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GB 18278.1-2015: Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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GB 18279   GB/T 18279.2   GB 18280.1   GB/T 18282.1   

GB 18278.1-2015: Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Sterilization of health care products - Moist heat - Part 1.Requirements for 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 Replacing GB 18278-2000, GB/T 20367-2006 Sterilization of health care products heat Part 1.Medical device sterilization process development, Validation and routine control Part 1.Requirementsforthedevelopment, validationandroutinecontrol (ISO 17665-1.2006, IDT) Issued on. 2017-01-01 2015-12-10 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Preface Ⅰ Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Quality Management System Elements 8 5 sterilization factor characterization 9 6 features described processes and equipment 9 7 Products OK 12 8 process determines 12 9 Confirm 13 10 Routine monitoring and control 15 11 sterilized product release 16 12 to maintain the effectiveness of the process 16 Appendix A (informative) Guide 18 Annex B (informative) based on the state of the natural microflora inactivation process determines (based on bioburden method) 22 Annex C (informative) knowledge-based process of inactivation of the reference microorganisms and biological products to be sterilized load is determined (based on Bioburden combined biological indicator method) 23 Annex D (normative) based on the reference microorganism inactivation traditional process determines (overkill approach) 24 Annex E (informative) run cycle 26 References 30

Foreword

All technical content in this Part of GB 18278 is mandatory. GB 18278 "Sterilization of health care products heat" is divided into the following two parts. --- Part 1.Development of medical equipment sterilization process, validation and routine control requirements; --- Part 2.Application guide. This is part of the GB Part 118 278. This section drafted in accordance with GB/T 1.1-2009 given rules. This section and GB/T 18278.2 together instead of GB 18278-2000 "Sterilization of health care products for validation and routine control requirements Confirmed that health care products Sterilization of health care institutions moist heat sterilization industrial heat sterilization "and GB/T 20367-2006" and conventional control Claim". Compared with GB 18278-2000 and GB/T 20367-2006 main differences are as follows. --- For industrial moist heat sterilization and heat sterilization two aspects of health care organizations; --- Increasing the sterilization factor features, product definition, process definition, installation qualification, operational qualification, to maintain the effectiveness of the sterilization process technology content. This part identical with ISO 17665-1.2006 "developed heat sterilization of health care products for medical device sterilization process, indeed Recognize and routine control. " Consistency correspondence between this part of international documents and normative references of our files are as follows. --- GB 18281.1-2015 Sterilization of health care products - Biological indicators - Part 1.General (ISO 11138-1.2006, IDT); --- GB 18281.3-2015 Sterilization of health care products - Biological indicators - Part 3.Biological indicators for moist heat sterilization (ISO 11138-3.2006, IDT); --- GB 18282.1-2015 Sterilization of health care products - Chemical indicators - Part 1.General (ISO 11140-1.2005, IDT); --- GB 18282.3-2009 Sterilization of health care products - Chemical indicators - Part 3.Class BD for steam penetration test The Class 2 indicator systems (ISO 11140-3.2007, IDT); --- GB 18282.4-2009 Sterilization of health care products - Chemical indicators - Part 4.BD used to replace steam penetration test Examination II indicators (ISO 11140-4.2007, IDT); --- GB 18282.5-2015 Sterilization of health care products chemical indicators - Part 5.Class of air exclusion measure for BD Examination II indicators (ISO 11140-5.2007, IDT); --- GB/T 19022-2003 Measurement management systems for measurement processes and measuring equipment (ISO 10012-2003, IDT); --- GB/T 19633.1-2015 terminally sterilized medical device packaging - Part 1.materials, sterile barrier systems and packaging systems Requirements (ISO 11607-1.2006, IDT); --- GB/T 19633.2-2015 terminally sterilized medical device packaging - Part 2.Confirm forming, sealing and assembly processes to Demand (ISO 11607-2.2006, IDT); Part 1 sterilization Microbiological Methods --- GB/T 19973.1-2015 medical devices. the total number of microorganisms on the product test Set (ISO 11737-1.2006, IDT); --- GB /sterilization Methodology Part 2 microbial T 19973.2-2005 Medical Devices. Confirm sterile test sterilization procedures Test (ISO 11737-2.1998, IDT); --- YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT); --- Processing YY/T 0802-2010 sterilization of medical equipment manufacturers to provide the information may be repeated sterilization of medical devices (ISO 17664.2004, IDT). This part made the following editorial changes. --- According to GB/T 1.1 requirements of a number of editorial changes; --- Deleted international standards foreword; --- Introduction of international standards and references appear to replace the corresponding country standards. Please note that some of the content of this document may involve patents. Issuer of this document does not assume responsibility for the identification of these patents. This part is proposed by the China Food and Drug Administration. This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This section drafted by. Shandong Xinhua Medical Instrument Co., Ltd., Michael Di Jincheng Medical Devices Co., Ltd., the State Food and Drug Goods Administration of Guangzhou Medical Device Quality Supervision and Inspection Center, Belimed Medical Equipment (Shanghai) Co., Ltd. The main drafters of this section. Wang Hongmin, Lv Liansheng, Xu Honglei,.Image, Xuwei Xiong, Huang Xiulian. This part of the standard replaces the previous editions are. --- GB 18278-2000; --- GB/T 20367-2006.

introduction

Sterile medical devices is a non-living micro-organisms products. International Standard specifies confirm the sterilization process and routine control of when Medical devices must be provided in sterile form, it should be sterilized before its various unintended microbiological contamination to a minimum. Even medical devices Mechanical products to meet the quality management system (for example. ISO 13485) requirements under standard production conditions produced before sterilization still with A small amount of micro-organisms, such products shall be guilty of non-sterile products. Purpose of sterilization is to inactivate microorganisms, non-sterile products into sterile product. Physical factors and/sterilization of medical devices using kinetic or chemical factors on pure cultures of microorganisms surviving microorganisms can be inactivated general The number was exponential relationship between the degree of sterilization and be a good description. This means that regardless of the degree of sterilization, there must exist a microorganism Live probability. For the treatment has been given, the remaining microorganism survival probability depends on the number of microbes, microbial resistance and processing It was occurring environment. Therefore, sterilized products batch processing in any one of the products can not be guaranteed to be sterile, sterilized batch processing Sterile product is defined as the amount of living micro-organisms present in the probability of the medical device. If satisfied, the requirements of this standard will provide a description of the medical device intended to be used with appropriate antimicrobial activity of heat to kill off Bacteria process. Moreover, to ensure compliance with this standard sterilization is reliable and repeatable, thus reason to believe that the probability of surviving microorganisms after sterilization Rate relatively low. Sterility requirements for microbial survival probability by the regulatory requirements may vary by country (such as YY/T 0615.1). General requirements for design and development, production, installation and services such as quality management system, see GB/T 19001, medical equipment production quality Particular requirements for management systems see ISO 13485.These quality management system standard that some of the effectiveness of the process of manufacture can not be completely Through subsequent product inspection and testing to verify sterilization belongs to this process. Therefore, before the implementation of the sterilization process should be recognized, to destroy The effectiveness of the process of bacteria should be regular monitoring should be carried out equipment maintenance. Exposure to the sterilization process and to give due recognition to accurately control is not the only factor to ensure product sterility and appropriate for the intended use. Therefore, we should note the following aspects. a) the microbiological status of incoming raw materials and/or components; b) conventional control and confirm any products for cleaning and disinfection procedures; c) product manufacturing, assembly and packaging control environment; d) control equipment and processes; e) control of personnel and their hygiene; f) packaging products and packaging materials; g) the product storage conditions. Impact of pollution with different types of sterile products, the effectiveness of the sterilization process. It is preferable to medical institutions and used in accordance with the manufacturer's instructions Book requirements (see ISO 17664) sterilized again every product as special cases. Although cleaned, these products may still be extensive The microbial contamination and residual organic and/or inorganic pollution. Therefore, we must pay special attention to repeat the process equipment cleaning and disinfection through Process validation and control. This section describes the requirements of GB 18278 and ensures moist heat sterilization process related behavior correctly. These actions have been shaped The program of work has been documented description of the process used to prove to the variable within predetermined limits run, the heat sterilization process will continue output Sterile products. This section is normative requirements should be consistent with this. Informative appendix guide, not a regulatory requirement, not as an auditor The review form is provided. Interpretation and methodological guidance given should be regarded as an appropriate means to comply with the requirements of this section. If it can meet this Part Requirements points, the method does not give guidelines can also be used. Sterilization process development, validation and routine control contains a number of incoherent but related activities, such as. calibration, maintenance, product definition, too Process definition, installation qualification, operational qualification and performance qualification. Although this part of the provisions of the act are grouped and arranged in a particular order, it does not Requirements of these acts must be arranged in a standard order. Behavior is not necessarily required to be sequential, because in the process of development and validation You may need to repeatedly implemented. Implement different behavior may involve a number of separate individuals and/or organizations, each of them are likely to bear a Implement one or more actions. This section does not specify particular individual or organization of certain acts. Sterilization of health care products heat Part 1.Medical device sterilization process development, Validation and routine control 1 Scope GB 18278 of the provisions of this part of the development of medical devices moist heat sterilization, validation and routine control. Note. Although the scope of this section is limited to medical devices, but require it to provide provisions and guidelines applicable to other health-related products. This section contains the following heat sterilization process, but not limited to. a) saturated steam - Gravity exhaust system; b) saturated steam - powered exhaust system; c) air-vapor gas mixture; d) water spray; e) water immersion. Note. See Appendix E. This section does not provide for the development of spongiform encephalopathy (disease such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease) pathogen inactivation process, recognition and often Regulatory control. For dealing with potential contamination by these pathogens in the material, some countries have developed special specifications. Note. See YY/T 0771.1, YY/T 0771.2, ISO 22442-3. This section does not apply to moist heat sterilization and other agents (such as. formaldehyde) sterilization sterilization process as a combination of factors. This section does not indicate specific requirements detailed in "sterile" medical instruments. Note. It should be noted that different countries and regions for the labeling of medical devices "sterile" have different requirements, for example, YY/T 0615.1 or ANSI/AAMIST67. This section does not provide for control of all stages of production of medical devices quality management system. Note. This section is not required for the manufacture of a complete quality management system requirements, it is only the minimum requirements for the control of the sterilization process required for quality management The basic elements of the system, these elements normative references in the text to the appropriate location (see especially Chapter 4) as. We should focus on controlling medical equipment production All stages (including the sterilization process including) quality management systems (see ISO 13485). Some countries may require medical devices By the implementation of a complete quality management system, and evaluated by third parties. This section does not specify the moist heat sterilization facility design and operation of related occupational safety requirements. Note. The requirements for the safe operation of the provisions of GB 4793.4.Moreover, some countries also have safety regulations. 2 Normative references The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1.General (Sterilizationofhealthcareprod- ucts-Biologicalindicators-GeneralRequirements) ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3.Biological indicators for moist heat sterilization (Sterilization ofhealthcareproducts-Biologicalindicators-Biologicalindicatorsformoistheatsterilizationproces- ses) ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1.General (Sterilizationofhealthcare products-Chemicalindicators-Part 1.Generalrequirements) Class 2 indicators for steam penetration test BD. ISO 11140-3 Sterilization of health care products - Chemical indicators - Part 3 Object system (Sterilizationofhealthcareproducts-Chemicalindicators-Part 3.Class2indicatorsystems foruseintheBowieandDick-typesteampenetrationtest) ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4.BD II used to replace steam penetration test finger Was shown (Sterilizationofhealthcareproducts-Chemicalindicators-Part 4.Class2indicatorsasanalter- nativetotheBowieandDick-typetestfordetectionofsteampenetration) ISO 11140-5 Sterilization of health care products chemical indicators - Part 5.Class II for BD air exclusion means test It was shown (Sterilizationofhealthcareproducts-Chemicalindicators-Part 5.Class2indicatorsforBowie andDick-typeairremovaltests) ISO 10012 Measurement management systems for measurement processes and measuring equipment (Measurementmanagementsystems- Requirementsformeasurementprocessesandmeasuringequipment) ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1.materials, sterile barrier systems and packaging systems requirements (Packa- gingforterminalysterilizedmedicaldevices-Part 1.Requirementsformaterials, sterilebarriersys- temsandpackagingsystems) ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2.forming, sealing and assembly processes requires confirmation of (Packagingforterminalysterilizedmedicaldevices-Part 2.Validationrequirementsforforming, sealingandassemblyprocesses) Sterilization Microbiological methods - Part 1 ISO 11737-1 medical devices. Determination of the total number of microorganisms on the product (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 1.Determinationofapopulationof microorganismsonproducts) Learn sterilization methods - Part 2 microorganisms ISO 11737-2 medical devices. sterility test confirmed the sterilization process (Sterilizationofmedicaldevices-Microbiologicalmethods-Part 2.Testsofsterilityperformedinthe validationofasterilizationprocess) ISO 13485.2003 Medical Device Quality Management System Requirements for regulatory purposes (Medicaldevices-Qualityman- agementsystems-Requirementsforregulatorypurposes) Sterilization process ISO 17664 medical device manufacturer providing reusable information (Sterilizationof sterilized medical devices medicaldevices-Informationtobeprovidedbythemanufacturerfortheprocessingofresterilizable medicaldevices) 3 Terms and Definitions The following terms and definitions apply to this document. 3.1 Air Detector airdetector Means for detecting whether or not the presence of non-condensable gases in the steam and condensate, or sterilization chamber. 3.2 Automatic controller automaticcontroler According to a predetermined program operating parameters, control sterilizer in order to run the program at all stages of the device required. 3.3 Bioburden bioburden The total number of products and/or sterile barrier system surfaces and/or internal viable microorganisms. [GB/T 19971-2015, Definition 2.2] 3.4 Biological indicators biologicalindicator Provisions sterilization process has a specific resistance, the test system containing viable microorganisms. [GB/T 19971-2015, the definition 2.3] 3.5 Calibration calibration Under specified conditions, to determine the magnitude of measuring instruments or measuring systems indicated, or the amount of material measure or reference material represents Value, and the corresponding reproduced by the standard set of operations between values. Its purpose is determined by comparison with a standard measuring device Indication. [VIM.1993, definitions 6.11] 3.6 Chemical indicators (non-biological indicators) chemicalindicator (non-biologicalindicator) Depending on the chemical or physical changes after exposure to a particular process, a reflection of changes in process variables or more predetermined test systems. [GB/T 19971-2015, the definition 2.6] 3.7 Sealed packaging products containedproduct At any stage of the sterilization process, without direct contact with the sterilizer product environment. Note. The internal environment of the sterilizer only for heating and cooling purposes, and not to obtain sterilization effect, for example, sealed bottle of solution. 3.8 Correct correction Measures taken to eliminate substandard have been found. Note 1.The correction can be made in conjunction with the implementation of corrective action together. Note 2.The example rework or downgrading as corrected. [GB/T 19000-2008, the definition 3.6.6] 3.9 Corrective measures correctiveaction Measures to eliminate substandard or other undesirable situation discovered the reason taken. Note 1.a failure can have several causes. NOTE 2.Corrective action is taken to prevent recurrence whereas preventive action is taken to prevent occurrence. Note 3.The correction and corrective action are different. [GB/T 19000-2008, the definition 3.6.5] 3.10 D value Dvalue D10 value D10value Under specified conditions, the inactivation of 90% of the test organisms or the time required dosage. NOTE. For this section is, D value refers to the sterilization process test microorganisms by 90%. [GB/T 19971-2015, the definition 2.11] 3.11 Development development Elaboration of a technical norms. [GB/T 19971-2015, the definition 2.13] 3.12 Environmental Control environmentalcontrol Application engineering and/or system procedures, specific environment maintained within the specified limits. Note. including air filters, liquid filters, surface disinfection, protective clothing, and management procedures. [GB/T 19971-2015, the definition 2.16] 3.13 Equilibration time equilibrationtime Measured from the reference point to achieve sterilization temperature, all point to the time of sterilization loads have reached the sterilizing temperature desired. 3.14 Setting establish Through theoretical determination, and after trials. [GB/T 19971-2015, the definition 2.17] 3.15 Exposure time exposuretime Time process parameters is maintained within a predetermined tolerance range. [GB/T 19971-2015, the definition 2.18] 3.16 Failure fault One or more process parameters exceed a predetermined tolerance range. [GB/T 19971-2015, the definition 2.19] 3.17 F0 value F0value Z value corresponds to the reference microorganisms at 10 ℃, 121.1 ℃ under the sterilization process for sterilization of time, in minutes (min). 3.18 Health care products healthcareproduct (s) Medical devices (including in vitro diagnostic medical devices) or pharmaceutical products (including biopharmaceuticals). [GB/T 19971-2015, the definition 2.20] 3.19 Duration holdingtime Sterilization chamber measuring point and reference point for all load sterilization temperature holding time in the continuous sterilization temperature range. 3.20 Installation identification instalationqualification; IQ Proof equipment according to specifications provided and installed, and documented process. [GB/T 19971-2015, the definition 2.22] 3.21 Load configuration loadconfiguration Provisions in article combination sterilizing chamber, including the sterilization chamber fixing member, and the number of items to be sterilized, type, distribution and direction. 3.22 Maintenance maintenance For an article is maintained at or restored to its state with the desired function of a combination of all technical and related management behavior. 3.23 Medical Devices medicaldevice Manufacturer's intended use for one or more specific purposes for human instrument, whether used alone or in combination, provided Equipment, appliances, machinery, appliances, implant, in vitro reagent or calibrator, software, material or other similar or related items. These objects are. --- Disease diagnosis, prevention, monitoring, treatment or mitigation; --- Injury diagnosis, monitoring, treatment, mitigation or compensation; --- Study the anatomy or a physiological process, replace or adjust; --- Support or sustain life; --- Control of conception; --- Sterilization of medical devices; --- Based on a sample taken from the body of in vitro examination of ways to provide medical information. Its role in the design of the main body surface or in vivo effect is not pharmacological, immunological or metabolic means available, but these may have It means to participate and play a supporting role. [YY/T 0287-2003, the definition 3.7] Note. This is defined by YY/T 0287-2003, developed by the GHTF (GHTF2002). 3.24 Measuring chain measuringchain Series feature measurement apparatus or measurement system, which constitutes the measurement signal from the input (measured by the magnitude) to the output (measurement result) of path. 3.25 Microbe microorganism Under a microscope to see the small individuals, including bacteria, fungi, protozoa and viruses. Note. Specific criteria may not need to inactivate all the microorganisms to prove the effect of the sterilization process, according to the above definition to confirm the sterilization process and/or normally Regulatory control. [GB/T 19971-2015, the definition 2.26] 3.26 Heat moistheat Steam or liquid water in the presence of water in the manner of thermal energy to achieve the purpose of inactivation of microorganisms. 3.27 Non-condensable gases non-condensablegas Air and/or other gas saturated steam process conditions can not be liquefied. 3.28 Run identification operationalqualification; OQ Proving devices installed by running the program is run within a predetermined limit, and the formation process of the file. [GB/T 19971-2015, the definition 2.27] 3.29 Operating cycle operatingcycle All stages of the program in accordance with the provisions of the order execution. [IEC 61010-2-040.2005] 3.30 Packaging systems packagingsystem Sterile barrier system and protective packaging portfolio. [GB/T 19971-2015, the definition 2.28] 3.31 Performance appraisal performancequalification; PQ Proof device has been installed according to procedures and operations, according to predetermined criteria throughout the production to meet the technical specifications of the product and form Process file. [GB/T 19971-2015, the definition 2.30] 3.32 Precautions preventiveaction Measures to eliminate potential nonconformity or other potentially undesirable situation reason taken. Note 1.A potential failure can have several causes. Note 2.Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence. [GB/T 19000-2008, the definition 3.6.4] 3.33 Sterilizing time plateauperiod Equilibration time plus hold time. 3.34 Process challenge device processchalengedevice; PCD Designed to simulate product to be sterilized, and sterilization process to determine the formation of the resistance for the effective performance of the estimating process. [GB/T 19971-2015, the definition 2.33] 3.35 Process parameters processparameter Specified by the process variable value obtained. Note. The sterilization process specifications include process parameters and their tolerances. [GB/T 19971-2015, the definition 2.34] 3.36 Process variables processvariable Conditions within the scope of the sterilization process, the change can affect the germicidal efficacy. Example. time, temperature, pressure, concentration, humidit... ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.

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