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Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 19974-2018: Sterilization of health care products -- General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices Status: Valid GB/T 19974: Historical versions
Basic dataStandard ID: GB/T 19974-2018 (GB/T19974-2018)Description (Translated English): Sterilization of health care products -- General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C47 Classification of International Standard: 11.080.01 Word Count Estimation: 34,397 Date of Issue: 2018-05-14 Date of Implementation: 2019-06-01 Older Standard (superseded by this standard): GB/T 19974-2005 Quoted Standard: GB 18281.1-2015; YY/T 0287-2003; ISO 10012; ISO 10993-1; ISO 10993-17; ISO 11140-1; ISO 11737-1; ISO 11737-2; IEC 61010-2-040 Adopted Standard: ISO 14937-2009, IDT Regulation (derived from): National Standards Announcement No. 6 of 2018 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration Summary: This standard specifies the characteristics of sterilization factors and general requirements for the development, validation, and routine control of sterilization procedures for medical devices. This standard applies to the sterilization of microorganisms by physical or chemical methods. This standard will be used by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for the sterilization of medical devices. This standard specifies the elements of the quality management system that should be used to ensure proper characteristics of the sterilization factors, development, validation, routine monitoring, and sterilization process controls. This standard does not apply to the process of simply relying on physical methods to remove bacteria (such as filtration). This standard does not specify the specific test steps for microbial inactivation evaluation. This standard does not stipulate the characteristics of the bactericidal factor and the development, confirmation and routine control requirements of the inactivation process of the pathogen of spongiform encephalopathy. For example: GB/T 19974-2018: Sterilization of health care products -- General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices---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. Sterilization of health care products. General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices ICS 11.080.01 C47 National Standards of People's Republic of China Replace GB/T 19974-2005 Characteristics of sterilization and sterilization factors for healthcare products and Development, validation and validation of medical device sterilization processes General requirements for routine control (ISO 14937.2009, IDT) 2018-05-14 released.2019-06-01 implementation State market supervision and administration China National Standardization Administration issued ContentForeword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 Quality Management System Elements 6 5 Sterilization factor characteristics 6 6 Process and equipment characteristics 7 7 Product Definition 8 8 Process Definition 8 9 Confirmation 9 10 General Monitoring and Control 10 11 Product release after sterilization 11 12 Maintain process effectiveness 11 Appendix A (Normative Appendix) Indicators for Verifying Microbial Killing Effects Microbiological Selection Factors 12 Appendix B (Normative) Method 1 Process definition based on the number of microbial inactivation in natural conditions 14 Appendix C (Normative) Method 2 Process definition based on reference microbial inactivation and bioburden knowledge 15 Appendix D (Normative) Method 3 Definition of Conservative Process Based on Reference Microbial Inactivation 16 Appendix E (informative) The application guide for this standard 17 Reference 28ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces GB/T 19974-2005 "The characteristics of sterilization and sterilization factors for medical care products and the opening of medical device sterilization process General requirements for hair, confirmation and general control. The main technical differences between this standard and GB/T 19974-2005 are as follows. --- Added the definition of "Process Challenge Device (PCD)" (see 3.18). This standard uses the translation method equivalent to ISO 14937.2009 "the characteristics of medical products sterilization and sterilization factors and medical devices General requirements for the development, validation and routine control of bacterial processes. The documents of our country that have a consistent correspondence with the international documents referenced in this standard are as follows. Safety of electrical equipment for measurement, control and laboratory use - Part 4. Special requirements for sterilizers and washer-disinfectors (idtIEC 61010-2-041.1995) --- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993-1.2009, IDT) --- GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (ISO 10993-17.2002, IDT) --- GB 18282.1-2015 Health care products - Sterilization of chemical indicators - Part 1. General (ISO 11140-1.2005, IDT) ---GB/T 19022-2003 Measurement management system measurement process and measurement equipment requirements (ISO 10012.2003, IDT) --- GB/T 19973.1-2015 Microwaveological methods for the sterilization of medical devices - Part 1 Ding (ISO 11737-1.2006, IDT) --- GB/T 19973.2-2018 Sterilization of medical devices - Microbiological methods - Part 2 Aseptic testing for validation and maintenance (ISO 11737-2.2009, IDT) Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., Nanjing Minimally Invasive Medicine Science and Technology Co., Ltd. The main drafters of this standard. Fan Yawen, Wang Hongmin, Xu Xinggang, Huang Hongxin. The previous versions of the standards replaced by this standard are. ---GB/T 19974-2005.IntroductionA sterile medical device is a device that has no living microorganisms. The standard specifies the requirements for confirmation and routine control of the sterilization process. When the device is to be provided in a sterile form, all undesired microbial contamination should be minimized prior to sterilization. Even medical devices The product is produced under standard manufacturing conditions that meet the requirements of the quality management system (eg YY/T 0287-2003) and will still be carried before sterilization. There are a small number of microorganisms, and such devices are non-sterile devices. The purpose of sterilization is to inactivate microorganisms and convert non-sterile instruments into sterile instrument. The kinetics of inactivation of pure microbial culture using physical factors and/or chemical factors for sterilization of medical devices can generally be carried out using residual microorganisms. The exponential relationship between quantity and degree of sterilization is well described. This means that microbial survival is inevitable regardless of the degree of sterilization. The probability. For established treatment methods, the survival probability of residual microorganisms depends on the number of microorganisms, resistance and microorganisms during treatment. The environment in which it exists. Therefore, any product in the batch product that has undergone the sterilization process cannot be guaranteed to be sterile and batch processed through the sterilization process. Sterility of a product is defined as the probability of the presence of living microorganisms in the medical device. If satisfied, the requirements described in this standard will provide a moist heat that is expected to be used in medical devices with appropriate microbicidal activity. Sterilization process. Moreover, compliance with this standard ensures that sterilization is reliable and repeatable, so that there is reason to believe that microbes survive after sterilization. The probability is relatively low. The probability of microbial survival to achieve sterility requirements is dictated by the standard. (eg EN556-1 and ANSI/AAMI) ST67). General requirements for quality management systems such as design and development, production, installation and service are listed in ISO 9001, Medical Device Production Quality Management See YY/T 0287 for special requirements. These quality management system standards believe that some processes in manufacturing cannot be fully validated. Verification of the continued product inspection and testing, sterilization is such a process. Therefore, before the implementation of the sterilization process, it should be confirmed that the sterilization process The effectiveness of the inspection should be routinely monitored and equipment should be maintained. Exposure to a properly identified and accurately controlled sterilization process is not the only factor that ensures the product is sterile and suitable for the intended use. Therefore, we should also pay attention to the following aspects. a) the microbiological status of incoming raw materials and/or components; b) any confirmation and routine control of the cleaning and disinfection procedures for the product; c) control of the manufacturing, assembly and packaging environment of the product; d) control of equipment and processes; e) control of personnel and their health; f) the packaging method and packaging materials of the product; g) Storage conditions of the product. The type of contamination of the sterilized product affects the effectiveness of the sterilization process. It is recommended to use the medical institution and follow the manufacturer's instructions. The book requirements (see ISO 17664) are reproducible medical devices as special cases. Despite cleaning, these products may still be widely available Contaminated by microorganisms and residual organic and/or inorganic pollution. Therefore, special attention should be paid to the cleaning and disinfection process during repeated processing of the device. Confirmation and control. The requirements that this standard claims to meet are the normative part of this standard. The guidelines in Appendix E are not intended to be normative requirements, nor are they The reviewer's review form is provided. The interpretations and methods given in the guide should be considered as necessary means of meeting the requirements of the standard. If it can also be satisfied The requirements of this standard, methods not specified in the guide can also be used. The development, validation, and routine control of the sterilization process involves several inconsistent but related activities such as calibration, maintenance, product definition, and Process definition, installation qualification, operational qualification, and performance qualification. Although the activities specified in this standard are grouped and arranged in a specific order, this is not These activities are required to be in the order in which they are presented in this standard. The required activities do not need to be in order because the development and validation in the process can Can be repeated. The responsibilities for activities that implement the requirements of this standard vary from case to case. The requirements of this standard stipulate the duties of all parties Responsibility (see 4.2), but does not stipulate who the specific responsibilities belong to. Appendix E provides guidance on the assignment of responsibilities. This standard has three distinct uses. --- Manufacturers of medical devices that will sterilize their products without specific standards; --- for manufacturers and users of health care institutions without specific standards; --- As a framework for the development and revision of specific sterilization process standards. Characteristics of sterilization and sterilization factors for healthcare products and Development, validation and validation of medical device sterilization processes General requirements for routine control1 Scope1.1 Scope of application 1.1.1 This standard specifies the characteristics of the sterilization factor and the general requirements for the development, validation and routine control of the sterilization process of medical devices. Note. Although the scope of this standard is limited to medical devices, the requirements specified in this standard can also be applied to other health care products. 1.1.2 This standard applies to the sterilization process of inactivating microorganisms by physical or chemical means. 1.1.3 This standard will be used by process developers, sterilization equipment manufacturers, manufacturers of medical devices to be sterilized, and medical devices. The bacteria are responsible for the use of the organization. 1.1.4 This standard specifies the quality management for the sterilization factors, development, validation, routine monitoring and sterilization process control to ensure proper characteristics. System elements. Note. This standard does not require a complete quality management system. The necessary elements are referenced in the appropriate places in the text (see Chapter 4 for details). Need to lead Attention is drawn to the quality management system standards that control all stages of production or processing of medical devices (see YY/T 0287). Concerning the supply of medical devices National and/or regional regulations may require that a complete quality management system be implemented and that the evaluation of the system be implemented by a third party. 1.2 Not applicable 1.2.1 This standard does not apply to processes that rely solely on physical methods to remove bacteria (eg, filtration). 1.2.2 This standard does not specify the specific test procedures for microbial inactivation evaluation. 1.2.3 This standard does not specify the characteristics of sterilization factors and the development, validation and routine control requirements for the inactivation of spongiform encephalopathy pathogens, such as. Scrapie, bovine spongiform encephalopathy, Creutzfeldt-Jakob disease. In particular, some countries have recommended special treatment of potentially contaminated materials subject to such factors. Methods. Note. See ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.4 This standard does not replace or modify the standards of published special sterilization processes.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB 18281.1-2015 Sterilization of biological indicators for health care products - Part 1. General (ISO 11138-1.2006, IDT) YY/T 0287-2003 Medical device quality management system for regulatory requirements (ISO 13485.2003, IDT) ISO 10012 Measurement Management System Measurement Methods and Measurement Equipment Requirements (Measurementmanagementsystems- Requirementsformeasurementprocessesandmeasuringequipment) ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua- tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess) ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (Biological evaluationofmedicaldevices-Part 17.Establishmentofalowablelimitsforleachablesubstances) ISO 11140-1 Sterilization of health care products - Part 1 . General rules (Sterilization of health care) products-Chemicalindicators-Part 1.Generalrequirements) ISO 11737-1 Methods of sterilizing microbiology of medical devices - Part 1 (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 1.Determinationofapopulationof Microorganisms products) ISO 11737-2 - Microbiological methods for the sterilization of medical devices - Part 2. Definitions, s Sterility test (Sterilization of medical devices-Microbiological methods-Part 2. Testsofsterilityper- Formedinthedefinition,validationandmaintenanceofasterilizationprocess) Safety of electrical equipment for measurement, control and laboratory use - Part 4. Special requirements for sterilizers and washer-disinfectors (Safetyrequirementsforelectricalequipmentformeasurement,con- trolandlaboratoryuse-Part 2-040.Particularrequirementsforsterilizersandwasher-disinfectors Usedtotreatmedicalmaterials)3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Bioburden The total number of viable microorganisms on the surface or inside of the product and/or sterile barrier system. [See GB/T 19971-2015, definition 2.2] 3.2 Biological indicator biologicalindicator Specific resistance to the prescribed sterilization process, including a test system for live microorganisms. [See GB/T 19971-2015, definition 2.3] 3.3 Change control changecontrol Appropriate assessment and decision on the proposed changes to the product or program. [See GB/T 19971-2015, definition 2.5] 3.4 Chemical indicator chemicalindicator Abiotic indicator non-biologicalindicator A test that exhibits one or more predetermined process variable changes based on chemical or physical changes that result from exposure to a sterilization process system. [See GB/T 19971-2015, definition 2.6] 3.5 Corrective action correctiveaction Measures taken to eliminate the cause of the identified nonconformities or other undesired conditions. Note 1. There may be several reasons for a failure. Note 2. Corrective action is taken to prevent recurrence, and precautionary measures (3.17) are taken to prevent it from happening. Note 3. Correction (3.6) and corrective action are different. [See GB/T 19000-2008, Definition 3.6.5] 3.6 Correct corrective Measures taken to eliminate identified nonconformities. Note. Correction can be implemented in conjunction with corrective action (3.5). [See GB/T 19000-2008, Definition 3.6.6] 3.7 Development Develop a detailed activity. [See GB/T 19971-2015, definition 2.13] 3.8 Establish establish Determined by theoretical evaluation and confirmed by experiments. [See GB/T 19971-2015, definition 2.17] 3.9 Fault fault One or more process parameters are outside the specified tolerance range. [See GB/T 19971-2015, definition 2.19] 3.10 Healthcare products healthcareproduct(s) Medical devices (including in vitro diagnostic medical devices) or medical products (including biopharmaceutical products). [See GB/T 19971-2015, definition 2.20] 3.11 Installation identification instalationqualification; IQ Proof that the equipment has been provided and installed as required by the specification to obtain and form documented evidence. [See GB/T 19971-2015, definition 2.22] 3.12 Material Safety Data Sheet materialsafetydatasheet; MSDS A document detailing the material properties and their potential hazards to humans and the environment, and the necessary precautions for safe use and disposal of articles. [See GB/T 19971-2015, definition 2.23] 3.13 Medical device medicaldevice The intended use of the manufacturer is for one or more of the following specific purposes, for humans, whether used alone or in combination, Equipment, appliances, equipment, utensils, implants, in vitro reagents or calibrators, software, materials or other similar or related items. These purposes are. --- Diagnosis, prevention, monitoring, treatment or relief of the disease; ---Diagnosis, monitoring, treatment, mitigation or compensation of injuries; --- research, substitution, regulation or support of anatomical or physiological processes; ---Support or sustain life; ---Pregnant control; --- Disinfection of medical devices; --- Provide medical information by inspecting samples taken from the human body in vitro. The main design effects on the body surface or in the body are not obtained by pharmacological, immunological or metabolic means, but may have these The means to participate and play a certain auxiliary role. [See YY/T 0287-2003, definition 3.7] Note. This definition in YY/T 0287-2003 was developed by the Global Coordination Working Group (GHTF2002). 3.14 Operational authentication operationalqualification; OQ A process of obtaining and documenting evidence that an installed device is capable of operating within predetermined limits when used in accordance with operational procedures. [See GB/T 19971-2015, definition 2.27] 3.15 Parameter release parametricrelease The product is declared sterile according to records that demonstrate that the process parameters are within the specified tolerances. [See GB/T 19971-2015, definition 2.29] 3.16 Performance qualification performancequalification; PQ Prove that equipment that has been installed and operated in accordance with the operating procedures, can produce prod......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 19974-2018_English be delivered?Answer: Upon your order, we will start to translate GB/T 19974-2018_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 19974-2018_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 19974-2018_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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