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Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 18282.1-2025: Sterilization of health care products - Chemical indicators - Part 1: General requirements Status: Valid GB/T 18282.1: Historical versions
Basic dataStandard ID: GB/T 18282.1-2025 (GB/T18282.1-2025)Description (Translated English): Sterilization of health care products - Chemical 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: 30,359 Date of Issue: 2025-01-24 Date of Implementation: 2026-02-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 18282.1-2025: Sterilization of health care products - Chemical 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 18282.1-2015 Chemical indicators for sterilization of healthcare products Part 1.General Part 1.General requirements Released on 2025-01-24 2026-02-01 implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Categories 3 5 General requirements 4 6 Performance Requirements 6 7 Test Methods 7 8 Additional requirements for process (class I) indicators 9 9 Additional requirements for indicators of single key process variables (category 3) 11 10 Additional requirements for indicators of multiple key process variables (four categories) 11 11 Additional requirements for steam integration (category 5) indicators 12 12 Additional requirements for ethylene oxide integration (class V) indicators 12 13 Additional requirements for simulated (class VI) indicators 13 Appendix A (Normative) Methods for Proving Product Validity Period 14 Appendix B (informative) Examples of test indicators 15 Annex C (informative) Rationale for the requirements for integrated indicators and their relevance to biological indicators specified in ISO 11138 (all parts) Requirements and relevance to microbial inactivation16 Appendix D (Informative) Principle of Low Temperature Vapor Formaldehyde Indicator Liquid Phase Test Method 21 Appendix E (Informative) Relationship between indicators and indicator systems 22 Reference 23ForewordThis 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 18282 "Chemical indicators for sterilization of health care products". GB/T 18282 has been published The following parts. --- Part 1.General; --- Part 3.Type II indicator system for BD type vapor penetration test; --- Part 4.Class II indicators for alternative BD-type vapor permeation tests; --- Part 5.Type II indicators for BD type air discharge tests. Note. GB/T 18282.2 “Test Equipment and Methods for Sterilization Chemical Indicators of Health Care Products” has been replaced by GB/T 24628-2009 “Test Equipment and Methods for Sterilization Chemical Indicators of Health Care Products”. It is replaced by the "Bacteria Biological and Chemical Indicator Test Equipment". This document replaces GB 18282.1-2015 "Chemical indicators for sterilization of health care products Part 1.General principles" and GB 18282.1- Compared with.2015, in addition to structural adjustments and editorial changes, the main technical changes are as follows. --- Changed "Scope" (see Chapter 1, Chapter 1 of the.2015 edition); --- Added the term and definition of "exposure period" (see 3.4); --- Changed the terms and definitions of "key process variables", "indicators" and "process parameters" (see 3.2, 3.7, 3.10, 3.2, 3.7, 3.10 of the.2015 edition) 3.6, 3.9); --- Changed "Classification" (see 4.1, 4.3~4.7, 4.1, 4.3~4.7 of the.2015 edition); --- Changed the "General requirements" (see 5.2, 5.4, 5.6, 5.7, 5.8, 5.2, 5.4, 5.6, 5.7, 5.8 of the.2015 edition); --- Changed "Performance Requirements" (see Chapter 6, Chapter 6 of the.2015 edition); --- Changed the "Test Method" (see Chapter 7, Chapter 7 of the.2015 edition); --- Changed "Process indicators for steam sterilization process" (see 8.2, 8.2 of the.2015 edition); --- Changed "Process indicators for ethylene oxide sterilization process" (see 8.4, 8.4 of the.2015 edition); --- Changed "Process indicators for radiation sterilization processes" (see 8.5, 8.5 of the.2015 edition); --- Changed the "Additional requirements for indicators of single key process variables (category 3)" (see Chapter 9, Chapter 9 of the.2015 edition); --- Changed the "Additional requirements for indicators of multiple key process variables (four categories)" (see Chapter 10, Chapter 10 of the.2015 edition); --- Changed the "Additional requirements for steam integration (category 5) indicators" (see Chapter 11, Chapter 11 of the.2015 edition); --- Deleted "Additional requirements for dry heat integration (category 5) indicators" (see Chapter 12 of the.2015 edition); --- Changed the "Additional requirements for indicators of ethylene oxide integration (category 5)" (see Chapter 12, Chapter 13 of the.2015 edition); --- Changed the nature of Appendix A from informative to normative (see Appendix A of the.2015 edition). This document is equivalent to ISO 11140-1.2014 "Chemical 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., Guangdong Medical Instrument Quality Supervision and Inspection Institute, China Medical Science Peking Union Medical College Hospital, Beijing Jikayi Technology Co., Ltd., Xinxiang Huaxi Medical Materials Co., Ltd., Zhongguancun International Medical Inspection and Certification Department TECHNOLOGY LIMITED. The main drafters of this document are. Zhao Kelong, Cheng Juan, Zhang Qing, Guo Wei, Cui Wenbo, Hou Jimin, Zhong Shan, Zhao Huaihua, Yun Yong, and Su Yuxin. The previous versions of this document and the documents it replaces are as follows. ---First published in.2000 as GB 18282.1-2000; --- Revised for the first time in.2015 to GB 18282.1-2015; ---This is the second revision.IntroductionGB/T 18282 "Chemical Indicators for Sterilization of Health Care Products" is the basic and universal standard for chemical indicators in my country. GB/T 18282 aims to establish the performance requirements and/or test methods for indicators and indicator systems and is intended to consist of four parts. --- Part 1.General. The purpose is to establish the performance requirements and (or) test methods of chemical indicators. --- Part 3.Type II indicator system for BD type steam penetration test. The purpose is to establish a type II indicator system for BD type steam penetration test. Performance testing of sterilizers used for the sterilization of packaged and porous loads using a Class II indicator system. --- Part 4.Class II indicators for alternative BD-type steam permeation tests. The Class II indicator system for vapor permeation testing is a performance test for sterilizers used for the sterilization of packaged and porous loads. --- Part 5.Class II indicators for BD type air exhaust tests. The purpose is to establish the indicators for BD type air exhaust tests. Class II indicators are used to evaluate the air removal effect during the pre-vacuum stage of the pre-vacuum sterilization cycle. This document specifies the performance requirements and/or test methods for chemical indicators intended for use in steam, dry heat, ethylene oxide, Testing of sterilization processes using gamma or beta radiation, low temperature steam formaldehyde, or vaporized hydrogen peroxide. For indicators intended for use with other sterilization methods (e.g. other forms of moist heat sterilization) for which this document does not specifically provide additional requirements, The general requirements of this document will apply. Requirements for specific test indicators (such as BD test indicators and indicator systems) are included in other parts of GB/T 18282. part. Standards for sterilizers and for sterilization process control and validation, describing the performance test and routine control and validation of sterilizers, respectively. method. This document is intended for use by manufacturers of chemical indicators and specifies general principles for chemical indicators. Subsequent parts of GB/T 18282 specify The standard specifies chemical indicators for specific uses and specific requirements for testing of specific sterilization processes for healthcare products, including industrial sterilization. There is no hierarchical meaning for the classification. The chemical indicators described in this document are divided into six categories. Each type of chemical indicator is classified according to its use. This document defines the requirements for Class I, Class III, to Class VI indicators. The requirements for indicators are divided into subsequent parts of GB/T 18282 according to their uses. Indicators and indicator systems specified in this document The uses of are described in ISO 11135, ISO 17665 series, ISO 15882, EN285 and EN13060. In addition to type II indicators, resistometers are used to test the performance of chemical indicators described in this document. The requirements for resistometers are given in ISO 18472. The resistance meter is different from the conventional sterilizer. Since the sterilizer cannot replicate the conditions of the resistance meter, the sterilizer is not suitable for testing chemical indicators. Sterilizers from different manufacturers and from different eras have significantly different cycle characteristics; for example, extended pre-treatment In order to study the effect of process parameters on the performance of the indicator under controlled and repeatable conditions, the resistometer needs to accurately control the specific measurement conditions. Guidance on the selection, use and interpretation of chemical indicator results is given in ISO 15882. document. Chemical indicators for sterilization of healthcare products Part 1.General WARNING. Use of this document may involve hazardous materials, procedures, and equipment. This document does not purport to address all safety concerns associated with its use. It is the responsibility of the user of this document to determine the applicability of national or regional regulatory requirements and to Establish appropriate occupational health and safety practices before installing equipment.1 ScopeThis document specifies general requirements and test methods for indicators that indicate their presence by physical and/or chemical changes in substances. They are exposed to the sterilization process and are used to monitor whether specific single or multiple process parameters are met during the sterilization process. The existence or non-existence of an object is not directly related. Note 1.Biological test systems rely on the demonstration of the viability of organisms to perform the test. (BIs) involved. This document applies to all indicators specified in other parts of GB/T 18282.In addition to the requirements modified or added in other parts, this The requirements of the specific part will apply. If other parts have modified or added requirements, the modified or added requirements will also apply. Applicable. The relevant test equipment is described in ISO 18472. NOTE 2 Additional requirements for specific test indicators/indicator systems (Type II) are given in ISO 11140-3, ISO 11140-4 and ISO 11140-5.2 Normative referencesThe contents of the following documents constitute the 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. change) ISO 11135 Sterilization of healthcare products Requirements for the development, validation and routine control of ethylene oxide sterilization processes for medical devices tion) heat Note. GB/T 24628-2025 Sterilization biological and chemical indicator test equipment for healthcare products (ISO 18472.2018, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 18282.1-2025_English be delivered?Answer: Upon your order, we will start to translate GB/T 18282.1-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 18282.1-2025_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 18282.1-2025_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. 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