11.080.01 (Sterilization and disinfection in gener 标准查询与下载

ASTM E1838-10 使用成人用指垫测定卫生洗手和擦手剂的病毒清除效果的标准试验方法

This in vivo procedure is designed to test the ability of hygienic handwash and handrub agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adults. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of input virus control (two), virus remaining viable after the inoculum has been allowed to dry (two), virus eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the virus-eliminating efficiency of the substance under test. No more than 100 μL of the virus suspension are required to complete one test. The results of testing with this test method may form the basis for further tests using a suitable whole-hand test protocol (for example, Test Method E2011). This test method is designed to be performed by a trained individual, who is responsible for choosing the appropriate host system for the test virus and applying the techniques necessary for propagation and maintenance of host and test virus. For a reference text, refer to Lennette et al (8). Whereas the method described here relates to testing with viruses of human origin, it can be readily adapted to work with animal pathogenic viruses as well as bacteriophages. Standard methods for working with bacteria (Test Method E2276) and fungi (Test Method E2613) are also available. Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (9). A step for the drying of fingerpads after exposure to the control or test substance, therefore, has not been included to avoid virus removal by the drying process itself. This test method is not meant for use with surgical hand scrubs or preoperative skin preps. The level of viable virus on each fingerpad after the drying of the inoculum should not be less than 104 infectious units which would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by the test substance under the conditions of this test method.1.1 Human skin is not known to carry viruses as a part of its resident microbiota. Hands transiently contaminated with viruses can, however, act as vehicles for the spread of many types of viral infections. Hand hygiene is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reductions in the virus load may be due to a combination of virus inactivation and mechanical removal of infectious virus from the skin. 1.2 This test method is designed to determine the comparative virus-eliminating effectiveness of microbicidal or non-microbicidal formulations. This test method is not meant for use with surgical hand scrubs or preoperative skin preps. Note 18212;The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2 (6). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 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 det......

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

ASTM E1327-07 利用手指甲区域评估抗菌洗手液配方的标准试验方法

The procedure should be used to test the degerming effectiveness of antimicrobial hand washing products used by health care personnel that are intended for frequent use, and that are intended to reduce the level of contamination acquired through contact with contaminated objects or people. Performance of these procedures requires the knowledge of regulations pertaining to the protection of human subjects (Ref 1).3 1.1 This test method can be used to determine the effectiveness of antimicrobial handwashing agents (including handrubs) in the reduction of transient bacterial flora with particular emphasis on the fingernail region.1.2 A knowledge of microbiological techniques is required for these procedures.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. For more specific hazard statements, see 7.5.

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

ASTM E1327-07(2012)e1 利用手指甲区域评估抗菌洗手液配方的标准试验方法

1.1 This test method can be used to determine the effectiveness of antimicrobial handwashing agents (including handrubs) in the reduction of transient bacterial flora with particular emphasis on the fingernail region. 1.2 A knowledge of microbiological techniques is required for these procedures. 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 and health practices and determine the applicability of regulatory limitations prior to use. For more specific hazard statements, see 7.5.

Standard Test Method for Evaluation of Antimicrobial Handwash Formulations by Utilizing Fingernail Regions

ASTM E1838-02 利用成人自愿者试验液体卫生洗手剂的去除病毒有效性的标准试验方法

This in vivo procedure is designed to test the ability of hygienic handwash agents to reduce levels of selected infectious viruses from experimentally contaminated fingerpads of adult volunteers. Since the two thumbpads and all eight fingerpads can be used in any given test, it allows for the incorporation of input virus control (two), amount of virus remaining after the inoculum has been allowed to dry (two), virus eliminated after treatment with a control or reference solution (two), and up to four replicates to assess the virus-eliminating efficiency of the product under test. No more than 100 μL of the virus suspension are required to complete one test. The results of testing with this test method may form the basis for confirmatory tests using a suitable whole-hand test protocol. This test method is designed to be performed by a trained individual, who is responsible for choosing the appropriate host system for the test virus and applying the techniques necessary for propagation and maintenance of host and test virus. For a reference text, refer to Schmidt and Emmons (7). Whereas, this test method relates to testing with viruses of human origin, it can be readily adapted to work with bacteria, fungi, protozoa and bacteriophages. Infectious microorganisms left on hands after washing can be reduced further by drying the washed hands with paper, cloth, or warm air (8). A step for the drying of fingerpads after exposure to the control or test solution, therefore, has not been included to avoid virus removal by the drying process itself. This test method is not meant for use with surgical hand scrubs or preoperative skin preps. The amount of virus on each fingerpad after the drying of the inoculum should not be less than 104 infectious units that would permit the detection of up to a 4 log10 reduction in the infectivity titer of the virus by a given product under the conditions of this test method.1.1 Human skin does not carry viruses as a part of its resident flora. Hands transiently contaminated with viruses, however, can act as vehicles for the spread of many types of viral infections. Hygienic hand washing is meant to reduce the load of viruses and other transient microorganisms on hands, thereby reducing the risk of disease transmission. Such reduction in the virus load may be due to a combination of virus inactivation and removal of infectious virus from the skin.1.2 Standard test methods to assess the capacity of hygienic handwash and handrub agents to reduce virus levels on hands are not presently available. This test method, therefore, has been designed to determine the comparative virus-eliminating effectiveness of germicidal or non-germicidal formulations. This test method is not meant for use with surgical hand scrubs or preoperative skin preps. Note 18212;The test method should be performed by persons with training in virology in facilities designed and equipped for work with infectious agents at biosafety level 2 (5). 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Test Method for Determining the Virus-Eliminating Effectiveness of Liquid Hygienic Handwash and Handrub Agents Using the Fingerpads of Adult Volunteers

ASTM E1173-01(2009) 评定手术前和导管插入术前或注射前皮肤处理的标准试验方法

These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting and to reduce significantly the number of organisms on intact skin immediately and, for preoperative and precatheterization preparations, to maintain reductions for an extended time.1.1 The test method is designed to measure the reduction of the resident microbial flora of the skin. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 In this test method, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses. 1.4 This standard does not purport to address all of the safety problems, 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. 1.5 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).

Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin Preparations

ASTM E1173-01e1 评定手术前和导管插入术前或注射前皮肤处理的标准试验方法

These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting and to reduce significantly the number of organisms on intact skin immediately and, for preoperative and precatheterization preparations, to maintain reductions for an extended time.1.1 The test method is designed to measure the reduction of the resident microbial flora of the skin. 1.2 A knowledge of microbiological techniques is required for these procedures. 1.3 In this test method, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses. 1.4 This standard does not purport to address all of the safety problems, 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. 1.5 Performance of this procedure requires a knowledge os regulations pertaining to the protection of human subjects (1).

Standard Test Method of a Evaluation of a Preoperative, Precatheterization, or Preinjection Skin Preparations

ASTM E1837-96(2007) 可再利用医疗设备(模拟使用试验)消毒过程功效测定的标准试验方法

1.1 This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms.1.2 This test method is designed to provide a reproducible procedure to verify the effectiveness of a previously validated disinfectant or disinfection procedure for reusable medical instruments and devices.1.3 This test method is not meant to define the effectiveness of or validation of the particular disinfection process used or its kinetics, but rather, it is devised to confirm the effectiveness of the disinfection process by simulating use situations with a particular test process using medical devices and instruments. Either manual or machine reprocessing can be tested.1.4 This test method is intended for use with reusable cleaned and previously sterilized or disinfected (high level) medical instruments and devices. Endoscopes are described in this test method as a worst-case example for contamination and sampling. The selected sterilization or disinfection processes, or both, should have been validated previously, as well as the effectiveness of rinsing for residual sterilant/disinfectant removal determined.1.5 An inoculum with high numbers of selected microorganisms is applied to both test and control, cleaned and sterilized, or disinfected medical instruments. Strains of microorganisms with a recorded resistance to disinfectants are used to contaminate the instrument sites known or suspected to be the most difficult to reprocess.1.6 It is impractical to test for recovery of survivors by immersion of some instruments, for example, endoscopes or some laproscopic instruments, in growth medium because of complexity, size, difficulty in long-term incubation, or deterious effects resulting from incubation. Elution of organisms from the inoculated surfaces, therefore, may be performed to estimate the number of recoverable organisms. Immersion can be used for smaller instruments.1.7 Control instruments are inoculated in the same manner as the test instruments and elution or immersion methods are performed to determine the number of organisms recoverable from the instrument. For channeled devices, such as endoscopes testing, the number of organisms recoverable from the instrument (inside and outside) will serve as the initial control count. It is expected that some fraction of the number of organisms inoculated will be lost in the process of inoculation/drying.1.8 A testing procedure can be performed on a complete reprocessing cycle or can be limited to just the cleaning or disinfection portions of the cycle whether reprocessing is done in a machine or manually.1.9 After the test cycle has been completed, remaining inoculated bacteria will be recovered from test instruments using the same elution procedures as for the control instruments.1.10 Efficacy of a disinfection cycle or reprocessing cycle, or any part thereof, may be determined by comparison of the number of microorganisms recovered from the control instrument (initial recoverable control count) to the recovery determined for the test instruments.1.11 A knowledge of microbiological techniques is required to conduct these procedures.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.

Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)

ASTM E1837-96(2002) 可再利用医疗设备(模拟使用试验)消毒过程功效测定的标准试验方法

This test method is designed to demonstrate and document that reusable devices and medical instruments can be disinfected using a specified technique. This test method can be used to verify claims of disinfection of recesses, hinged sites, lumina, or other difficult-to-reprocess areas of reusable medical devices and instruments. This test method also can be used to document the contribution of each element of the reprocessing cycle for reusable medical devices and instruments. The number of surviving bacteria may be assessed using swabbing and irrigation or total immersion. This test method may be used to produce quantitative or qualitative results.1.1 This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms.1.2 This test method is designed to provide a reproducible procedure to verify the effectiveness of a previously validated disinfectant or disinfection procedure for reusable medical instruments and devices.1.3 This test method is not meant to define the effectiveness of or validation of the particular disinfection process used or its kinetics, but rather, it is devised to confirm the effectiveness of the disinfection process by simulating use situations with a particular test process using medical devices and instruments. Either manual or machine reprocessing can be tested.1.4 This test method is intended for use with reusable cleaned and previously sterilized or disinfected (high level) medical instruments and devices. Endoscopes are described in this test method as a worst-case example for contamination and sampling. The selected sterilization or disinfection processes, or both, should have been validated previously, as well as the effectiveness of rinsing for residual sterilant/disinfectant removal determined.1.5 An inoculum with high numbers of selected microorganisms is applied to both test and control, cleaned and sterilized, or disinfected medical instruments. Strains of microorganisms with a recorded resistance to disinfectants are used to contaminate the instrument sites known or suspected to be the most difficult to reprocess.1.6 It is impractical to test for recovery of survivors by immersion of some instruments, for example, endoscopes or some laproscopic instruments, in growth medium because of complexity, size, difficulty in long-term incubation, or deterious effects resulting from incubation. Elution of organisms from the inoculated surfaces, therefore, may be performed to estimate the number of recoverable organisms. Immersion can be used for smaller instruments.1.7 Control instruments are inoculated in the same manner as the test instruments and elution or immersion methods are performed to determine the number of organisms recoverable from the instrument. For channeled devices, such as endoscopes testing, the number of organisms recoverable from the instrument (inside and outside) will serve as the initial control count. It is expected that some fraction of the number of organisms inoculated will be lost in the process of inoculation/drying.1.8 A testing procedure can be performed on a complete reprocessing cycle or can be limited to just the cleaning or disinfection portions of the cycle whether reprocessing is done in a machine or manually.1.9 After the test cycle has been completed, remaining inoculated bacteria will be recovered from test instruments using the same elution procedures as for the control instruments.1.10 Efficacy of a disinfection cycle or rep......

Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)

ASTM E1327-90(2000) 利用手指甲区域评估抗菌洗手液配方的标准试验方法

1.1 This test method covers the determination of ability of antimicrobial handwashing agents to give reductions of transient microbial flora (bacterial flora) when used in a hand washing procedure. 1.2 A knowledge of microbiological techniques is required for these procedures. 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 and health practices and determine the applicability of regulatory limitations prior to use. For more specific hazard statements, see Note 1.

Standard Test Method for Evaluation of Health Care Personnel Handwash Formulations by Utilizing Fingernail Regions