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GB 18278.1-2015 English PDF (GB18278.1-2015)

GB 18278.1-2015 English PDF (GB18278.1-2015)

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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

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 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 prod...

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