GB/T 18281.2-2024 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 18281.2-2024: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes Status: Valid GB/T 18281.2: Historical versions
Basic dataStandard ID: GB/T 18281.2-2024 (GB/T18281.2-2024)Description (Translated English): Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 10,195 Date of Issue: 2024-11-28 Date of Implementation: 2025-12-01 Older Standard (superseded by this standard): GB 18281.2-2015 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 18281.2-2024: Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide 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 18281.2-2015 Sterilization biological indicators for healthcare products Part 2.Biological indicators for ethylene oxide sterilization (ISO 11138-2.2017,IDT) 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 1 4 General requirements 1 5 Test microorganisms 1 6 Bacterial suspension 2 7 Carrier and primary packaging 2 8 Contaminated carriers and biological indicators 2 9 Bacterial count and resistance 2 Appendix A (Normative) Method for determination of resistance of biological indicators for ethylene oxide sterilization 3 Appendix B (informative) Specification for the introduction of a second minimum D value for changes in test gas for assessing resistance and deletion of the minimum D value at 30 °C Reason for request 4 References 5ForewordThis 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 2 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 18281.2-2015 "Biological indicators for sterilization of health care products Part 2.Biological indicators for ethylene oxide sterilization" Compared with GB 18281.2-2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Deleted the way in which the D value at 30℃ represents resistance (see 9.4 of the.2015 edition); --- Deleted the requirement that the D value should be ≥ 12.5min at 30℃ (see 9.5 of the.2015 edition); --- Deleted the description that the resistance of biological indicators can be expressed as FBIO (see 9.6 of the.2015 edition); --- Added the D value requirements when testing with mixed gas and 100% ethylene oxide gas (see 9.5 and 9.6). This document is equivalent to ISO 11138-2.2017 "Biological indicators for sterilization of health care products Part 2.Biological indicators for sterilization with ethylene oxide" Biological Indicators. 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. Lingbo Medical (Hangzhou) Medical Technology Co., Ltd., Shandong Xinhua Medical Equipment Co., Ltd., Xinxiang Huaxi Medical Materials Co., Ltd., 3M China Co., Ltd., Guangdong Medical Device Quality Supervision and Inspection Institute, Hangzhou Unik Disinfection Equipment Co., Ltd. Company, Hangzhou Fujie Disinfection Products Co., Ltd. The main drafters of this document are. Zhou Zhilong, Zhao Jianing, Lin Manting, Cui Wenbo, Zhou Guangyu, Hu Bin, Huang Jingxiong, Wang Zhijing, and Wang Qiang. The previous versions of this document and the documents it replaces are as follows. ---First issued as GB 18281.2-2000 in.2000 and 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, 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 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 production, labeling, test methods and performance requirements of biological indicators, which include This document specifies the specifications for biological indicators used in ethylene oxide sterilization processes. Use requirements. This document was developed by experts representing manufacturers, users and regulatory authorities. The present document does not recommend the use of biological indicators in situations where they are currently in use, but rather provides specifications for biological indicators currently in use. Requirements for ethylene oxide sterilization validation and routine control are given in ISO 11135 and ISO 14937. Guidance on the selection, use and result judgment of biological indicators is given in GB/T 18281.7. Sterilization biological indicators for healthcare products Part 2.Biological indicators for ethylene oxide sterilization1 ScopeThis document specifies the test microorganisms, bacterial suspensions, contaminated carriers, biological indicators, and The sterilizer and sterilization process use pure ethylene oxide gas or a mixture of ethylene oxide gas and diluent gas. The sterilization temperature range is 29℃~65℃. Note 1.For the requirements for ethylene oxide sterilization validation and control, see ISO 11135 and 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 purpose of this document, the terms and definitions given in ISO 11138-1 apply. The terminology databases used for standardization maintained by ISO and IEC are located at.4 General requirementsThe requirements of ISO 11138-1 apply.5 Test microorganisms5.1 The test microorganisms shall be Bacillus atrophaeus spores, Bacillus subtilis spores or other microorganisms with equivalent performance that have been shown to meet the requirements of this document. Microbial strains. Note 1.Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus. Note 2.Bacillus atrophaeus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and ICP77.18 have been found to be suitable Suitable strains 1). 1) Bacillus atrophaeus ATCC9372, NCTC10073, NCIMB8058, DSM2277, NRRLB-4418 and CIP77.18 are suitable commercially available This information is given for the convenience of users of this document and does not constitute an endorsement of these products. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 18281.2-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 18281.2-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 18281.2-2024_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 18281.2-2024_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version GB/T 18281.2-2024?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 18281.2-2024 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
