.18
Resistance meter
Test equipment designed to produce a combination of physical and/or chemical variables during the sterilization process.
Note 1. According to ISO 11138-1, definition 3.15 and GB/T 24628-2009, definition 3.11.
Note 2. The biometric indicator resistance tester (BIER) is also referred to.
3.19
Spore log reduction value spore-log-reduction; SLR
The logarithm of the initial number of spores, N0, minus the logarithm of the final number of spores, NF.
3.20
Sterile sterile
No living microorganisms.
[ISO /T S11139, definition 2.43]
3.21
Sterility assurance level sterilityassurancelevel; SAL
The probability of a single living microorganism present on the product after sterilization.
Note. The term “SAL” is expressed in terms of magnitude and is usually 10-6 or 10-3. When applying this magnitude to the sterility assurance level, the 10-6 SAL has a lower
The value thus provides a greater level of sterility assurance than the 10-3 SAL.
[ISO /T S11139, definition 2.46]
3.22
Sterilization sterilization
A confirmed process for making the product free of viable microorganisms.
Note. During sterilization, the nature of microbial inactivation is exponential; thus the survival of microorganisms on a single product can be expressed in terms of probability. although
This probability can be reduced to very low, but it is impossible to drop to zero, see "Aseptic Assurance Level".
[ISO /T S11139, definition 2.47]
3.23
Sterilization cycle development sterilizationcycledevelopment
The process of determining the appropriate process parameters such that a known product or class of products achieves the desired ratings and label claims.
3.24
Sterilization cycle confirmation sterilizationcyclevalidation
Used to obtain, document, and describe results documenting procedures and to establish a sustainable production of products that meet expected technical specifications.
process.
3.25
Supplier supplier
The organization or individual that provided the product.
Examples. Manufacturers, wholesalers, retailers of products, or providers of vendors, services, or information.
Note 1. The supplier can be internal or external to the organization.
Note 2. The supplier sometimes becomes a “contractor” in the case of a contract.
[ISO 9000, Definition 3.3.6]
3.26
Survival-killing interval survival-kilwindow
When sterilized under the specified conditions, the biological indicator transitions from all living microorganisms (survival time) to all killed microorganisms (killing)
The degree of exposure of the time).
[ISO 11138-1, definition 3.18]
3.27
Third party thirdparty
An individual or institution that is recognized as independent of the parties involved in the issues involved.
Note 1. See ISO /IEC Guide 2 [1].
Note 2. The parties concerned are usually the supplier (first party) and the demander (second party).
3.28
User user
Individuals and institutions that use biological indicators for their intended use.
Note 1. See ISO 9000 [4].
Note 2. The customer is the customer of the product provided by the supplier. In the case of the contract, the user may be referred to as the “buyer”. The user can be a customer, a consignee or a buyer. user
It can be internal or external to the organization and represents the “second party”.
3.29
z value zvalue
The value of the exposure temperature required to vary the value of D by an order of magnitude during thermal sterilization.
Note. See ISO 11138-3 and ISO 11138-4.
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.
5 Biological indicator characteristics
5.1 Overview
5.1.1 Biological indicators pr...
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