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Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0970-2023: Sterilization of health care products - Liquid chemical sterilizing agents forsingle-use medical devices utilizing animal tissues and their derivatives - Requirements for haracterization, development, validation and routinecontrol of a sterilization process for medical device Status: Valid YY 0970: Historical versions
Basic dataStandard ID: YY 0970-2023 (YY0970-2023)Description (Translated English): Sterilization of health care products - Liquid chemical sterilizing agents forsingle-use medical devices utilizing animal tissues and their derivatives - Requirements for haracterization, development, validation and routinecontrol of a sterilization proce Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 34,337 Date of Issue: 2023-03-14 Date of Implementation: 2026-05-01 Older Standard (superseded by this standard): YY 0970-2013 Issuing agency(ies): State Drug Administration Summary: This standard specifies the characteristics of liquid chemical sterilants for the sterilization of single-use medical devices wholly or partly derived from animal materials, as well as the requirements for sterilization development, validation, process control and monitoring. This document applies to the risk control of bacterial and fungal contamination during the chemical sterilization of liquids. Risks associated with other microorganisms can be assessed using other methods. This document does not apply to: materials of human origin; confirmation of inactivation of viruses and transmissible spongiform encephalopathies (TSE); confirmation of inactivation or elimination of protozoa and parasites; treatments to reduce bioburden during production; sterilization The test and evaluation of the suitability of the process for the use of medical devices; the formulation of the residual levels of sterilants in medical devices. YY 0970-2023: Sterilization of health care products - Liquid chemical sterilizing agents forsingle-use medical devices utilizing animal tissues and their derivatives - Requirements for haracterization, development, validation and routinecontrol of a sterilization process for medical device---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. ICS11:080:01 CCSC47 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0970-2013 Healthcare Product Sterilization Single Use Animal Origin Liquid chemical sterilants for medical devices Medical devices Characterization, development, validation and routine control of sterilization processes requirements (ISO 14160:2020, MOD) 2023-03-14 release 2026-05-01 implementation Released by the State Drug Administration table of contentsPreface I Introduction III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General 4 5 Sterilant characteristics 5 6 Process and equipment characteristics 6 7 Product Definition 7 8 Process definition 7 9 confirm 8 10 General monitoring and control 11 11 Product Sterilization Release 12 12 Maintaining the effectiveness of the sterilization process 12 Appendix A (informative) The degree of consistency between YY/T 0567 and each part of ISO 13408 14 Appendix B (Informative) Application Guide 15 Appendix C (Normative) Determination of Kill Rate in Sterilization Process 24 Appendix D (informative) Microbial killing effect, process definition and microbial performance identification flow chart 27 Reference 28forewordThe entire technical content of this document is mandatory: 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 replaces YY 0970-2013 "Sterilization of single-use medical devices containing animal source materials Recognition and Routine Controls: Compared with YY 0970-2013, the main differences are as follows: --- Changed the name of the standard; --- Changed the scope of the standard; ---Added GB/T 16886:1, GB/T 16886:17, GB/T:19973:1, General Rules of Part Four of Pharmacopoeia of the People's Republic of China 1101 Sterility test method, YY/T 0567 (all parts) and other normative references (see Chapter 2), delete ISO 9001: 1994, ISO 9002:1994, ISO 11138-1:1994, ISO 11737-1:1995, ISO 13408-1:1998 and other normative references Use documents (see Chapter 2 of the:2013 edition); --- Changed terms and definitions [Added "maintenance time" (see 3:5), "inactivation curve" (see 3:6), "installation qualification" (see 3:8), "operating Identification" (see 3:11), "parametric release" (see 3:12), "product family" (see 3:14), "reference microorganism" (see 3:15), "re-qualification "Determined" (see 3:16), "Requirements" (see 3:17), "Sterile Barrier System" (see 3:19), "Sterilization Assurance Level" (see 3:21), "Substitute Product" (see 3:24), "sterility test" (see 3:25), "organization" (see 3:26), changed "batch" (see 3:1, 3:1 of the:2013 edition), "Bioburden" (see 3:2, 3:2 of the:2013 edition), "D value" (see 3:4, 3:5 of the:2013 edition), "contaminated carrier" (see 3:7, 3:8 of the:2013 edition), "liquid chemical sterilant" (see 3:9, 3:9 of the:2013 edition), "inactivation" (see 3:10,:2013 edition 3:7), "performance appraisal" (see 3:13, 3:11 of the:2013 edition), "confirmation" (see 3:27, 3:20 of the:2013 edition), deleted "test Operation" (see 3:4 of the:2013 edition), "action time" (see 3:6 of the:2013 edition), "medical device" (see 3:4 of the:2013 edition 3:10), "count before sterilization" (see 3:12 of the:2013 edition), "product suitability" (see 3:13 of the:2013 edition), "process development" (see 3:14 of the:2013 edition), "reconfirmation" (see 3:15 of the:2013 edition), "viable count" (see:2013 edition 3:21)]; --- Added "Sterilant Characteristics" (see Chapter 5), "Process and Equipment Characteristics" (see Chapter 6), "Product Definition" (see Chapter 7), "Process Definition" (see Chapter 8), "Maintaining the Sterilization Process Effectiveness" (see Chapter 12), "YY/T 0567 and ISO 13408 The degree of consistency between the various parts of the standard" (see Appendix A), "Determination of the kill rate of the sterilization process" (see Appendix C), "Microbial Killing effect, process definition and microbial performance identification flow chart" (see Appendix D) and other technical contents; ---Changed the chapter "General" (see Chapter 4, Chapter 4 of the:2013 edition); ---Changed the chapter "Confirmation" (see Chapter 9, Chapter 5 of the:2013 edition); ---Changed the chapter "General Monitoring and Control" (see Chapter 10, Chapter 6 of the:2013 edition); ---Changed the chapter "Product Sterilization Release" (see Chapter 11, Chapter 7 of the:2013 edition); --- Changed the "Application Guidelines" (see Appendix B, Appendix A of the:2013 edition): This document is modified to adopt ISO 14160:2020 "Liquid chemistry for the sterilization of single-use medical devices of animal origin for the sterilization of healthcare products": Requirements for the Characterization, Development, Validation and Routine Control of Sterilization Processes for Medical Devices": The technical differences between this document and ISO 14160:2020 and their reasons are as follows: --- Regarding the normative reference documents, this standard has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows: ● Added "Pharmacopoeia of the People's Republic of China" General Chapter 1101 Sterility Test Method as a normative reference document, 10:6 Involving sterility testing requirements; ● Replace ISO 10993-1 with GB/T 16886:1, which is equivalent to the international standard (see Chapter 7); ● Replace ISO 10993-17 with GB/T 16886:17, which is equivalent to the international standard (see Chapter 1, Chapter 7); ● Replaced ISO 11737-1 with GB/T:19973:1, which is equivalent to the international standard (see Chapter 7, Chapter 8, Chapter 9, Chapter Chapter 10, Appendix B); ● Replace ISO 13408 (all parts) with YY/T 0567 (all parts), the degree of consistency between the parts of the two standards See Appendix A: --- The definition of the term "medical device" has been deleted to avoid conflicts with the definition of "medical device" in my country's regulations: ---Changed the pollutant consideration requirements in 5:2:1, because if the pollutants affect the suitability of animal materials for the intended use, they should Listed as an important feature of liquid chemical sterilants, the requirements for liquid chemical sterilants need to clearly define pollutants, and according to This standard requires verification: ---Changed the evaluation material requirements in 5:4:1, because the physical or/and chemical properties and applicability of the selected evaluation materials need to be checked The evaluation is used to determine the applicability of liquid chemical sterilants, and the selected materials should be treated with liquid chemical sterilants: unanimous: ---Changed the requirements in 9:4:2:3:2 that the non-linear inactivation kinetics should be processed by statistical methods, because the inactivation curve is a microorganism For the prediction curve of the killing process, the logarithmic relationship between the number of microorganisms surviving and the exposure time is linear, which is not the only inactivation curve The existence of the line: For non-linear inactivation curves, in order to further control and predict the sterilization process to ensure the sterilization level, should use Statistical methods are used for processing: --- This document has made the following editorial changes: --- Deleted the preamble of the international standard; --- Deleted the expression in item a) of 9:4:4 according to the appropriate international standard (see references): Please note that some content of this document may involve patents, and the issuing organization of this document does not undertake the responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Standardization Technical Committee on Disinfection Technology and Equipment (SAC/TC200): The previous versions of the documents replaced by this document are as follows: ---YY 0970-2013:IntroductionA sterile medical device is a product free of viable microorganisms: This document specifies the requirements for validation and routine control of the sterilization process: When medical devices must be provided in a sterile form, all kinds of unintended microbial contamination should be minimized before they are sterilized: even medical devices The product is produced under standard manufacturing conditions that meet the requirements of the medical device quality management system (for example: YY/T 0287-2017): There may still be a small amount of microorganisms in the front of the bacteria: The purpose of sterilization is to inactivate microorganisms so that non-sterile products can be transformed into sterile products: The kinetics of the inactivation of pure-bred microorganisms by physical and/or chemical factors for sterilization of medical devices can generally be determined by the The exponential relationship between the number of substances and the degree of sterilization is well described: This means that regardless of the degree of sterilization, there must be microbial presence: probability of living: For a given treatment, the survival probability of microorganisms depends on the number of microorganisms, their resistance and the environment that exists: Therefore, it cannot be guaranteed that any one of a batch of sterilized medical devices is sterile, and the sterility of batch products is Defined as the probability of the presence of viable microorganisms in one of the medical devices: Other factors also require attention, including the microbial status (bioburden) of the raw materials used and/or their components and their subsequent storage: Storage, as well as the control of product production, assembly and packaging environment (see YY/T 0287-2017): YY/T 0287-2017 stipulates the requirements for the quality management system of medical device production: This quality management system standard recognizes that manufacturing The effectiveness of some processes cannot be fully verified by subsequent product inspections and tests, and sterilization is such a special process: Therefore, to deal with Validation of the sterilization process, routine monitoring of sterilization process performance and maintenance of equipment: The use of animal tissues and their derivatives as components of certain medical devices may cause medical devices to have better performance: The range and amount of materials of animal origin in medical devices varies, and these materials can be a major component of the device, It can also be the coating or impregnating agent of the product, or the auxiliary material used in the production process: If applicable to this document, it is required to provide liquid chemical sterilization process suitable for sterilization of single-use medical devices of animal origin: Effect: The most commonly used sterilization methods for medical devices are moist heat, dry heat, irradiation and ethylene oxide sterilization: Some medical devices of animal origin may It is suitable for these conventional sterilization methods (for example, sheep intestinal sutures have been sterilized by irradiation historically), while other medical devices, such as biological heart valves Membranes or tissue patches are not suitable for traditional sterilization processes: It is recognized that other sterilization methods must be used in these special cases Mode: In order for medical devices to maintain the required physical properties of the tissue after sterilization, liquid chemical sterilization is more commonly used than other sterilization methods: Liquid chemical sterilization of medical devices of animal origin, in whole or in part, represents a special case in which effective sterilization processes are established: with other As with sterilization methods, liquid chemical sterilization processes need to be proven and documented to be effective before they can be used routinely: Chemical sterilization of liquids requires the determination of the type of microorganisms involved in the bioburden and their resistance to the sterilization process in order to identify appropriate reference microorganisms, The microorganism can be a recognized biological indicator or a microorganism isolated from a bioburden: According to the requirements of this document, ensure that Microbial kill during chemical liquid sterilization is reliable and reproducible, so that there is good reason to predict The probability of living microorganisms is very low: Sterility Assurance Levels (SALs) are determined by the main regulatory authority and vary by region or country (e:g: Such as: EN556-1 and ANSI/AAMIST67): Exposure to a properly validated and accurately controlled sterilization process is not the only factor in ensuring that a product is sterile and fit for intended use: because In addition, the following aspects need to be considered: a) animal tissue sources and acquisition conditions; b) the microbiological status of the raw materials and/or components used; c) routine controls for cleaning and sanitizing procedures for products; d) Environmental control during product manufacturing, assembly and packaging; e) control of equipment and processes; f) control of personnel and their hygiene; g) the manner in which the product is packaged and the packaging material; and h) Storage conditions of the product: Healthcare Product Sterilization Single Use Animal Origin Liquid chemical sterilants for medical devices Medical devices Characterization, development, validation and routine control of sterilization processes requirements1 ScopeThis document specifies the requirements for liquid chemical sterilants for the sterilization of single-use medical devices wholly or partly derived from animal materials: characteristics, and requirements for sterilization development, validation, process control and monitoring: This document is applicable to the risk control of bacterial and fungal contamination in the liquid chemical sterilization process, the risks associated with other microorganisms can be used Other methods for evaluation (see Note 1): This document does not apply to: ---Materials of human origin; ---Confirmation of virus and transmissible spongiform encephalopathy (TSE) inactivation (see Note 2 and Note 3); --- Confirmation of inactivation or elimination of protozoa and parasites; --- Treatment process to reduce bioburden during production (see Note 4); --- Test and evaluation of the suitability of the sterilization process for the use of medical devices (see Note 5); ---Development of sterilant residue levels in medical devices (see Note 6): Note 1: According to the description in YY/T 0771:1, it is very important to prioritize the application of risk management principles for medical devices of animal origin: ISO 18362 provides the basis for Microbial risk control in the production process of cell-based healthcare products: NOTE 2: Liquid chemical sterilants are commonly used to sterilize animal tissues in medical devices and may be effective against transmissible spongiform encephalopathy (TSE) such as bovine spongiform encephalopathy (BSE) or inactivation of the causative agent of scrapie did not work: It is therefore not appropriate to use the methods of this document to confirm the inactivation of this class of infectious agents: and See YY/T 0771:2 for risk control related to the source, collection and disposal of animal materials: Note 3: See YY/T 0771:3 for confirmation of inactivation and/or elimination of viruses and TSE pathogenic factors: Note 4: The production process of medical devices of animal origin often includes exposure to chemical agents, which can significantly reduce the bioburden of medical devices: in the production process Afterwards, the medical device is exposed to a specific sterilization process: Note 5 to entry: Such tests are a key component in the design and development of medical devices: Note 6: GB/T 16886:17 specifies the method for establishing acceptable limits of sterilant residues:2 Normative referencesThe contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process (GB/T 16886:1- 2011, ISO 10993-1:2009, IDT) GB/T 16886:17 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (GB/T 16886:17- 2005, ISO 10993-17:2002, IDT) GB/T:19973:1 Microbiological methods for sterilization of medical devices Part 1: Determination of the total number of microorganisms on the product (GB/T:19973:1-2015, ISO 11737-1:2006, IDT) ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0970-2023_English be delivered?Answer: Upon your order, we will start to translate YY 0970-2023_English as soon as possible, and keep you informed of the progress. 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