GB/T 18281.7-2024 English PDF

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GB/T 18281.7-2024: Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results
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Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 18281.7-2024	1084	Add to Cart	8 days	Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results	Valid

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Basic data

Standard ID: GB/T 18281.7-2024 (GB/T18281.7-2024)
Description (Translated English): Sterilization of health care products - Biological indicators - Part 7: 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: 54,535
Date of Issue: 2024-09-29
Date of Implementation: 2025-10-01
Older Standard (superseded by this standard): GB/T 19972-2018
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 18281.7-2024: Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.080.01 CCSC47 National Standard of the People's Republic of China Replace GB/T 19972-2018 Sterilization biological indicators for healthcare products Part 7.Guidance for selection, use and interpretation of results (ISO 11138-7.2019, IDT) Released on 2024-09-29 2025-10-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Table of Contents

Preface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General 4 5 Characteristics of biological indicators 5 6 Supplier selection 7 7 Biological Indicators in Process Development 8 8 Biological indicators for sterilization confirmation 10 9 Biological indicators in routine monitoring11 10 Judgment and Acceptance Criteria 12 11 Application of Biological Indicator Standards 13 12 Culture conditions 18 13 Requirements for third parties (Third-party considerations) 19 14 Staff training20 15 Storage and handling 20 16 Handling of biological indicators 20 Appendix A (Informative) Microbial inactivation kinetics and counting techniques 21 Appendix B (Informative) Process Challenge Device 25 Appendix C (Informative) Determination of D value by partial negative analysis 26 Appendix D (Informative) Example of User-Prepared Documentation for Biological Indicators 38 Appendix E (Informative) Calculation of z-value 42 Appendix F (Informative) Determination of D value by survival curve method 44 Appendix G (Informative) Survival and Killing Response Characteristics 47 References 48

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is part 7 of GB/T 18281 "Biological indicators for sterilization of healthcare products". GB/T 18281 has been published The following parts. --- Part 1.General; --- Part 2.Biological indicators for ethylene oxide sterilization; --- Part 3.Biological indicators for moist heat sterilization; --- Part 4.Biological indicators for dry heat sterilization; --- Part 5.Biological indicators for low temperature steam formaldehyde sterilization; --- Part 7.Guidance for selection, use and result judgment; --- Part 8.Confirmation method for shortening the incubation time of biological indicators. This document replaces GB/T 19972-2018 "Guidelines for the selection, use and result judgment of biological indicators for sterilization of medical products" Compared with GB/T 19972-2018, in addition to structural adjustments and editorial changes, the main technical differences are as follows. --- Changed the contents not specifically specified in this document (see Chapter 1, Chapter 1 of the.2018 edition); --- Deleted some terms and definitions (see Chapter 3, Chapter 3 of the.2018 edition) --- Added the content of self-contained biological indicators (see Chapter 4); --- Deleted other indicators (see 5.5 of the.2018 edition); --- Changed the relevant content of supplier selection (see Chapter 6, Chapter 6 of the.2018 edition); --- Changed the relevant content of biological indicators in process development (see Chapter 7, Chapter 7 of the.2018 edition); --- Changed the relevant content of the treatment of biological indicators (see Chapter 16, Chapter 16 of the.2018 edition). This document is equivalent to ISO 11138-7.2019 "Biological indicators for sterilization of health care products - Part 7.Selection, use and conclusion" Results Judgment Guide. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Disinfection Technology and Equipment (SAC/TC200). This document was drafted by. Terumo Medical Products (Hangzhou) Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Ruixikang (Suzhou Suzhou) Medical Technology Co., Ltd., Shaoxing Fuqing Hygiene Products Co., Ltd., Jiaxing Gaoshi Sterilization Technology Co., Ltd., Johnson & Johnson (Suzhou) Medical Devices Ltd. The main drafters of this document are. Weng Hui, Wu Weirong, Zhong Jing, Lin Manting, Liu Xuemei, Hu Jiajun, Liu Yinghong and Liu Wenyi. The previous versions of this document and the documents it replaces are as follows. ---First published in.2005 as GB/T 19972-2005; ---First revised in.2018;

Introduction

GB/T 18281 "Biological Indicators for Sterilization of Healthcare Products" is a general and specific standard for biological indicators. GB/T 18281 aims to provide requirements for biological indicators, guidelines for selection, use and result judgment, as well as methods for shortening the incubation time. It consists of eight parts. --- Part 1.General. The purpose is to provide general requirements for biological indicators. --- Part 2.Biological indicators for ethylene oxide sterilization. The purpose is to provide a dedicated biological indicator for ethylene oxide sterilization Require. --- Part 3.Biological indicators for moist heat sterilization. The purpose is to provide specific requirements for biological indicators for moist heat sterilization. --- Part 4.Biological indicators for dry heat sterilization. The purpose is to provide specific requirements for biological indicators for dry heat sterilization. --- Part 5.Biological indicators for low temperature steam formaldehyde sterilization. The purpose is to provide biological indicators for low temperature steam formaldehyde sterilization Special requirements for --- Part 6.Biological indicators for hydrogen peroxide sterilization. The purpose is to provide a dedicated biological indicator for hydrogen peroxide sterilization Require. --- Part 7.Guidance on selection, use and result interpretation. The purpose is to provide guidance on the correct selection, use and result interpretation of biological indicators. Broken guide. --- Part 8.Confirmation method for shortening the incubation time of biological indicators. The purpose is to provide a method for shortening the incubation time of biological indicators. Confirmation method. This document provides guidance on the selection, use and interpretation of biological indicators when applied to the development, validation and monitoring of sterilization processes. The steps described in this document are of a general nature and are not intended by themselves to be a comprehensive process for the development, validation, and monitoring of sterilization of healthcare products. The purpose of this document is not to mandate the use of biological indicators in a process, but rather to provide guidance on the correct selection of biological indicators if they are used. provide guidance for selection and use to avoid misleading results. In this document, biological indicator users (hereinafter referred to as users) can obtain biological indicators for specific sterilization processes and key parameters. Guidelines for selecting indicators and for the correct use of such indicators. Users should select biological indicators that are appropriate for the specific sterilization process they are using. It is difficult for a manufacturer of a biological indicator (hereinafter referred to as the manufacturer) to foresee all possible uses of its products. Therefore, the manufacturer can only mark its biological indicator for use in a certain Specific use. The appropriate selection, use, recovery and interpretation of the results for the specific sterilization process employed should be the responsibility of the user. Storage and transport conditions before use of biological indicators, use of biological indicators, or sterilizer process parameters may affect the biological indicators. In addition, exposure to post-process culture techniques, including culture temperature, culture medium type, manufacturer, and specific batches, may also affect Therefore, the manufacturer's recommendations for storage and use should be followed. Materials should be transferred aseptically (if applicable) and cultured as specified by the manufacturer. It should be pointed out that biological indicators are not used to indicate that the sterilized items are indeed sterile, but to test a known sterilization process and the The effectiveness of sterilization equipment is evaluated by the principle of evaluating the lethality of microorganisms according to the sterility assurance level. The study should be conducted by appropriately trained personnel. NOTE. This document provides general information that also applies to processes and biological indicators not covered by current national standards, such as new and under-development sterilization process. Sterilization biological indicators for healthcare products Part 7.Guidance for selection, use and interpretation of results

1 Scope

This document provides guidance on the selection, use, and interpretation of biological indicators for the development, validation, and routine monitoring of sterilization processes. Guide. This document applies to all biological indicators. This document does not consider processes that rely solely on physical means to remove microorganisms, such as filtration. This document is not applicable to the use of combined processes such as flushing and steaming of washer-disinfectors or pipes. This document does not specify biodecontamination equipment for use in monitoring vaporized hydrogen peroxide processes at atmospheric pressure for isolator and room biodecontamination processes. Requirements for the selection and use of indicators. This document is not applicable to liquid immersion sterilization processes.

2 Normative references

This document has no normative references.

3 Terms and definitions

The following terms and definitions apply to this document. ISO and IEC maintain terminology databases for standardization at the following URLs. 3.1 Aseptic technique Conditions and procedures used to minimize the risk of introduction of microbiological contamination. [Source. ISO 11139.2018, 3.16] 3.2 Bioburden The total number of viable microorganisms on or within the surface of a product and/or sterile barrier system. [Source. ISO 11139.2018, 3.23] 3.3 biological indicator; BI A test system containing live microorganisms with defined resistance to a specified sterilization process. [Source. ISO 11139.2018, 3.29] 3.4 D value D10 value The time or dose required to inactivate 90% of the total number of test microorganisms under specified conditions. [Source. ISO 11139.2018, 3.75] ......

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