This specification covers two dimensionally different (short and long) disposable glass micropipets used primarily to collect whole human blood specimens for clinical analysis and testing. Short and long pipets are available as coated with heparin (Type I) or uncoated (Type II).The pipets shall be fabricated from borosilicate glass, Type I, Class B, or soda lime glass, Type II. Heparin shall be the ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin and shall meet the specified heparin potency. The physical requirements including design, dimensions, workmanship, color coding, capillarity, fluidity, lot or control number, resistance to centrifugal force, and heparin coating are specified. The following tests shall be performed: capillarity test, fluidity test, sheep plasma test, human whole blood test, resistance to centrifugal force test, and heparin content test. The physical requirements for short Caraway pipet and long Natelson pipet are illustrated as well.1.1 This specification covers two dimensionally different disposable glass micropipets used primarily to collect whole human blood specimens for clinical analysis and testing. They are available as coated with heparin or uncoated.1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

This specification covers the requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations. The pipets shall be made of common spirit bore white back tubing or clear glass with a white stripe applied to the outer surface of the tubing. The beads shall be made of glass or ceramic composition and shall be of red, clear, or white coloring. Materials shall be tested and the individual types shall conform to specified values of design, capacity, capacity markings, graduation lines, accuracy, workmanship, identification, and pigmentation.1.1 This specification covers requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

1 Scope This part of ISO 10993 gives guidance to agencies, man ufacturers, research laboratories and others for evaluating the interactions of medical devices with blood. It describes: (a) a classification of medical and dental devices that are int

定价： 728元 / 折扣价： 619 元

5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual continuous regions of protective clothing items.5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (1) .7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is approximately 0.042 ± 0.002 N/m.5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood.5.4 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurization of the test cell to 13.8 kPa [2 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and to correlate with visual penetration results that are obtained with a human factors validation (2). Some studies, however, suggest that mechanical pressures exceeding 345 kPa [50 psig] can occur during clinical use (3, 4). Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that are exerted on protective clothing garments during actual use. This test method is offered to identify those protective clothing materials that warrant further evaluation with a microbiological challenge.5.5 Since this test method uses visual observation rather than analytical measurements for determination of penetration, use this test method as a preliminary evaluation for possible penetration of blood and other body fluids. Perform subsequent testing with a microbiological challenge and analytical technique using Test Method F1671.NOTE 1: No viral resistance claims can be made based on this test method, as materials can pass the test method and fail Test Method F1671.5.6 Testing without considering degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective barrier can also be compromised during use by such effects as flexing and abrasion (5) . It is also possible that prewetting by contaminating materials such as alcohol and perspiration can also compromise the integrity of the protective barrier. If these conditions are of concern, evaluate the performance of protective clothing materials for synthetic blood penetration following an appropriate preconditioning technique representative of the expected conditions of use.5.7 While this test method involves a qualitative determination of the protective clothing material resistance to penetration by synthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure.5.7.1 If this procedure is used for quality control, perform proper statistical design and analysis of the data when more than three specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent passing or failing, or both, with a standard deviation. Data reported in this way helps to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as MIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859-1.1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing pass/fail determinations are based on visual detection of synthetic blood penetration.1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood.1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671.1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.1.6 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.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 702元 / 折扣价： 597 元 加购物车

5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions, as well as the usual continuous regions of protective clothing items.5.2 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (1-3).7 This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method is supplemented with a biologically based assay capable of detecting virus under the specified test conditions.5.3 Test Method F1670/F1670M allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670/F1670M uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials passing Test Method F1670/F1670M should then be tested against bacteriophage penetration using this test method to verify performance.5.4 This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basis.5.5 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens to the Phi-X174 Bacteriophage challenge suspension involves pressurization of the penetration cell to 13.8 kPa [2 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and correlate with visual penetration results that are obtained with a human factors validation (4). Some studies, however, suggest that mechanical pressures exceeding 345 kPa [50 psig] can occur during actual clinical use (5, 6). Therefore, it is important to understand that this test method does not simulate all the physical stresses and pressures that might be exerted on protective clothing materials during actual use.5.6 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluids, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (7). To help simulate the wetting characteristics of blood and body fluids, the surface tension of the Phi-X174 Bacteriophage challenge suspension is adjusted to approximate the lower end of this surface tension range. This is accomplished by adding surfactant to the Phi-X174 Bacteriophage nutrient broth. The resulting surface tension of the Phi-X174 Bacteriophage challenge suspension is approximately 0.042 ± 0.002 N/m.5.7 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective material could lead to a false sense of security. Additional tests should be considered that assess the impact of storage conditions and shelf life on disposable products and the impact of laundering and sterilization on reusable products. The integrity of the protective barrier may also be compromised during use by such effects as flexing and abrasion (8). Prewetting agents, such as alcohol, and contaminating agents, such as perspiration, may also compromise the integrity of the protective barrier. If these conditions are of concern, the performance of protective clothing materials should be evaluated for Phi-X174 Bacteriophage penetration following an appropriate preconditioning technique representative of the expected conditions of use.5.8 This test method involves a sensitive assay procedure for determining protective clothing material resistance to penetration by a surrogate microbe. Because of the length of time required to complete this method, it may not be suitable for use as a material or protective clothing quality control or quality assurance procedure.5.9 If this procedure is used for quality control or to support broad product claims concerning the viral-resistant properties of materials used in protective clothing, proper statistical design and analysis of larger data sets than those specified in this test method should be performed.8 Examples of acceptable sampling plans can be found in MIL-STD-105, ANSI/ASQ Z1.4, and ISO 2859-1.5.10 This test method requires a working knowledge of basic microbiological techniques (9).1.1 This test method is used to measure the resistance of materials used in protective clothing to penetration by blood-borne pathogens using a surrogate microbe under conditions of continuous liquid contact. Protective clothing material pass/fail determinations are based on the detection of viral penetration.1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid.1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications.1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis.1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. This test method does not address the design, overall construction and components, or interfaces of garments or other factors which may affect the overall protection offered by the protective clothing.1.5 The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.1.6 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.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 646元 / 折扣价： 550 元 加购物车

This specification describes the physical requirements and corresponding test methods for disposable glass blood sample capillary tubes for use in microhematocrit procedures. Covered here are two different types of capillary tubes, namely, Type I (coated with heparin), and Type II (uncoated). The tubes shall be fabricated from Type I, Class B borosilicate glass, or Type II soda lime glass. Conversely, the heparin used for coating Type I tubes shall be of ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin. The tubes shall conform to specified requirements for design, dimension, workmanship, color coding, and lot or control number. They should also pass the following tests for capillarity, fluidity, sheep plasma, positive and negative controls, human whole blood, heparin potency assay, and resistance to centrifugal force.1.1 This specification covers disposable glass blood sample capillary tubes for use in microhematocrit procedures.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

4.1 Blood and blood components are irradiated to predetermined absorbed doses to inactivate viable lymphocytes to help prevent transfusion-induced graft-versus-host disease (GVHD) in certain immunocompromised patients and those receiving related-donor products (1, 2).94.2 The assurance that blood and blood components have been properly irradiated is of crucial importance for patient health. This shall be demonstrated by means of accurate absorbed-dose measurements on the product, or in simulated product.4.3 Blood and blood components are usually irradiated using gamma radiation from 137Cs or 60Co sources, or X-radiation from X-ray units.4.4 Blood irradiation specifications include a lower limit of absorbed dose, and may include an upper limit or central target dose. For a given application, any of these values may be prescribed by regulations that have been established on the basis of available scientific data (see 2.6).4.5 For each blood irradiator, an absorbed-dose rate at a reference position within the canister is measured as part of irradiator acceptance testing using a reference-standard dosimetry system. That reference-standard measurement is used to establish operating parameters so as to deliver specified dose to blood and blood components.4.6 Absorbed-dose measurements are performed within the blood or blood-equivalent volume for determining the absorbed-dose distribution. Such measurements are often performed using simulated product (for example, polystyrene is considered blood equivalent for 137Cs photon energies).4.7 Dosimetry is part of a measurement management system that is applied to ensure that the radiation process meets predetermined specifications (see ISO/ASTM Practice 52628).4.8 Blood and blood components are usually irradiated in chilled or frozen condition. Care should be taken, therefore, to ensure that the dosimeters and radiation-sensitive indicators can be used under such temperature conditions.4.9 Proper documentation and record keeping are critical components of a radiation process. Documentation and record keeping requirements may be specified by regulatory authorities or may be given in the corporation’s quality policy.4.10 Response of most dosimeters has significant energy dependence at photon energies of less than 100 keV, so proper care must be exercised when measuring absorbed dose in that energy range.1.1 This practice outlines the irradiator installation qualification program and the dosimetric procedures to be followed during operational qualification and performance qualification of the irradiator. Procedures for the routine radiation processing of blood product (blood and blood components) are also given. If followed, these procedures will help ensure that blood product exposed to gamma radiation or X-radiation (bremsstrahlung) will receive absorbed doses with a specified range.1.2 This practice covers dosimetry for the irradiation of blood product for self-contained irradiators (free-standing irradiators) utilizing radionuclides such as 137Cs and   60Co, or X-radiation (bremsstrahlung). The absorbed dose range for blood irradiation is typically 15 Gy to 50 Gy.1.3 The photon energy range of X-radiation used for blood irradiation is typically from 40 keV to 300 keV.1.4 This practice also covers the use of radiation-sensitive indicators for the visual and qualitative indication that the product has been irradiated (see ISO/ASTM Guide 51539).1.5 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing and describes a means of achieving compliance with the requirements of ISO/ASTM Practice 52628 for dosimetry performed for blood irradiation. It is intended to be read in conjunction with ISO/ASTM Practice 52628.1.6 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.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 777元 / 折扣价： 661 元 加购物车

5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test.8 The Elbow Lean Test involves the application of synthetic blood to an ink pad, placement of sample fabric over the blood-soaked pad, placement of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and application of pressure through an adopted methodology.5.2 This test method is intended to simulate actual use conditions wherein areas of the healthcare worker's protective clothing are soaked with blood and compressed between the patient's body and that of the healthcare worker, or similarly between the healthcare worker and instruments. In both cases, unconfined blood can move away from the pressure point taking the path of least resistance rather than being contained as in Test Methods F1670/F1670M and F1671/F1671M.5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate liquid penetration resistance (1, 2) . It simulates a single insult in which the outer surfaces of a protective clothing item are compressed at a steady rate by the wearer's body against a wet surface. This steady rate of compression represents one potential use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test apparatus.5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure for protective clothing materials which do not pass Test Method F1670/F1670M.5.5 This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.5.5.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, hoods, and boots.5.5.2 The phrase ‘specimens from finished items’ encompasses seamed and other discontinuous regions, as well as the usual continuous regions of protective clothing items.5.6 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The synthetic blood solution may exhibit different wetting behavior on fabrics or films with identical structures but different chemical compositions. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (3). To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 0.042 ± 0.002 N/m.5.7 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood may not duplicate the polarity, and thus wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.5.8 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (4-6). No viral resistance claims can be made based on this test method, as materials can pass this test method and fail Test Method F1671/F1671M.5.9 Part of the protocol for exposing the protective clothing material specimens to synthetic blood involves applying mechanical pressure up to 345 kPa (50 psig). This mechanical pressure has been documented to discriminate protective clothing material performance and correlate with visual penetration results that are obtained with one type of human factors validation, the Elbow Lean Test.1 The Elbow Lean Test does not simulate all of the possible types of clinical exposure, as there is one contact with liquid under high mechanical pressure for a short duration. Some studies suggest that mechanical pressures exceeding 345 kPa (50 psig) can occur during clinical use (7, 8) .NOTE 1: The mechanical pressure tester can be adjusted to evaluate materials at higher pressures.5.10 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective clothing can also be compromised during use by such effects as flexing and abrasion (9) . It is also possible that pre-wetting by contaminants such as alcohol and perspiration can compromise the integrity of the protective clothing. Furthermore, high relative humidity may also affect the resistance of materials used in protective clothing to penetration by blood and other body fluids. If these conditions are of concern, evaluate the performance of protective clothing for synthetic blood penetration following an appropriate pretreatment technique representative of the expected conditions of use.5.11 This test method involves a quantitative determination of a protective clothing penetration resistance to synthetic blood under specific test conditions. It can also be used as a qualitative method for comparing the penetration resistance characteristics of similar materials and as a material quality control or assurance procedure.5.12 If this test method is used for quality control, perform proper statistical design and analysis of larger data sets where more than three specimens are tested. This type of analysis includes, but is not limited to, reporting the number of individual specimens tested and the average penetration pressure of specimens with a standard deviation. Data reported in this way helps establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as MIL-STD-105, ANSI/ASQC Z1.4, and ISO 2859-1.5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of commercial shipments, the purchaser and the supplier should conduct comparative tests to determine if there is a statistical bias between their laboratories. Competent statistical assistance is recommended for investigation of bias. As a minimum, the two parties should take a group of test specimens which are as homogeneous as possible and which are from a lot of the product of the type in question. The test specimens should then be randomly assigned in equal numbers to each laboratory for testing. The average results from the two laboratories should be compared using a non-parametric test for unpaired data and an acceptable probability level chosen by the two parties before testing is begun. If a bias is found, either its cause must be found and corrected or the purchaser and the supplier must agree to interpret future test results with consideration to the known bias.1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure.1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.1.4 The values in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.1.5 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.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 / 折扣价： 502 元 加购物车

CSA Preface This is the first edition of CAN/CSA-ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, which is an adoption without modification of the identicall

定价： 1092元 / 折扣价： 929 元

4.1 The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for a medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway.4.2 The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate. The results are reported as a percentage of the negative control.1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.1.2 All safety policies and practices shall be observed during the performance of this test method.1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 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.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 In vitro hemolysis test results for blood pumps may be substantially affected by donor species, sex, age, fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3,4 Therefore, standardization of proper whole blood collection and preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow an acceptable comparison of test results among hemolysis tests involving similar testing methods.1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices:1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are required.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

1 Scope Z364.1.1 This International Standard specifies requirements for haemodialysers, including those of coil, hollow fibre and parallel plate design, haemofilters and haemoconcentrators for single use for humans. Materials of construction and te

定价： 546元 / 折扣价： 465 元

6.1 The objective of this practice is to standardize the evaluation method for assessing the hemolytic effect of a blood pump used in extracorporeal circulation and/or circulatory assistance. By comparing the hemolysis results between a subject device and a comparator device through paired testing, a relative evaluation of hemolysis for the subject device can be made.1.1 This practice covers a protocol for the assessment of the hemolytic properties of continuous, intermittent, and pulsatile flow blood pumps used in circulatory assist, including extracorporeal, percutaneous, and implantable devices. An assessment is made based on the pump's effects on the erythrocytes over a certain period of time. Adopting current practices for this assessment, a 6-hour in vitro test is performed on a pump placed in a device-specific recirculating blood loop that mimics the pressure and flow conditions of the expected worst-case clinical use of the device. If the ultimate goal of the testing is to evaluate the blood damage potential of a pump for clinical use, it is suggested that paired testing between the subject blood pump and a legally marketed comparator device be conducted using the same blood pool in a matched blood test loop so that a relative hemolysis comparison can be made.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.1.3 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.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 / 折扣价： 502 元 加购物车

4.1 Significance—Dried blood represents a significant challenge to cleaning surgical instruments. The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble component of blood is fibrin built up during coagulation. These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood residue after reprocessing represent a significant threat for infection to healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean surgical instruments. To function properly, these machines must be performing at targeted mechanical efficiency and deliver the correct chemical cleaning agents at the correct temperature, at the correct dosage for the correct period of time. Manufacturers of automated washers and manufacturers of cleaning detergent need to evaluate the performance of their products utilizing a surrogate for surgical instruments soiled with blood. The results of the performance testing will be used to improve product design and for validation of the performance of their product for various regulatory requirements.4.2 Use—The regular, periodic use of the blood soil test is a systemic challenge to the functioning of an automated washer. To properly challenge the cleaning device, the test must be analogous to the dried blood soil, to the stainless steel substrate, and to the physical barriers presented by surgical instruments. These physical barriers include the box lock, or pivot joint of a hinged instrument, the serrated tips, and crevices of surgical instruments. On the test coupon, the components of blood are similar to the state of dried blood on instruments. By utilizing a grooved stainless steel coupon, the substrate is similar to that of stainless steel instruments. By mounting the soiled coupon in a plastic holder the physical barriers represented by cracks and crevices of instruments (for example, box locks) are represented. Users are provided with an interpretation guide that aids them in interpreting results that are less than optimal. For instance, failure to remove the fibrin layer of blood soil (which is water insoluble) indicates a problem with the chemical cleaning agent(s). Failure to evenly remove a hemoglobin soil indicates a mechanical failure. Failure to remove any soil indicates either a catastrophic mechanical failure, or inappropriate settings for the initial rinse stage. As a standardized challenge, the test provides a reproducible means for the washer manufacturer and the detergent manufacturer to compare new designs and formulations to those existing within their own product line as well as those of others in the market. For the purpose of submitting their instructions for use, the test provides a means to validate the performance of their product with a device that is a surrogate for the devices their products will be used to clean in the practical setting. This validation testing can be used as part of any necessary documentation for regulatory filings and records.1.1 This guide is based on a standardized test soil correlating to coagulated blood suitable for screening tests and the evaluation of the cleaning efficiency of washer-disinfectors used for reprocessing of surgical instruments. This guide strictly deals with cleaning and does not describe any methods that are related to disinfection. See Referenced Documents D5343, D4008, D4265, D2960, and D3050 in Section 2 for additional information.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 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.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration that is useful in establishing claims for penetration resistance performance of medical face masks and ranking their performance. However, this test method does not define acceptable levels of penetration resistance because this determination must be made by each responsible user organization based on its own specific application and conditions. Therefore, when using this test method to make claims for the performance of medical face masks, the specific conditions under which testing is conducted must be described.5.2 Medical face masks are intended to resist liquid penetration from the splatter or splashing of blood, body fluids, and other potentially infectious materials. Many factors affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials and the design of the mask itself. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m.7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is 0.042 ± 0.002 N/m.5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood. The synthetic blood will not always duplicate the polarity, and thus the wetting behavior and subsequent penetration, of real blood and other body fluids through protective clothing materials.5.4 During a medical procedure, a blood vessel is occasionally punctured resulting in a high velocity stream of blood impacting a protective medical face mask. The impact velocity depends on several factors, the most important being the blood pressure of the patient. Other factors include the size of the puncture and distance from the puncture. Because the pressure, and thus velocity drops quickly with large punctures, large punctures were not used to model the range of blood splatter velocities considered in this test. Furthermore, this test method is based on the assumption that the medical face mask will be in close proximity (within 300 mm or 12 in.) to the puncture area. The use of this test method is, therefore, based on selecting an appropriate blood pressure, finding the corresponding stream or impact velocity, and determining the valve time to create that stream velocity as shown in Appendix X1.5.4.1 The mean human blood pressure generally varies over a range of about 10.7 to 16.0 kPa (80 to 120 mmHg).8 In this test method, medical face masks are tested at stream velocities corresponding to 10.7 kPa, 16.0 kPa, and 21.3 kPa (80 mmHg, 120 mmHg, and 160 mmHg).5.5 This test method permits the use of other non-standard test pressures, stream velocities, fluid volumes, and specimen orientations for evaluating medical face mask penetration resistance consistent with specific applications.5.6 This test method differs from Test Method F1670/F1670M by dispensing a stream of 2 mL of synthetic blood against the target area of a complete medical mask specimen, whereas Test Method F1670/F1670M involves the continuous contact of a specimen of protective clothing with synthetic blood over the period of an hour. One minute of the exposure in Test Method F1670/F1670M is at hydrostatic pressure of 13.8 kPa [2.0 psig]. Test Method F1670/F1670M is used for preliminary evaluation of protective clothing penetration resistance to synthetic blood in conjunction with Test Method F1671/F1671M that uses a microbiological challenge. Both procedures are intended for assessment of protective clothing which has the potential to contact blood or other body fluids for extended periods of time, and under pressure.5.7 Users of this test method must realize that certain tradeoffs exist between improved resistance of medical face masks to penetration by synthetic blood and in pressure drop across mask materials as an indicator of medical face mask breathability. In general, increasing synthetic blood penetration resistance for medical face masks results in increasing pressure drop or reduced breathability for medical face masks of the same design and fit of the individual wearer.5.8 This test method evaluates medical face masks as an item of protective clothing and does not evaluate medical face masks as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator must be used. This test method is useful to evaluate the resistance of a respirator to penetration by synthetic blood, if warranted.5.9 This test method involves the preconditioning of specimen medical face masks in a relatively high humidity environment (85 ± 5 % relative humidity at 21 ± 5 °C [70 ± 10 °F]) to simulate the conditions of use when the wearer creates high humidity conditions by breathing through the mask. This preconditioning does not account for saturation of the interior medical face mask layer. However, additional pretreatment techniques in conjunction with this test method as described in 5.10 are permitted. Professional healthcare providers recommend that medical face masks be replaced when saturation occurs from breathing or from contact with other liquids.5.10 Testing prior to degradation by physical, chemical, and thermal stresses which could negatively impact the performance of the protective barrier, could lead to a false sense of security. Consider tests which assess the impact of storage conditions and shelf life for disposable products, and the effects of laundering and sterilization for reusable products. The integrity of the protective clothing is occasionally compromised during use by such effects as flexing and abrasion.9 It is also possible that pre-wetting by contaminants such as alcohol and perspiration also compromises the integrity of the protective clothing. If these conditions are of concern, evaluate the performance of protective clothing for synthetic blood penetration following an appropriate pretreatment technique representative of the expected conditions of use.5.11 While this test method involves a qualitative determination of the medical face mask resistance to penetration by synthetic blood under specific test conditions, it is possible to use this test method as a material quality control or assurance procedure.5.12 If this procedure is used for quality control, perform proper statistical design and analysis of larger data sets when more than the required specimens are tested. This type of analysis includes, but is not limited to, the number of individual specimens tested, the average percent passing or failing, or both, with a standard deviation. Data reported in this way help to establish confidence limits concerning product performance. Examples of acceptable sampling plans are found in references such as ANSI/ASQC Z1.4 and ISO 2859-1.5.13 In the case of a dispute arising from differences in reported results when using this test method for acceptance testing of commercial shipments, conduct comparative tests between the purchaser and supplier to determine if there is a statistical bias between their laboratories. Competent statistical assistance is recommended for investigation of bias. At minimum, take a group of test specimens which are as homogeneous as possible and which are from a lot of the product of the type in question. Randomly assign test specimens in equal numbers to each laboratory for testing. Compare the average results from the two laboratories using a non-parametric test for unpaired data and an acceptable probability level chosen by the two parties before testing is begun. If a bias is found, either its cause must be found and corrected or the purchaser and the supplier must agree to interpret future test results with consideration to the known bias.1.1 This test method is used to evaluate the resistance of medical face masks to penetration by the impact of a small volume (~2 mL) of a high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration.1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for face exposure and assess the appropriateness of this test method for their specific application.1.3 This test method primarily addresses the performance of materials or certain material constructions used in medical face masks. This test method does not address the performance of the medical face mask’s design, construction, or interfaces or other factors with the potential to affect the overall protection offered by the medical face mask and its operation (such as filtration efficiency and pressure drop). Procedures for measuring these properties are contained in Test Method F2101 and MIL-M-36954C.1.4 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask. This test method evaluates medical face masks as an item of protective clothing. This test method does not evaluate the performance of medical face masks for airborne exposure pathways or in the prevention of the penetration of aerosolized body fluids deposited on the medical face mask.1.5 The values stated in SI units or inch-pound units are to be regarded separately as standard. The pressure values stated in each system are not exact equivalents. However, as the corresponding velocities are within 1 % of each other, (see X1.4.2), reporting of the results in either units is permitted.1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 843元 / 折扣价： 717 元 加购物车