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Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 18281.1-2024: Sterilization of health care products - Biological indicators - Part 1: General requirements Status: Valid GB/T 18281.1: Historical versions
Basic dataStandard ID: GB/T 18281.1-2024 (GB/T18281.1-2024)Description (Translated English): Sterilization of health care products - Biological indicators - Part 1: General requirements Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 38,345 Date of Issue: 2024-11-28 Date of Implementation: 2025-12-01 Older Standard (superseded by this standard): GB 18281.1-2015 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 18281.1-2024: Sterilization of health care products - Biological indicators - Part 1: General requirements---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 Replaces GB 18281.1-2015 Sterilization biological indicators for healthcare products Part 1.General Part 1.General requirements Released on 2024-11-28 2025-12-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General production requirements 4 5 Specific production requirements 6 6 Determination of bacterial count and resistance 7 7 Culture conditions 9 Appendix A (Normative) Determination of viable bacteria 10 Appendix B (Normative) Determination of growth inhibition of carriers and primary packaging materials after sterilization process 11 Appendix C (Normative) Survival curve method for determining D value 13 Appendix D (Normative) Determination of D value by partial negative analysis 16 Appendix E (Normative) Survival and killing response characteristics 27 Appendix F (informative) Relationship of components of biological indicators 28 References 29ForewordThis 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 1 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 18281.1-2015 "Biological indicators for sterilization of health care products Part 1.General principles" and GB 18281.1- Compared with.2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Deleted the terms and definitions of "FBIO value" and "packaging system" (see Chapter 3 of the.2015 edition); --- Added the cultivation in the final product requirements (see 4.1.3); --- Deleted the requirements for the number of test microorganisms (see 4.2.3.2 of the.2015 version); --- Deleted the labeling requirements (see 4.3.3 of the.2015 version); --- Added relevant requirements for biological indicator detection instruments (see 4.3.3 and 4.3.4); --- Changed the requirements for carriers, primary and secondary packaging (see 5.2, 5.2 of the.2015 edition); --- Changed the general resistance requirements (see 6.1.2 and 6.4.3, 6.1.2 and 6.4.3 of the.2015 edition); --- Added requirements for software validation and detection systems (see 7.4 and 7.5); --- Increased the number and requirements of test specimens (see Appendix B). This document is equivalent to ISO 11138-1.2017 "Biological indicators for sterilization of health care products Part 1.General principles". 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. Shandong Xinhua Medical Instrument Co., Ltd., 3M China Co., Ltd., Guangdong Medical Device Quality Supervision Laboratory, Johnson & Johnson (Suzhou) Medical Devices Co., Ltd., Terumo Medical Products (Hangzhou) Co., Ltd., Chinese Academy of Medical Sciences and Peking Union Medical College Hospital Institute, Zhongguancun International Pharmaceutical Inspection and Certification Technology Co., Ltd. The main drafters of this document are. Zhao Shuaishuai, Lin Manting, Hu Changming, Liang Zexin, Huang Jingxiong, Liu Xuemei, Weng Hui, Zhang Qing, Su Yuxin, Wu Yangyang, Li Mengjie, Han Jiankang, and Lu Fangbin. The previous versions of this document and the documents it replaces are as follows. ---First published in.2000 as GB 18281.1-2000; ---First revised in.2015; ---This is the second revision.IntroductionGB/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, and methods for shortening the incubation time. It consists of 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 for selection, use and result interpretation. The purpose is to provide guidance for the correct selection and use of biological indicators. --- 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 specifies the use of biological indicators (including contaminated carriers and bacterial suspensions) in production, labeling, testing, and sterilization process validation and monitoring. The other parts of GB/T 18281 provide other requirements for biological indicators used in different sterilization processes. He made specific requests. Table F.1 introduces the detailed diagram and components of biological indicators. GB/T 18281 contains two types of biological indicators in the description. This indicates that the contaminated carrier can be exposed to sterilizing factors without packaging or with a primary packaging that can be penetrated by the sterilizing substance. The resistance characteristics depend on the type of test microorganisms, their quantity, the method of preparation, the substrate inoculated, the environmental conditions of inoculation and drying, and the primary Influence of packaging. For the selection, use and interpretation of results of biological indicators, see ISO 11138-7. For any independent sterilization process (including those described in other parts of GB/T 18281), the resistance of the biological indicator also depends on Theoretically, this could lead to significant changes in the preparation of biological indicators. In addition, the sterilization process can An infinite variety of operations can be performed to accommodate every set of conditions to which the product may be exposed. It has become common practice to specify the resistance properties of biological indicators produced in the presence of D values and associated z values. This is described in other parts of GB/T 18281. Experts representing professional manufacturers, users and authoritative management departments participated in the development of Parts 1 to 5 of GB/T 18281. Drafted, it represents the current level of technological development. Biological indicators for specific sterilization processes not covered in other parts of GB/T 18281 should also follow the general provisions of GB/T 18281. Such indicators cannot be precisely defined and may be used for new sterilization processes or for individual microorganisms. If these biological indicators contain microorganisms outside the WHO risk assessment group, they must meet appropriate preservation requirements. Method and security level. Existing standards provide requirements for the validation and control of sterilization processes (see References). Sterilization biological indicators for healthcare products Part 1.General1 ScopeThis document specifies biological indicators (including contaminated carriers, test bacterial suspensions) and other components intended to be used to confirm and monitor sterilization cycles. Some general requirements for production, marking, test methods and performance. The basic requirements of this document apply to all parts of GB/T 18281. The requirements are specified in the relevant parts of GB/T 18281.This document is applicable to biological indicators without special requirements. Note. Regulations in some countries or regions may apply. This document is not applicable to test systems that rely on physical removal of microorganisms, such as filtration processes or the use of washer-disinfectors or circulating steam. Processes that inactivate microorganisms by physical and/or mechanical methods such as steam, however, this document may contain content related to microbiological test systems.2 Normative referencesThe contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB/T 19973.1-2023 Microbiological methods for sterilization of health care products Part 1.Determination of the total number of microorganisms on the product (ISO 11737-1.2018, IDT) Note. There is no technical difference between the referenced content of GB/T 19973.1-2023 and the referenced content of ISO 11737-1.2016. ISO 11135 Sterilization of healthcare products - Requirements for the development, validation and routine control of ethylene oxide sterilization processes for medical devices Note. GB 18279-2023 Sterilization of healthcare products - Development, validation and routine control requirements for ethylene oxide sterilization processes for medical devices (ISO 11135.2014, MOD) ISO 11138-2 Biological indicators for sterilization of health care products Part 2.Biological indicators for ethylene oxide sterilization Note. GB/T 18281.2-2024 Biological indicators for sterilization of health care products Part 2.Biological indicators for ethylene oxide sterilization (ISO 11138- 2.2017,IDT) ISO 11138-3 Biological indicators for sterilization of health care products Part 3.Biological indicators for moist heat sterilization Note. GB/T 18281.3-2024 Biological indicators for sterilization of health care products Part 3.Biological indicators for moist heat sterilization (ISO 11138-3. 2017, IDT) ISO 11138-4 Biological indicators for sterilization of health care products Part 4.Biological indicators for dry heat sterilization Note. GB/T 18281.4-2024 Biological indicators for sterilization of health care products Part 4.Biological indicators for dry heat sterilization (ISO 11138-4. 2017, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 18281.1-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 18281.1-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 18281.1-2024_English with my colleagues?Answer: Yes. 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