Shop Inspection Requirements for Instruments Items
Receiving Inspection Q. Procedure
6.2.2Receiving of material
Received material shall accordance toPurchasingQuality ManagementProceduredoc. #QP-ADPU-001
6.1.2QA Department shallbaseon the cost incur to determine the incoming inspection method andlevel as below:
6.1.2.1If there is equipment and human resource limitation, inspection can be carrying out at supplier premises.
6.1.4The entire inspector shall be trained and qualified on handling of inspection equipment and inspection method.
6.2Incoming Inspection.5.1Incoming QC inspector shall refer to “Goods Received Note” and based on the Sampling table to pull the sample accordingly. Inspection method is solely based on visual inspection. The inspection items shall carry out based on criteria defined at the“Incoming Inspection Report”.
产品出库检验注意事项及流程
产品出库检验注意事项及流程英文回答：Product Outbound Inspection Precautions and Procedures.When it comes to product outbound inspection, there are several important considerations and steps to follow to ensure the quality and accuracy of the products being shipped. In this response, I will outline the key points to keep in mind and provide examples to illustrate the process.1. Proper Documentation:Before starting the inspection, it is crucial to haveall the necessary documentation in place. This includes the packing list, shipping labels, and any relevant quality control documents. These documents serve as a reference and help ensure that the correct products are being inspected and shipped.For example, I once had to inspect a shipment of electronic devices. I made sure to have the packing list and the specifications of the devices handy to compare them with the actual products during the inspection.2. Visual Inspection:The first step in the outbound inspection process is to conduct a visual inspection of the products. This involves checking for any visible damages, defects, or discrepancies in packaging. It is important to pay attention to details and compare the products with the provided specifications.For instance, during a visual inspection of a batch of clothing items, I noticed that some of the garments had loose threads and stains. I immediately flagged these items for further inspection and communicated the issue to the relevant department.3. Functional Testing:Depending on the nature of the products, functionaltesting may be necessary to ensure they meet the required standards. This step involves checking if the products work as intended and perform their intended functions.For example, when inspecting a shipment of smartphones, I would test their various features such as the camera, touchscreen, and battery life to ensure they arefunctioning properly.4. Quantity Verification:Another crucial aspect of outbound inspection is verifying the quantity of products being shipped. This involves comparing the actual number of products with the quantity stated in the packing list or purchase order.For instance, when inspecting a shipment of toys, I would count the number of items and cross-check it with the packing list. If there is any discrepancy, such as missing or extra items, I would investigate the issue further and take appropriate action.5. Packaging and Labeling:During the inspection, it is important to check the packaging and labeling of the products. This includes ensuring that the products are properly packed, labeled, and meet any specific packaging requirements.For example, when inspecting a shipment of food products, I would check if the packaging is intact, the labels are accurate, and the products are properly sealed to maintain their freshness and quality.6. Documentation and Reporting:After completing the inspection, it is essential to document the findings and report any issues or discrepancies. This information is crucial for record-keeping and for taking corrective actions if needed.For instance, I would prepare an inspection report detailing the inspection process, any defects or damages found, and any actions taken. This report would be sharedwith the relevant stakeholders, such as the quality control team or the supplier, to address the issues identified.中文回答：产品出库检验注意事项及流程。
跨境电商常用外贸英语900句：商品检验CommodityInspection外贸英语+商务英语
跨境电商常用外贸英语900句：商品检验CommodityInspection外贸英语+商务英语商品检验 Commodity Inspection(一)Shall we take up the question of inspection today?今天咱们讨论商品检验问题吧。
The inspection of commodity is not an easy job.商检工作不是那么简单。
Mr. Black is talking with the Chinese importer about inspecting the goods.布莱克先生与中方进口商就商品检验问题进行洽谈。
As an integral part of the contract, the inspection of goods has its special importance.作为合同里的一个组成部分，商品检验具有特殊的重要性。
We should inspect this batch of porcelainware to see if there is any breakage.我们要检查一下这批瓷器是否有破损的。
The exporters have the right to inspect the export goods before delivery to the shipping line.出口商在向船运公司托运前有权检验商品。
The inspection should be completed within a month after the arrival of the goods.商品检验工作在到货后一个月内完成。
How should we define the inspection rights?商检的权力怎样加以明确呢?I'm worried that there might be some disputes over the results of inspection.我担心对商检的结果会发生争议。
手袋箱包外贸QC常用必备英语
Thisdocumentspecifiesthegeneralqualityrequirementsfor“SleepingBag”andothersimilarproducts.Itisusedasageneral guidelineforinspectionifclientshavenotdefinedtheirrequirement.此文件为针对箱包及类似产品验货的通用标准。
如果客户没有特别的要求，在此定为通用的验货指南1. InspectionCriteriaofProduct/Package产品/包装验货标准Product:产品✧Mustbewithoutanyunsafedefectforusing;不允许有在实际使用中任何对使用者造成伤害的缺陷；✧Shouldbefreeofdamaged,broken,scratch,crackleetc.Cosmetic/Aestheticsdefect;不应有任何损坏，破碎，擦伤，或碎裂等外观缺陷；✧Mustbeconformtotheshippingmarketlegalregulation/client’srequirement;必须符合销往国当地的法规以及客户的要求；✧Theconstruction,appearance,cosmeticsandmaterialofallunitsshouldcomplywithclient’srequirement/approvedsamples;产品的结构，外观，材料等必须符合客户的要求或与样品保持一致；✧Allunitsshouldhavefullfunctioncomplyingwithclient’srequirement/approvedsamples;产品功能必须符合客户的要求或与样品保持一致；✧Themarking/labelonunitshouldbelegalandclear.产品上的标记/标签必须符合法规要求且清晰明确。
软件测试词汇(英语)
AAcceptance Testing:T esting conducted to enable a user/customer to determine whether to accept a software product. Normally performed to validate the software meets a set of agreed acceptance criteria.Accessibility Testing:Verifying a product is accessible to the people having disabilities (deaf, blind, mentally disabled etc.).Ad Hoc Testing:A testing phase where the tester tries to 'break' the system by randomly trying the system's functionality. Can include negative testing as well. See also Monkey Testing.Agile Testing:Testing practice for projects using agile methodologies, treating development as the customer of testing and emphasizing a test-first design paradigm. See also T est Driven Development.Application Binary Interface (ABI):A specification defining requirements for portability of applications in binary forms across defferent system platforms and environments. Application Programming Interface (API):A formalized set of software calls and routines that can be referenced by an application program in order to access supporting system or network services.Automated Software Quality (ASQ):The use of software tools, such as automated testing tools, to improve software quality.Automated Testing:•Testing employing software tools which execute tests without manual intervention.Can be applied in GUI, performance, API, etc. testing.•The use of software to control the execution of tests, the comparison of actual outcomes to predicted outcomes, the setting up of test preconditions, and other test control and test reporting functions.BBackus-Naur Form:A metalanguage used to formally describe the syntax of a language. Basic Block:A sequence of one or more consecutive, executable statements containing no branches.Basis Path Testing:A white box test case design technique that uses the algorithmic flow of the program to design tests.Basis Set:The set of tests derived using basis path testing.Baseline:The point at which some deliverable produced during the software engineering process is put under formal change control.Beta Testing:Testing of a rerelease of a software product conducted by customers. Binary Portability Testing:Testing an executable application for portability across system platforms and environments, usually for conformation to an ABI specification.Black Box Testing:Testing based on an analysis of the specification of a piece of software without reference to its internal workings. The goal is to test how well thecomponent conforms to the published requirements for the component.Bottom Up Testing:An approach to integration testing where the lowest level components are tested first, then used to facilitate the testing of higher level components. The process is repeated until the component at the top of the hierarchy is tested. Boundary Testing:T est which focus on the boundary or limit conditions of the software being tested. (Some of these tests are stress tests).Bug:A fault in a program which causes the program to perform in an unintended or unanticipated manner.Boundary Value Analysis:BVA is similar to Equivalence Partitioning but focuses on "corner cases" or values that are usually out of range as defined by the specification. his means that if a function expects all values in range of negative 100 to positive 1000, test inputs would include negative 101 and positive 1001.Branch Testing:Testing in which all branches in the program source code are tested at least once.Breadth Testing:A test suite that exercises the full functionality of a product but does not test features in detail.CCAST:Computer Aided Software Testing.Capture/Replay Tool:A test tool that records test input as it is sent to the software under test. The input cases stored can then be used to reproduce the test at a later time. Most commonly applied to GUI test tools.CMM:The Capability Maturity Model for Software (CMM or SW-CMM) is a model for judging the maturity of the software processes of an organization and for identifying the key practices that are required to increase the maturity of these processes.Cause Effect Graph:A graphical representation of inputs and the associated outputs effects which can be used to design test cases.Code Complete:Phase of development where functionality is implemented in entirety; bug fixes are all that are left. All functions found in the Functional Specifications have been implemented.Code Coverage:An analysis method that determines which parts of the software have been executed (covered) by the test case suite and which parts have not been executed and therefore may require additional attention.Code Inspection:A formal testing technique where the programmer reviews source code with a group who ask questions analyzing the program logic, analyzing the code with respect to a checklist of historically common programming errors, and analyzing its compliance with coding standards.Code Walkthrough:A formal testing technique where source code is traced by a group with a small set of test cases, while the state of program variables is manually monitored, to analyze the programmer's logic and assumptions.Coding:The generation of source code.Compatibility Testing:T esting whether software is compatible with other elements of a system with which it should operate, e.g. browsers, Operating Systems, or hardware. Component:A minimal software item for which a separate specification is available.Component Testing:See Unit Testing.Concurrency Testing:Multi-user testing geared towards determining the effects of accessing the same application code, module or database records. Identifies and measures the level of locking, deadlocking and use of single-threaded code and locking semaphores.Conformance Testing:The process of testing that an implementation conforms to the specification on which it is based. Usually applied to testing conformance to a formal standard.Context Driven Testing:The context-driven school of software testing is flavor of Agile Testing that advocates continuous and creative evaluation of testing opportunities in light of the potential information revealed and the value of that information to the organization right now.Conversion Testing:T esting of programs or procedures used to convert data from existing systems for use in replacement systems.Cyclomatic Complexity:A measure of the logical complexity of an algorithm, used in white-box testing.DData Dictionary:A database that contains definitions of all data items defined during analysis.Data Flow Diagram:A modeling notation that represents a functional decomposition of a system.Data Driven Testing:Testing in which the action of a test case is parameterized by externally defined data values, maintained as a file or spreadsheet. A common technique in Automated Testing.Debugging:The process of finding and removing the causes of software failures. Defect:Nonconformance to requirements or functional / program specification Dependency Testing:Examines an application's requirements for pre-existing software, initial states and configuration in order to maintain proper functionality.Depth Testing:A test that exercises a feature of a product in full detail.Dynamic Testing:T esting software through executing it. See also Static Testing.EEmulator:A device, computer program, or system that accepts the same inputs and produces the same outputs as a given system.Endurance Testing:Checks for memory leaks or other problems that may occur with prolonged execution.End-to-End testing:Testing a complete application environment in a situation that mimics real-world use, such as interacting with a database, using network communications, or interacting with other hardware, applications, or systems if appropriate.Equivalence Class:A portion of a component's input or output domains for which the component's behaviour is assumed to be the same from the component's specification. Equivalence Partitioning:A test case design technique for a component in which test cases are designed to execute representatives from equivalence classes.Exhaustive Testing:Testing which covers all combinations of input values and preconditions for an element of the software under test.Functional Decomposition:A technique used during planning, analysis and design; creates a functional hierarchy for the software.Functional Specification:A document that describes in detail the characteristics of the product with regard to its intended features.Functional Testing:See also Black Box Testing.•Testing the features and operational behavior of a product to ensure they correspond to its specifications.•Testing that ignores the internal mechanism of a system or component and focuses solely on the outputs generated in response to selected inputs and execution conditions.GGlass Box Testing:A synonym for White Box Testing.Gorilla Testing:Testing one particular module,functionality heavily.Gray Box Testing:A combination of Black Box and White Box testing methodologies: testing a piece of software against its specification but using some knowledge of its internal workings.HHigh Order Tests:Black-box tests conducted once the software has been integrated.IIndependent Test Group (ITG):A group of people whose primary responsibility is software testing,Inspection:A group review quality improvement process for written material. It consists of two aspects; product (document itself) improvement and process improvement (of both document production and inspection).Integration Testing:T esting of combined parts of an application to determine if they function together correctly. Usually performed after unit and functional testing. This type of testing is especially relevant to client/server and distributed systems.Installation Testing:Confirms that the application under test recovers from expected or unexpected events without loss of data or functionality. Events can include shortage of disk space, unexpected loss of communication, or power out conditions.JKLLoad Testing:See Performance Testing.Localization Testing:This term refers to making software specifically designed for a specific locality.Loop Testing:A white box testing technique that exercises program loops.MMetric:A standard of measurement. Software metrics are the statistics describing the structure or content of a program. A metric should be a real objective measurement of something such as number of bugs per lines of code.Monkey Testing:Testing a system or an Application on the fly, i.e just few tests here and there to ensure the system or an application does not crash out.NNegative Testing:T esting aimed at showing software does not work. Also known as "test to fail". See also Positive Testing.OPPath Testing:Testing in which all paths in the program source code are tested at least once.Performance Testing:Testing conducted to evaluate the compliance of a system or component with specified performance requirements. Often this is performed using an automated test tool to simulate large number of users. Also know as "Load Testing". Positive Testing:Testing aimed at showing software works. Also known as "test to pass". See also Negative Testing.QQuality Assurance:All those planned or systematic actions necessary to provide adequate confidence that a product or service is of the type and quality needed and expected by the customer.Quality Audit:A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.Quality Circle:A group of individuals with related interests that meet at regular intervals toconsider problems or other matters related to the quality of outputs of a process and to the correction of problems or to the improvement of quality.Quality Control:The operational techniques and the activities used to fulfill and verify requirements of quality.Quality Management:That aspect of the overall management function that determines and implements the quality policy.Quality Policy:The overall intentions and direction of an organization as regards quality as formally expressed by top management.Quality System:The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.RRace Condition:A cause of concurrency problems. Multiple accesses to a shared resource, at least one of which is a write, with no mechanism used by either to moderate simultaneous access.Ramp Testing:Continuously raising an input signal until the system breaks down.Recovery Testing:Confirms that the program recovers from expected or unexpected events without loss of data or functionality. Events can include shortage of disk space, unexpected loss of communication, or power out conditions.Regression Testing:Retesting a previously tested program following modification to ensure that faults have not been introduced or uncovered as a result of the changes made.Release Candidate:A pre-release version, which contains the desired functionality of the final version, but which needs to be tested for bugs (which ideally should be removed before the final version is released).S<>Sanity Testing:Brief test of major functional elements of a piece of software to determine if its basically operational. See also Smoke Testing.<>Scalability Testing:Performance testing focused on ensuring the application under test gracefully handles increases in work load.<>Security Testing:T esting which confirms that the program can restrict access to authorized personnel and that the authorized personnel can access the functions available to their security level.<>Smoke Testing:A quick-and-dirty test that the major functions of a piece of software work. Originated in the hardware testing practice of turning on a new piece of hardware forthe first time and considering it a success if it does not catch on fire.<>Soak Testing:Running a system at high load for a prolonged period of time. For example, running several times more transactions in an entire day (or night) than would be expected in a busy day, to identify and performance problems that appear after a large number of transactions have been executed.<>Software Requirements Specification:A deliverable that describes all data, functional and behavioral requirements, all constraints, and all validation requirements for software/<>Software Testing:A set of activities conducted with the intent of finding errors in software.<>Static Analysis:Analysis of a program carried out without executing the program.Static Analyzer:A tool that carries out static analysis.<>Static Testing:Analysis of a program carried out without executing the program.Storage Testing:T esting that verifies the program under test stores data files in the correct directories and that it reserves sufficient space to prevent unexpected termination resulting from lack of space. This is external storage as opposed to internal storage. Stress Testing:Testing conducted to evaluate a system or component at or beyond the limits of its specified requirements to determine the load under which it fails and how. Often this is performance testing using a very high level of simulated load.Structural Testing:T esting based on an analysis of internal workings and structure of a piece of software. See also White Box Testing.System Testing:Testing that attempts to discover defects that are properties of the entire system rather than of its individual components.Testability:The degree to which a system or component facilitates the establishment of test criteria and the performance of tests to determine whether those criteria have been met.Testing:•The process of exercising software to verify that it satisfies specified requirements and to detect errors.The process of analyzing a software item to detect the differences between existing and required conditions (that is, bugs), and to evaluate the features of the software item (Ref. IEEE Std 829).•The process of operating a system or component under specified conditions, observing or recording the results, and making an evaluation of some aspect of the system or component.Test Automation:See Automated Testing.Test Bed:An execution environment configured for testing. May consist of specifichardware, OS, network topology, configuration of the product under test, other application or system software, etc. The Test Plan for a project should enumerated the test beds(s) to be used.Test Case:•Test Case is a commonly used term for a specific test. This is usually the smallest unit of testing. A Test Case will consist of information such as requirements testing, test steps, verification steps, prerequisites, outputs, test environment, etc.• A set of inputs, execution preconditions, and expected outcomes developed for a particular objective, such as to exercise a particular program path or to verify compliance with a specific requirement.Test Driven Development:Testing methodology associated with Agile Programming in which every chunk of code is covered by unit tests, which must all pass all the time, in an effort to eliminate unit-level and regression bugs during development. Practitioners of TDD write a lot of tests, i.e. an equal number of lines of test code to the size of the production code.Test Driver:A program or test tool used to execute a tests. Also known as a Test Harness. Test Environment:The hardware and software environment in which tests will be run, and any other software with which the software under test interacts when under test including stubs and test drivers.Test First Design:Test-first design is one of the mandatory practices of Extreme Programming (XP).It requires that programmers do not write any production code until they have first written a unit test.Test Harness:A program or test tool used to execute a tests. Also known as a Test Driver. Test Plan:A document describing the scope, approach, resources, and schedule of intended testing activities. It identifies test items, the features to be tested, the testing tasks, who will do each task, and any risks requiring contingency planning. Ref IEEE Std 829.Test Procedure:A document providing detailed instructions for the execution of one or more test cases.Test Script:Commonly used to refer to the instructions for a particular test that will be carried out by an automated test tool.Test Specification:A document specifying the test approach for a software feature or combination or features and the inputs, predicted results and execution conditions for the associated tests.Test Suite:A collection of tests used to validate the behavior of a product. The scope of a Test Suite varies from organization to organization. There may be several T est Suites for a particular product for example. In most cases however a Test Suite is a high level concept, grouping together hundreds or thousands of tests related by what they are intended to test. Test Tools:Computer programs used in the testing of a system, a component of the system, or its documentation.Thread Testing:A variation of top-down testing where the progressive integration of components follows the implementation of subsets of the requirements, as opposed to theintegration of components by successively lower levels.Top Down Testing:An approach to integration testing where the component at the top of the component hierarchy is tested first, with lower level components being simulated by stubs. Tested components are then used to test lower level components. The process is repeated until the lowest level components have been tested.Total Quality Management:A company commitment to develop a process that achieves high quality product and customer satisfaction.Traceability Matrix:A document showing the relationship between Test Requirements and Test Cases.UUsability Testing:T esting the ease with which users can learn and use a product.Use Case:The specification of tests that are conducted from the end-user perspective. Use cases tend to focus on operating software as an end-user would conduct their day-to-day activities.Unit Testing:Testing of individual software components.VValidation:The process of evaluating software at the end of the software development process to ensure compliance with software requirements. The techniques for validation is testing, inspection and reviewing.Verification:The process of determining whether of not the products of a given phase of the software development cycle meet the implementation steps and can be traced to the incoming objectives established during the previous phase. The techniques for verification are testing, inspection and reviewing.Volume Testing:T esting which confirms that any values that may become large over time (such as accumulated counts, logs, and data files), can be accommodated by the program and will not cause the program to stop working or degrade its operation in any manner.WWalkthrough:A review of requirements, designs or code characterized by the author of the material under review guiding the progression of the review.White Box Testing:Testing based on an analysis of internal workings and structure of a piece of software. Includes techniques such as Branch Testing and Path T esting. Also known as Structural Testing and Glass Box Testing. Contrast with Black Box Testing. Workflow Testing:Scripted end-to-end testing which duplicates specific workflows which are expected to be utilized by the end-user.。
ASTM F2100-19美国医用口罩标准
Designation:F2100−19Standard Specification forPerformance of Materials Used in Medical Face Masks 1This standard is issued under the fixed designation F2100;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.A superscript epsilon (´)indicates an editorial change since the last revision or reapproval.1.Scope1.1This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.1.2This specification provides for the classification of medical face mask material performance.Medical face mask material performance is based on testing for bacterial filtration efficiency,differential pressure,sub-micron particulate filtra-tion efficiency,resistance to penetration by synthetic blood,and flammability.1.3This specification does not address all aspects of medi-cal face mask design and performance.This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties.This specification does not apply to regulated respiratory protection,which may be necessary for some healthcare services.1.4The values stated in SI units are to be regarded as standard.No other units of measurement are included in this standard.1.5The following precautionary caveat pertains only to the test methods portion,Section 9,of this specification:This standard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the user of this standard to establish appropriate safety,health,and environmental practices and determine the applicability of regulatory limitations prior to use.1.6This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for the Development of International Standards,Guides and Recom-mendations issued by the World Trade Organization Technical Barriers to Trade (TBT)Committee.2.Referenced Documents2.1ASTM Standards:2F1494Terminology Relating to Protective ClothingF1862Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed V olume at a Known Velocity)F2101Test Method for Evaluating the Bacterial Filtration Efficiency (BFE)of Medical Face Mask Materials,Using a Biological Aerosol of Staphylococcus aureusF2299Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres 2.2ANSI/ASQC Standard:3ANSI/ASQC Z1.4Sampling Procedures and Tables for In-spection by Attributes 2.3ISO Standard:4ISO 2859-1Sampling Plans for Inspection by Attributes 2.4European Standard:5EN 14683Medical Fask Masks—Requirements and Test Methods2.5Federal Standards:616CFR Part 1610Standard for the Flammability of Clothing Textiles29CFR Part 1910.1030Occupational Exposure to Blood-borne Pathogens:Final Rule42CFR Part 84Approval of Respiratory Protective Devices 3.Terminology3.1Definitions:3.1.1bacterial filtration effıciency (BFE),n—the effective-ness of medical face mask material in preventing the passage of aerosolized bacteria,expressed in the percentage of a known1This specification is under the jurisdiction of ASTM Committee F23on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee F23.40on Biological.Current edition approved Aug.1,2019.Published August 2019.Originally approved in st previous edition approved in 2018as F2100–11(2018).DOI:10.1520/F2100-19.2For referenced ASTM standards,visit the ASTM website,,or contact ASTM Customer Service at service@.For Annual Book of ASTM Standards volume information,refer to the standard’s Document Summary page on the ASTM website.3Available from American Society for Quality (ASQ),600N.Plankinton Ave.,Milwaukee,WI 53203,.4Available from American National Standards Institute (ANSI),25W.43rd St.,4th Floor,New York,NY 10036,.5Available from British Standards Institution (BSI),389Chiswick High Rd.,London W44AL,U.K.,.6Available from ernment Printing Office Superintendent of Documents,732N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,.Copyright ©ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT)Committee.Copyrighted material licensed to SGS SA^SGS Group. No further reproduction or distribution permitted.Printed / viewed by: [birkoff.chen@] @ 2020-02-02quantity that does not pass the medical face mask material at a given aerosolflow rate.3.1.2bodyfluid,n—any liquid produced,secreted,or ex-creted by the human body.3.1.2.1Discussion—In this specification,bodyfluids in-clude liquids potentially infected with blood-borne pathogens, including,but not limited to:blood,semen,vaginal secretions, cerebrospinalfluid,synovialfluid and peritonealfluid,amni-oticfluid,saliva in dental procedures,any bodyfluid that is visibly contaminated with blood,and all bodyfluids in situa-tions where it is difficult or impossible to differentiate between bodyfluids(see29CFR Part1910.1030).3.1.3bodyfluid simulant,n—a liquid which is used to act asa model for human bodyfluids.3.1.4differential pressure,n—the measured pressure drop across a medical face mask material.3.1.4.1Discussion—In this specification,differential pres-sure is expressed as a pressure per unit area.3.1.5flammability,n—those characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion.3.1.6medical face mask,n—an item of protective clothing designed to protect portions of the wearer’s face,including the mucous membrane areas of the wearer’s nose and mouth,from contact with blood and other bodyfluids during medical procedures.3.1.6.1Discussion—Examples of medical face masks in-clude surgical masks,procedure masks,isolation masks,laser masks,dental masks,and patient care masks.3.1.7penetration,n—in a protective clothing material or item,theflow of a chemical on a non-molecular level through closures,porous materials,seams and pinholes,or other imperfections in protective clothing.3.1.7.1Discussion—In this specification,blood or body fluids replace the term chemical and the specific penetration liquid is synthetic blood,a bodyfluid simulant.3.1.8protective clothing,n—an item of clothing that is specifically designed and constructed for the intended purpose of isolating all or part of the body from a potential hazard;or, isolating the external environment from contamination by the wearer of the clothing.3.1.8.1Discussion—The primary purpose of protective clothing is to act as a barrier for the wearer to a hazard. However,the product may also offer protection as a barrier which prevents the body from being a source of contamination.3.1.9sub-micron particulatefiltration effıciency,n—the ef-ficiency of thefilter material in capturing aerosolized particles smaller than one micron,expressed as the percentage of a known number of particles that does not pass the medical face mask material at a givenflow rate.3.1.10synthetic blood,n—a mixture of a red dye/surfactant, thickening agent,and distilled water having a surface tension and viscosity representative of blood and some other body fluids,and the color of blood.3.1.10.1Discussion—The synthetic blood in this test method does not simulate all of the characteristics of blood or bodyfluids,for example,polarity(wetting characteristics), coagulation,or content of cell matter.3.2For definitions of other protective clothing-related terms used in this test method,refer to Terminology F1494.4.Significance and Use4.1This specification covers the minimum performance requirements for materials used in the construction of medical face masks.4.2This specification provides classification of performance for a range of medical face mask materials.Medical face mask performance classes are based on the barrier performance properties of the medical face mask materials(fluid resistance, bacterialfiltration efficiency,and sub-micronfiltration effi-ciency).The list of specified properties represents industry practices for characterizing material performance,but does not include all aspects of performance that may be necessary to protect healthcare workers.Therefore,this specification does not cover medical face masks for all possible use situations. For example,the Centers for Disease Control and Prevention (CDC)specifically requires NIOSH respirators that are at least 95%efficient for tuberculosis exposure control.N OTE1—This specification does not provide specific criteria for demonstrating medical face mask protection of the patient.N OTE2—The level of protection provided by medical face masks depends on several factors not considered in this specification.Examples include facialfit and material degradation from wearer challenges (perspiration,talking,sneezing,and the length of time the medical face mask is worn).4.3Users of this specification are cautioned that improved resistance of medical face masks to penetration by synthetic blood can cause a reduction in medical face mask breathability. In general,increasing synthetic blood penetration resistance (and bacterialfiltration efficiency and sub-micron particulate filtration efficiency)results in increasing pressure drop or reduction of breathability for medical face masks of the same design.4.4This specification(or its requirements)does not evaluate medical face masks for regulatory approval as respirators.It specifically only evaluates the materials used in the construc-tion of the medical face mask and not the seal of the medical face mask against the wearer’s face or other design features that determine its effectiveness of preventing particle or liquid exposure to the wearer.If respiratory protection for the wearer is needed,a NIOSH-certified respirator meeting the require-ments of42CFR Part84should be used.4.5The selection of the appropriate medical face mask must be governed by the potential exposure hazards based on the specific areas of performance associated with class of medical face masks.General-use masks provide minimalfluid resis-tance and are suitable for situations such as in isolation settings and for certain types of patient care.Where procedures involve the generation of sub-micron particles,such as in laser or electrocautery surgery,sub-micronfiltering masks are appro-priate.Where procedures involve the probability or likely exposure to blood or bodyfluids,selectfluid-resistant medical facesmasks.5.Classification5.1Medical face mask materials covered under this speci-fication shall be designated as one or more of the following performance classes as based on the barrier performance properties of the materials used in medical face masks:Level 1barrier,Level 2barrier,and Level 3barrier.5.1.1Level 1barrier medical face mask materials are evaluated for their ability to capture sub-micron particles,resistance to penetration by synthetic blood at the minimum velocity specified in Test Method F1862,bacterial filtration efficiency,and differential pressure.5.1.2Level 2barrier medical face mask materials are evaluated for their ability to capture sub-micron particles and are evaluated for resistance to penetration by synthetic blood at the middle velocity specified in Test Method F1862,bacterial filtration efficiency,and differential pressure.5.1.3Level 3barrier medical face mask materials are evaluated for resistance to penetration by synthetic blood at the maximum velocity specified in Test Method F1862,sub-micron particulate filtration,bacterial filtration efficiency,and differential pressure.6.Requirements6.1The properties of the medical face mask material shall conform to the specifications requirements in Table 1,as tested in accordance with Section 9.N OTE 3—Medical face mask materials comprise specimens taken from manufactured medical face masks,with all layers arranged in proper order.6.2Materials used in the construction of medical face masks shall meet the requirements for Class 1,normal flammability specified in 16CFR Part 1610.7.Sampling7.1Testing shall be performed on materials taken from manufactured medical face masks.7.2An acceptable quality limit of 4%shall be used for all required testing to establish conformance of medical face masks to a specific performance class.7.3Examples of acceptable sampling plans are found in ANSI/ASQC Z1.4and ISO 2859-1.8.Number of Tests8.1A sufficient number of medical face masks shall be evaluated for each test to achieve the established acceptable quality limit or confidence level.9.Test Methods9.1Bacterial Filtration Effıciency—Determine the bacterial filtration efficiency as directed in Test Method F2101.9.2Differential Pressure—Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.N OTE 4—This test method provides a measurement of pressure per unit area of material specimen tested.9.3Sub-Micron Particulate Filtration—Determine particu-late filtration efficiency as directed in Test Method F2299.9.4Resistance to Penetration by Synthetic Blood—Determine synthetic blood penetration resistance as specified in Test Method F1862.9.5Flammability—Determine flammability as specified in 16CFR Part 1610.10.Report10.1The primary package containing the medical face masks that meet this specification shall be prominently labeled with the following information:10.1.1Manufacturer name,10.1.2Product or style name,10.1.3Product lot,and10.1.4A graphic representation indicating the performance level met in Table 1with the technical requirements of the indicated performance level.The graphic representation shall include a prominent visual indication of the performance level.11.Keywords11.1bacterial filtration efficiency;differential pressure;fluid resistance;general use;medical face masks;particle filtration efficiency;sub-micron filtrationTABLE 1Medical Face Mask Material Requirements byPerformance LevelCharacteristicLevel 1Barrier Level 2Barrier Level 3Barrier Bacterial filtration efficiency,%$95$98$98Differential pressure,mm H 2O/cm 2<5.0<6.0<6.0Sub-micron particulate filtration efficiency at 0.1micron,%$95$98$98Resistance to penetration by synthetic blood,minimum pressure in mm Hg for pass result80120160Flame spreadClass 1Class 1Class1ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned in this ers of this standard are expressly advised that determination of the validity of any such patent rights,and the risk of infringement of such rights,are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed everyfive years and if not revised,either reapproved or withdrawn.Your comments are invited either for revision of this standard or for additional standards and should be addressed to ASTM International Headquarters.Your comments will receive careful consideration at a meeting of the responsible technical committee,which you may attend.If you feel that your comments have not received a fair hearing you should make your views known to the ASTM Committee on Standards,at the address shown below.This standard is copyrighted by ASTM International,100Barr Harbor Drive,PO Box C700,West Conshohocken,PA19428-2959, United States.Individual reprints(single or multiple copies)of this standard may be obtained by contacting ASTM at the above address or at610-832-9585(phone),610-832-9555(fax),or service@(e-mail);or through the ASTM website ().Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center,222 Rosewood Drive,Danvers,MA01923,Tel:(978)646-2600;/。
产品质量检定规程 英语
产品质量检定规程英语The product quality inspection regulations areessential for ensuring that products meet the required standards and specifications. These regulations outline the procedures and criteria for inspecting the quality of products, including the methods, equipment, and personnel qualifications required for conducting inspections. They also specify the sampling plans, acceptance criteria, and documentation requirements for the inspection process.The product quality inspection regulations are designed to ensure that products are safe, reliable, and meet the expectations of consumers. They help to prevent the distribution of substandard or defective products in the market, thereby protecting the interests of both consumers and manufacturers.In addition, these regulations often incorporate international standards and best practices to ensure that products meet global quality requirements. This isespecially important for companies engaged in international trade, as adherence to these regulations can facilitate market access and enhance the competitiveness of their products in the global marketplace.Furthermore, product quality inspection regulations play a crucial role in regulatory compliance and quality management systems. By following these regulations, companies can demonstrate their commitment to quality and compliance with applicable standards, which is essentialfor building trust with customers and stakeholders.Overall, the product quality inspection regulations are an integral part of ensuring the quality and safety of products, promoting fair trade practices, and upholding consumer confidence. Adhering to these regulations is essential for companies to thrive in today's competitive and globalized marketplace.。
QC customer requirement _ 9 Nov 11
inspection only, No buyer
inspector knows failed test has been accepted and the actual condition. Without the HEB QA approval email, inspector should fail the inspection result as a follow up.
SRA required
3rd party inspection maybe required.
I
2.5
4.0
General LI & Fung inspection requirements. Products must meet All regulatory, Customs and performance requirements.
SRA
Special Notice
Remarks
A copy of Aaron Brothers Wall Frame Standard is available for inspection reference.
ACTIVE
BELL
ACTIVE
CLCL
ACTIVE
HEBG
ACTIVE
PEPL
ACTIVE
Area
USA
USA
USA
Customer Aaron Brothers
(USA)
Bealls Department Stores (USA) Caluco
HEB (USA)
USA
USA
USA USA USA USA
Peachtree (USA Importer)
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Shop Inspection Requirements for Instruments ItemsOwner: means Owner ,MC or Third Party Inspector assigned by Owner/ Purchaser: means Purchaser or Purchaser's Inspector / Vendor: means Vendor or Vendor's InspectorM: Inspection/Tests to be performed by VendorX: Required submission of Certificates/Records to Purchaser Y: Required no submission of Certificates/Records but review at Vendor shopH: Hold Point implies that relevant production activities shall not proceed until the continuation of work is permitted by Purchaser. (Notification req'd) W: Witness point implies that Purchaser intends to witness the designated inspection feature. If Purchaser decides not towitness the relevant feature, production can proceed without permission of Purchaser. (Notification req'd)S: Witness, but spot check basis. Initial operation will be witness point and subsequent operation will be witnessed at discretion of Purchaserconsidering the results of previous inspection. (Notification not req'd : Randam Inspection)R: Review inspection & test records (Notification not req'd)General Note :1) Witness/hold point by Code Inspector, when applied by Code /Local Regulation, is to comply with its requirements and to specify in Vendor's ITP.2) Type of Inspection by Purchaser may be changed according to equipment criticality and vendor QC evaluation at job stage.3) When requested in the requisition, detailed ITP shall be submitted by Vendor.4) Monitoring/Observation of Vendor shop daily routine works(i.e.Storage of materials ,Adherence to approved procedures,Testing tool calibration check,workmanship,cleanliness and etc.)shall be done by Purchaser during inspection visit.5)100% inspection which is covered by the combination of witness / spot check / record review inspection & tests listed above and vendor's original QC activity shall be confirmed by Purchaser's inspector prior to shipment.6)Unless otherwise specified in REQ., the sampling Q'ty of " S (Spot Witness Check) " shall be as follows:3 to 20䊻3Pcs(all if total 2 and less) , 21 to 50䊻5Pcs, 51 to 100䊻10Pcs,101 to 200䊻20Pcs, 201 to 300䊻30Pcs, 301 to 500䊻50PcsMinimum 25 pcs or more of the commodity shall be arranged for H/W/S inspection and test at one time inspector's visit as much as practical. 7)Final Visual Inspection/Documentation Review/Pre-Shipment Inspection may be combined within one time visit.Shop Inspection Requirements for Instruments ItemsOwner: means Owner ,MC or Third Party Inspector assigned by Owner/ Purchaser: means Purchaser or Purchaser's Inspector / Vendor: means Vendor or Vendor's InspectorM: Inspection/Tests to be performed by VendorX: Required submission of Certificates/Records to Purchaser Y: Required no submission of Certificates/Records but review at Vendor shopH: Hold Point implies that relevant production activities shall not proceed until the continuation of work is permitted by Purchaser. (Notification req'd) W: Witness point implies that Purchaser intends to witness the designated inspection feature. If Purchaser decides not towitness the relevant feature, production can proceed without permission of Purchaser. (Notification req'd)S: Witness, but spot check basis. Initial operation will be witness point and subsequent operation will be witnessed at discretion of Purchaserconsidering the results of previous inspection. (Notification not req'd : Randam Inspection)R: Review inspection & test records (Notification not req'd)General Note :1) Witness/hold point by Code Inspector, when applied by Code /Local Regulation, is to comply with its requirements and to specify in Vendor's ITP.2) Type of Inspection by Purchaser may be changed according to equipment criticality and vendor QC evaluation at job stage.3) When requested in the requisition, detailed ITP shall be submitted by Vendor.4) Monitoring/Observation of Vendor shop daily routine works(i.e.Storage of materials ,Adherence to approved procedures,Testing tool calibration check,workmanship,cleanliness and etc.)shall be done by Purchaser during inspection visit.5)100% inspection which is covered by the combination of witness / spot check / record review inspection & tests listed above and vendor's original QC activity shall be confirmed by Purchaser's inspector prior to shipment.6)Unless otherwise specified in REQ., the sampling Q'ty of " S (Spot Witness Check) " shall be as follows:3 to 20䊻3Pcs(all if total 2 and less) , 21 to 50䊻5Pcs, 51 to 100䊻10Pcs,101 to 200䊻20Pcs, 201 to 300䊻30Pcs, 301 to 500䊻50PcsMinimum 25 pcs or more of the commodity shall be arranged for H/W/S inspection and test at one time inspector's visit as much as practical. 7)Final Visual Inspection/Documentation Review/Pre-Shipment Inspection may be combined within one time visit.。