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GB 18280.1-2015: Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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GB 18280-2000	RFQ	ASK	6 days	Sterilization of health care products. Requirement for validation and routine control. Radiation sterilization	Obsolete

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GB 18280.1-2015: Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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Sterilization of health care products - Radiation - Part 1.Requirements for 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 Partly replace GB 18280-2000 Radiation Sterilization of health care products Part 1.Medical device sterilization process development, Validation and routine control Sterilizationofhealthcareproducts-Radiation-Part 1. Requirementsfordevelopment, validationandroutinecontrolofa (ISO 11137-1.2006, IDT) Issued on. 2017-07-01 2015-12-31 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 Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Quality Management System Elements 7 5 sterilization characterization factor 7 Characteristics of processes and equipment 6 Description 8 7 9 Product Definition 8 9 Process Definition 9 Confirm 10 10 Routine monitoring and control 12 11 sterile product release 13 12 process to maintain the effectiveness of 13 Appendix A (informative) Guide 16 References 27

Foreword

All technical content in this Part of GB 18280 is mandatory. GB 18280 "Radiation Sterilization of health care products" is divided into the following sections. --- GB 18280.1 Radiation Sterilization of health care products - Part 1.Development of medical equipment sterilization process, validation and routine control System requirements; --- GB 18280.2 Sterilization of health care products - Radiation - Part 2.Establish sterilization dose; --- GB/T 18280.3 Radiation Sterilization of health care products - Part 3.dose measurement guide. This is Part 1 GB 18280's. This section drafted in accordance with GB/T 1.1-2009 given rules. This portion instead of GB 18280-2000 "Sterilization of health care products Requirements for validation and routine control of radiation sterilization", and GB 18280-2000 compared to the main technical content changes are as follows. --- Increasing the sterilization factor characterization; --- Increased process characteristics and description of the device; --- Increased product definition; --- Increased process definition; --- Increased sterilization release; --- To increase the effectiveness of process control. This section uses the translation method identical with ISO 11137-1.2006 "Sterilization of health care products - Radiation - Part 1.Medical Devices Off Bacteria development process, validation and routine control. " The correspondence between the consistency of the international normative documents referenced in our country with the following documents. --- GB/T 19022-2003 Measurement management systems for measurement processes and measuring equipment (ISO 10012.2003, IDT); --- GB/T 19973.1-2005 Sterilization of health care products - Microbiological methods - Part 1.The total number of microorganisms on the product Estimate (ISO 11737-1.1994, IDT); --- GB /learning methods - Part 2 T 19973.2-2005 microbial sterilization of medical devices. sterility test confirmed the sterilization process (ISO 11737-2.1998, IDT). 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 is drafted. Beijing Radiation Application Research Center, Shenzhen Jinpeng source of radiation Technology Co., Ltd., the State Food and Drug Administration Administration of Guangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Hu Jinhui, Linnai Jie, Xu Honglei, Chen Qiang, spear Bao, Zhang Yue. This part of the standard replaces the previous editions are. --- GB 18280-2000.

introduction

Sterile medical devices is a non-living micro-organisms products. International Standard specifies confirm the sterilization process and routine control of when Necessary medical equipment provided in the form of sterile, should be sterilized before its various undesired microorganisms to minimize contamination. Even medical devices Mechanical products to meet the quality management system (for example. YY/T 0287) under standard manufacturing conditions requirements produced before sterilization will bring A small amount of micro-organisms, such products are non-sterile products. Purpose of sterilization is to inactivate microorganisms, so that 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. This section describes the requirements for radiation sterilization of medical devices program; to meet these requirements, we can provide suitable microorganisms bactericidal activity Radiation sterilization of medical devices; In addition, to ensure sterilization activities are reliable and repeatable results sterilization is predictable, Therefore, the probability of sterilization in the presence of viable microorganisms on the product was very low. Sterility assurance level (SAL) developed by the regulatory authorities determine Fixed, depending on the country (such as EN556-1 and ANSI/AAMIST67). General requirements for design and development, production, installation and services such as quality management system, see GB/T 19001, see the special requirements of YY/T 0287.These quality management system standard that the effectiveness of some of the manufacturing process can not fully follow through product inspection and testing Verification, sterilization is such a special process. Therefore, prior to sterilization sterilized confirm fulfill routine monitoring and maintenance. Implementation of appropriate sterilization confirmation, precise control of the sterilization process, not a sterile product and the only reliable guarantee of compliance with the intended use. It should also be Consider the following aspects. a) the microbiological status of raw materials and/or components used; b) for routine control and validation of 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. This section describes ensure proper implementation of activities related to the radiation sterilization process requirements. These efforts are to prove in a predetermined dose The range, the radiation process can be stably supplied sterile products, these procedures should be documented. These requirements are in the body of this section. Guidelines in Appendix A, instead of the standard text, not to the auditor the audit table. For the convenience of Understanding requirements guide provides explanations and methods. Methodology Guide did not give, if can also meet the requirements of this section to be use. 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. This activity is part of the required combination in accordance with a certain order, but not to Evaluated in order to implement these activities consistent with the order they appear in the standard. Development and implementation of the validation process may be repeated, so this Some necessary activities are not necessarily contiguous. The implementation of different activities may include a number of separate individuals and/or organizations, each of them a May undertake one or more activities. This section does not specify a particular individual or organization to perform an activity. Radiation Sterilization of health care products Part 1.Medical device sterilization process development, Validation and routine control 1 Scope 1.1 GB 18280 of the provisions of this part of the development of medical devices in the radiation sterilization process, validation and routine control. Note. This section applies to medical devices, but these requirements and guidelines can be used to provide other products and equipment. This section applies to the use of the following sources of radiation irradiation apparatus. a) use of radionuclides cobalt-60 or cesium-137; b) electron beam emitted from an electron accelerator; c) X-rays emitted by the X-ray generator. The provisions of section 1.2 are not used to inactivate such as scrapie, bovine spongiform encephalopathy, g - Jakob disease and other spongiform encephalopathies open pathogens sterilization process Hair, confirmed that the conventional control. For processing by such pathogens potentially contaminated material in a particular country, there are detailed provisions introduced. Example. ISO 22442-1, ISO 22442-2 and ISO 22442-3. 1.2.1 This section does not specify detailed in sterile medical equipment requirements. Note. Please specify the attention of medical equipment sterile regional and national requirements, such as. EN556-1 or ANSI/AAMIST67. 1.2.2 This section does not provide for medical device production process control of the quality management system. Note. This section does not need to establish a complete quality management system during manufacture, but the elements of a quality management system to control the sterilization process at least with reference to Part Sub-terms (see Chapter 4) applies. Taking into account the quality management system standards (see YY/T 0287) including a sterilization process for medical devices production The whole process of application. Some regional and national regulations on medical devices, it is required to implement a complete quality management system by the third-party audit system. 1.2.3 This section does not require the use of biological indicators in identifying and monitoring radiation sterilization, and does not require the use of a sterile examination Pharmacopoeia The release of product. 1.2.4 This section does not specify the irradiation plant design, operations related to occupational safety requirements. Note. Some countries should take into account the radiation-related occupational safety regulations. 1.2.5 The provisions of this section does not already used the sterilized and re-processed medical devices requirements. 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. GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2.Establish sterilization dose (ISO 11137-2.2006, IDT) YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT) ISO 10012-1 Quality assurance requirements for measuring equipment - Part 1.Metrological confirmation system for measuring equipment (Qualityassurance requirementsformeasuringequipment-Part 1.Metrologicalconfirmationsystemformeasuring equipment) Sterilization Microbiological methods - Part 1 ISO 11737-1 medical devices. the total number of microorganisms on the product estimate (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) 3 Terms and Definitions The following terms and definitions apply to this document. 3.1 Absorbed dose absorbeddose Dose dose Transfer to the dose of ionizing radiation on the substance of mass units. Note 1.The unit of absorbed dose is Gy (Gy), 1Gy = 1J/kg (= 100rad). Note 2.This section refers dose absorbed dose. 3.2 Bioburden bioburden A product/or and/or wherein the total number of viable microorganisms and sterile barrier system. [ISO /T S11139.2006] 3.3 Biological indicators biologicalindicator Sterilization procedure contains provisions have to determine the resistance of living micro-organisms test systems. [ISO /T S11139.2006] 3.4 Calibration calibration Under specified conditions, to establish the magnitude of the measuring instrument or measuring system, as indicated, or on behalf of the material measure or a reference to the substance of value, And by the corresponding standard reproducible set of operations between values. [VIM.1993, definitions 6.11] 3.5 Change control changecontrol Suitability assessment and determine plans for products or programs made changes. [ISO /T S11139.2006] 3.6 Correct correction Measures to eliminate substandard discovered. NOTE. A correction can be implemented together along with corrective measures. [GB/T 19000-2008] 3.7 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. Note 3.There is difference between corrective and corrective action. [GB/T 19000-2008] 3.8 D value Dvalue; D10value Under specified conditions, the inactivation time 90% of the total number of test organisms required or dose. Note. In the GB 18280, D value refers to a 90% reduction of microbial contamination of the dose required. [ISO /T S11139.2006] 3.9 Development development Process Specification activities elaborating. [ISO /T S11139.2006] 3.10 Dose distribution test dosemapping Under the conditions prescribed dose of radioactive material is distributed and variability measurements. 3.11 Dosimeter dosimeter Of radiation may recur, device or system response measurable. Dose measurement system can be used to measure the specific absorption dose. [ISO /T S11139.2006] 3.12 Dosimetry dosimetry Dose measuring absorbed dose. 3.13 Establish establish By determining the theoretical evaluation, and after trials. [ISO /T S11139.2006] 3.14 Failure fault One or more process parameters exceed the stated tolerances. [ISO /T S11139.2006] 3.15 Health care products healthcareproduct (s) Medical devices, including in vitro diagnostic medical devices or pharmaceutical products, including biopharmaceuticals. [ISO /T S11139.2006] 3.16 Installation identification instalationqualification; IQ The process of obtaining evidence and documented evidence to prove that equipment has been delivered and installed according to the technical specifications. [ISO /T S11139.2006] 3.17 Irradiation container irradiationcontainer Loading product container through a radiation irradiation apparatus. Note. The container can be irradiated transportation, carts, trays, boxes of products, pallets or other containers. 3.18 Irradiation operators irradiatoroperator Responsible for product irradiated body. 3.19 The maximum acceptable dose maximumacceptabledose Process specifications prescribed dose, as the maximum dose that can be applied to the provision of products without detriment to product safety, quality and performance. 3.20 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 projects It is. --- Disease diagnosis, prevention, monitoring, treatment or mitigation; --- Injury diagnosis, monitoring, treatment, mitigation or compensation; --- Study the anatomy or a physiological process, replacement or modification or support; --- 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] 3.21 Microbe microorganism Under microscopic entities, including. bacteria, fungi, protozoa and viruses. NOTE. After confirming and/or conventional control, specific criteria may not require sterilization inactivated confirmed the above definition to identify all types of microorganisms have Effectiveness. [ISO /T S11139.2006] 3.22 Run identification operationalqualification; OQ To obtain evidence and to document the process, in accordance with proven equipment to run the program using the equipment, installed device is within a predetermined range Within a run. [ISO /T S11139.2006] 3.23 Performance appraisal performancequalification; PQ To obtain evidence and to document the process to demonstrate that the equipment is installed and running by running the program, and can steady a predetermined standard Production to meet product specification requirements. [ISO /T S11139.2006] 3.24 Precautions preventiveaction Measures to eliminate potential nonconformity or other undesirable potential situation reasons 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] 3.25 Original Manufacturer primarymanufacturer Responsible for the design and manufacture of medical devices, when the product is on the market, the safety and performance of the product is responsible for the organization. 3.26 Process interrupt processinterruption Intentional or unintentional stops during irradiation. 3.27 Process parameters processparameter Predetermined process variable value. Note. The sterilization process specifications include process parameters and their tolerances. [ISO /T S11139.2006] 3.28 Process variables processvariable Conditions within the scope of the sterilization process, the change may be change in the sterilization effectiveness. Example. time, temperature, pressure, concentration, humidity, wavelength. 3.29 Processing category processingcategory Group together different products can be sterilized composition. NOTE. The product can be based on a combination of product composition, density or dose requirements. 3.30 Products product Outcome of the process. [GB/T 19000-2008] NOTE. For this part, the product is tangible and can be raw materials, intermediates, assembly member or health care products. 3.31 Product Family productfamily You can use the same dose of radiation sterilization of different products thereof. 3.32 Requalification requalification As part of the validation process confirmed by a designated qualified and duration of re. [ISO /T S11139.2006] 3.33 Service supply services Supply equipment necessary for the operation of external resources. Example. electricity, water, compressed air, drainage. 3.34 Specification specification Approved document stated requirements. 3.35 Regulations specify Elaborated in the document approved. [ISO /T S11139.2006] 3.36 Sterile sterile No live microorganisms. [ISO /T S11139.2006] 3.37 Aseptic sterility No viable microorganisms state. Note. In practice, the presence of microorganisms can not be confirmed that no such absolute statement, see the "sterilization" (3.39). [ISO /T S11139.2006] 3.38 Sterility assurance level sterilityassurancelevel; SAL The probability of a single viable microorganism present on product after sterilization unit. Note. The term "SAL" use value, which normally is 10-6 or 10-3.When we applied this measure to the sterility assurance level of 10-6 SAL have lower Thereby providing a value greater than 10-3 sterility assurance level SAL. [ISO /T S11139.2006] 3.39 Sterilization sterilization Make the product free of viable microorganisms confirmed process. NOTE. In the sterilization process, the nature of microbial inactivation is exponential relationship was; so a single product can be used to represent the microbial survival probability. although This can be reduced to very low probability, but can not be reduced to zero, see "sterility assurance level" (3.38). [ISO /T S11139.2006] 3.40 Sterilization dose sterilizationdose Reaches a predetermined minimum dose required sterile. 3.41 Sterilization process sterilizationprocess Sterility requirements specified range of activities required or operations. Note. This series of activities include pretreatment products (if needed), under specified conditions, exposed to the sterilizing factor and necessary post-processing. Sterilized Cheng does not include any cleaning, disinfection and sterilization before packaging operations. [ISO /T S11139.2006] 3.42 Sterilization factor sterilizingagent Under specified conditions, sufficient bactericidal activity, so that the material is sterilized sterility physical or chemical substance, or a combination thereof. [ISO /T S11139.2006] 3.43 Sterility testing testforsterility After the product is exposed to the sterilization process, in the national pharmacopoeia finished product specified in technical operations. [ISO /T S11139.2006] 3.44 Sterility testofsterility As part of the product or the determination unit with or without the test carried live microorganisms, as development, validation or requalification part Technical operations is completed. [ISO /T S11139.2006] 3.45 Additional dose transitdose Product or non-radiation during irradiation position and irradiation position of the mobile product absorbed dose. 3.46 Measurement Uncertainty uncertaintyofmeasurement Characterization reasonably be attributed to the dispersion of the parameters, and results of a measurement of the value of the associated. [VIM.1993] 3.47 Confirm validation For the establishment of a sustainable production process in line with expectations of product acquisition, recording and documenting the results documented procedures. [ISO /T S11139.2006] Quality management system elements 4.1 File 4.1.1 The sterilization process should provide for the development, validation, routine control and product approval procedures. 4.1.2 This section relevant documents and records shall be reviewed and approved by designated personnel files, documents and records should be consistent with YY/T 0287-2003 Applicable provisions. 4.2 Management Responsibilities 4.2.1 Face the duties and rights and satisfy requirements of this section shall be defined. In accordance with YY/T 0287-2003 applicable provisions of this Kinds of responsibilities and rights should be granted to competent people. 4.2.2 If the requirements of this group by having a plurality of individual commitment to the implementation of quality management system, shall be documented and responsibilities of each party right. 4.3 Product Realization 4.3.1 should provide that procurement procedures. These procedures should be consistent with YY/T 0287-2003 the applicable provisions. 4.3.2 should provide product identification and traceability program. These procedures should be consistent with YY/T 0287-2003 the applicable provisions. 4.3.3 shall be specified to meet the requirements of this part of the instrument comprises a tool for testing purposes of calibration procedures for all devices, the program should In line YY/T 0287-2003 or applicable provisions of ISO 10012-1. 4.3.4 to develop a sterilization process, validation and routine control of dose measurements should be traceable to national or international standards and to determine the dosimetry Uncertainty levels. 4.4 Measurement, analysis and improvement of non-conforming product control --- Substandard products and corrective controls, corrective action and preventive action procedures shall be defined. These procedures should be consistent with YY/T 0287- Applicable provisions of 2003. 5 sterilization factor characterization 5.1 Sterilization factor 5.1.1 should specify the type of radiation used in sterilization processing. 5.1.2 For electron beam or X-ray, should provide the energy level of the electron beam. If the energy level of the electron beam is used or more than 10MeV Energy generating X-rays above 5MeV, should cause the product to assess the possibility of induced radioactivity generated. Results and principles referenced assessment should Documented. 5.2 Sterilization Effectiveness Radiation or radiation inactivation of microorganisms used in the sterilization process, has been studied extensively in the literature. Above document provides procedures Knowledge variables affect microbial inactivation method. This section does not require inactivation of microorganisms involved in comprehensive research. 5.3 Material Effect Radiation for a variety of materials used in the manufacture of medical devices has been the influence of the relevant documents related discussion, the literature on the use of Design and development of radiation sterilization of medical devices is valuable. This section does not require the impact of research material, but requires radiation Research on the impact of the product (see 8.1). 5.4 Environmental Considerations You should evaluate the potential impact of operational radiation sterilization process on the environment, and environmental protection measures should be identified. If there are potential impacts should the text Member of the assessment; if control measures can be identified, they should implement this provision and control measures. 6 features described processes and equipment 6.1 Process Variable identification process, and to require them to monitor and control approach. 6.2 Device 6.2.1 Method provisions irradiation apparatus and operation. If necessary (see 12.5.1) specification revision irradiation... ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.

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