GB/T 18281.5-2024 English PDFUS$194.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 18281.5-2024: Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Status: Valid GB/T 18281.5: Historical versions
Basic dataStandard ID: GB/T 18281.5-2024 (GB/T18281.5-2024)Description (Translated English): Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 10,119 Date of Issue: 2024-11-28 Date of Implementation: 2025-12-01 Older Standard (superseded by this standard): GB 18281.5-2015 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 18281.5-2024: Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes---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 18281.5-2015 Sterilization biological indicators for healthcare products Part 5.Biological indicators for low temperature steam formaldehyde sterilization (ISO 11138-5.2017, IDT) Released on 2024-11-28 2025-12-01 Implementation State Administration for Market Regulation The National Standardization Administration issued ForewordThis 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 5 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 18281.5-2015 "Biological indicators for sterilization of health care products Part 5.Low temperature steam formaldehyde sterilization" Compared with GB 18281.5-2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Deleted the provisions for indicating the resistance of the object expressed by the FBIO value (see 9.6 of the.2015 edition). This document is equivalent to ISO 11138-5.2017 "Biological indicators for sterilization of health care products - Part 5.Low temperature steam formaldehyde sterilization" "Biological Indicators for Bacteria". The following minimal editorial changes were made to this document. --- Added note in A.1. Some 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. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Xinhua Medical Device Co., Ltd., Beijing Jikayi Technology Co., Ltd., Zhejiang Tailin Life Sciences Co., Ltd., and the First Affiliated Hospital of Sun Yat-sen University. The main drafters of this document are. Liang Zexin, Xu Suhua, Ye Xiaoyan, Liu Heng, Lin Manting, Cai Jiaman, Wang Qiang, Guo Wei, Gao Kaifei, and Du Heying. The previous versions of this document and the documents it replaces are as follows. ---First published in.2015 as GB 18281.5-2015; ---This is the first 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 process. The purpose is to provide a special Use requirements. --- 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. GB/T 18281.1 specifies the general requirements for the production, labeling, test methods and performance of biological indicators. Intended for use in sterilization process validation and routine monitoring of bacterial carriers and suspensions. This document specifies the low temperature steam formaldehyde sterilization process Particular requirements for biological indicators. GB/T 18281 was developed by experts from manufacturers, users and regulatory agencies. It does not recommend the use of biological indicators in certain situations, but rather provides standardized requirements for the production and use of biological indicators. ISO 25424 provides general requirements for the validation and routine monitoring of low-temperature steam formaldehyde sterilization processes. Note. my country has published standards covering sterilization or biological indicator requirements. Guidance on the selection, use and interpretation of biological indicators is given in GB/T 18281.7. Sterilization biological indicators for healthcare products Part 5.Biological indicators for low temperature steam formaldehyde sterilization1 ScopeThis document specifies the test microorganisms, bacterial suspensions, and contaminated solutions intended to be used to evaluate the performance of a sterilization process using low temperature steam formaldehyde as a sterilizing agent. Requirements for carriers, biological indicators and test methods. Note 1.The requirements for validation and routine control of low-temperature steam formaldehyde sterilization processes are given in ISO 14937. Note 2.Regulations in some countries or regions may give safety requirements for the workplace.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 18281.1-2024 Biological indicators for sterilization of healthcare products Part 1.General principles (ISO 11138-1.2017, IDT)3 Terms and definitionsFor the purposes of this document, the terms and definitions defined in ISO 11138-1 and the following apply. The terminology databases used for standardization maintained by ISO and IEC are located at. 3.1 Through powered exhaust, the pre-packaged items are exposed to steam under negative pressure, and formaldehyde gas is injected at a temperature below 100°C. The process by which the sterilant remains in a stable state during the maintenance time.4 General requirementsThe requirements of ISO 11138-1 apply.5 Test microorganisms5.1 The test microorganism shall be Geobacillus stearothermophilus or other microbial strains that have been shown to meet the requirements of this document for equivalent performance. Note 1.Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus. Note 2.Currently considered applicable Bacillus stearothermophilus include NCIB8224, DSM 6790, ATCC7593, ATCC10149 and ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 18281.5-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 18281.5-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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