iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM D4196-05

(Test Method)

Standard Test Method for Confirming the Sterility of Membrane Filters

Standard Test Method for Confirming the Sterility of Membrane Filters

SIGNIFICANCE AND USE
This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.
SCOPE
1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.  
1.2 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.

General Information

Status
Historical
Publication Date
31-Dec-2004
ICS
11.080.99 - Other standards related to sterilization and disinfection
Technical Committee
D19 - Water
Drafting Committee
D19.08 - Membranes and Ion Exchange Materials
Current Stage
Ref Project

Relations

Replaces
ASTM D4196-82(1998) - Standard Test Method for Confirming the Sterility of Membrane Filters
Effective Date
01-Jan-2005
Replaced By
ASTM D4196-05(2011) - Standard Test Method for Confirming the Sterility of Membrane Filters
Effective Date
01-Jun-2011

Buy Standard

ASTM D4196-05 - Standard Test Method for Confirming the Sterility of Membrane FiltersASTM D4196-05 - Standard Test Method for Confirming the Sterility of Membrane Filters
PreviousNext
Standard
ASTM D4196-05 - Standard Test Method for Confirming the Sterility of Membrane Filters
English language
2 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: D4196 – 05
Standard Test Method for
1
Confirming the Sterility of Membrane Filters
This standard is issued under the fixed designation D4196; the number immediately following the designation indicates the year of
original 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. Scope Additionally, this test may be used to monitor the efficacy of
in-house sterilization procedures. Filter packages that have
1.1 This test method describes a test to confirm the sterility
obvious packaging defects should not be tested because steril-
of either manufacturer presterilized or user-sterilized analytical
ity may have been compromised.
membrane filters.
1.2 This standard does not purport to address all of the
6. Reagents and Materials
safety concerns, if any, associated with its use. It is the
6.1 Purity of Water— Unless otherwise indicated, reference
responsibility of the user of this standard to establish appro-
to water shall be understood to mean Type II reagent grade
priate safety and health practices and determine the applica-
water in accordance with Specification D1193.
bility of regulatory limitations prior to use.
6.2 Media—Use commercially available dehydrated media.
2. Referenced Documents Dissolve and sterilize by autoclaving, in accordance with the
2
manufacturer’s directions.
2.1 ASTM Standards:
6.2.1 Fluid Thioglycollate Medium (Note)—Dispense
D1129 Terminology Relating to Water
40-mL aliquots into suitable-sized vessels with screw-cap
D1193 Specification for Reagent Water
closure,providingaratioofsurfaceareatodepthofmediumso
2.2 Other Standard:
3
that no more than the upper half of the medium has initially
The United States Pharmacopeia, Current Edition (Sec-
undergone a color change indicative of oxygen uptake. When
tions on Sterilization and Sterility Testing)
ready for use, not more than the upper one tenth of the medium
3. Terminology should be pink. The medium may be restored once by heating
infree-flowingsteamuntilthepinkcolordisappears.ThepHof
3.1 Definitions—For definitions of terms used in this test
the medium, after autoclaving, should be 7.1 6 0.2.
method, refer to Terminology D1129.
NOTE 1—If stored at 2 to 5°C in sealed containers, the media may be
4. Summary of Test Method
used for 1 year provided they are tested for the growth-promoting
4.1 The membrane filters are immersed in sterile culture properties every 3 months.
media and incubated at temperatures that are suitable for
6.2.2 Soybean-Casein Digest Medium (Note)—Dispense
growth of viable bacteria, fungi, and yeasts. Growth of
40-mL aliquots into suitable vessels with screw-cap closure.
organisms is evidence that the filter has failed the test.
The pH after autoclaving should be 7.3 6 0.2.
6.2.3 Perform a sterility test on each lot of autoclaved
5. Significance and Use
medium by incubating ten representative containers of each
5.1 This test method may be employed to check the sterility
medium, for not less than 10 days, at the specified test
of commercially procured sterile membrane filters. The test
temperature.
also confirms that sterilized filters have not been contaminated.
6.2.4 Perform a growth-promotion test, as described below,
on each lot of autoclaved medium.
1
6.2.4.1 Inoculate duplicate test containers of each medium
This test method is under the jurisdiction of ASTM Committee D19 on Water
and is the direct responsibility of Subcommittee D19.08 on Membranes and Ion separately with less than 100 of each of the below listed
Exchange Materials.
microorganisms. Incubate 7 days at the temperatures listed
Current edition approved Jan. 1, 2005. Published February 2005. Originally
below:
approved in 1982. Last previous edition approved in 1998 as D4196 – 82 (1998).
DOI: 10.1520/D4196-05.
A
2 Medium Test Organisms Temperature,° C
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
B
Fluid thioglycollate Bacillus subtilis (ATCC 6633) 30 to 35
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Candida Albicans (ATCC 10231) 30 to 35
Standards volume information, refer to the standard’s Document Summary page on
B
Soybean-casein Bacillus subtilis (ATCC 6633) 20 to 25
the ASTM website.
Candida albicans (ATCC 10231) 20 to 25
3
Mack Publishing Co., Easton, PA 18042.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D4196 – 05
A
Available from the American Type Culture Collection, 12301 Parkview Drive,
8. Interpretation of Results
Rockville, MD 20852.
B
If a non-spore-forming organism is desired, use Micrococcus Luteus (ATCC 8.1 The membrane filters
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

ASTM
ASTM D4196-05(2019)(Test Method)
Standard Test Method for Confirming the Sterility of Membrane Filters

SIGNIFICANCE AND USE
5.1 This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.
SCOPE
1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.  
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.

  • Standard
    2 pages
    English language
    sale 15% off
ASTM
ASTM D4196-05(2019)(Test Method)
Standard Test Method for Confirming the Sterility of Membrane Filters

SIGNIFICANCE AND USE
5.1 This test method may be employed to check the sterility of commercially procured sterile membrane filters. The test also confirms that sterilized filters have not been contaminated. Additionally, this test may be used to monitor the efficacy of in-house sterilization procedures. Filter packages that have obvious packaging defects should not be tested because sterility may have been compromised.
SCOPE
1.1 This test method describes a test to confirm the sterility of either manufacturer presterilized or user-sterilized analytical membrane filters.  
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.

  • Standard
    2 pages
    English language
    sale 15% off
ASTM
ASTM F3321-19(Guide)
Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.  
5.3 Methods describing various techniques for extracting soil are given.  
5.4 Guidance is further given as to how to validate the method(s) for extraction.
SCOPE
1.1 This guide provides methods and considerations for extracting test soil(s) from reusable medical device(s) that occurs during simulated use validation, clinical use of the device(s) and after the device(s) have been through a cleaning process.  
1.2 This is a part of a series of ASTM guides for validating cleaning instructions. The scope of the first guide in the series is regarding selecting appropriate test soils (Guide F3208). The second in the series (Guide F3293) describes methods that are used to inoculate medical devices with simulated-use test soil(s). This third in the series describes methods for extracting test soils in order to measure residual soil remaining on medical devices after the performance of cleaning procedures.  
1.3 Units—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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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.

  • Guide
    4 pages
    English language
    sale 15% off
ASTM
ASTM E2721-16(Practice)
Standard Practice for Evaluation of Effectiveness of Decontamination Procedures for Surfaces When Challenged with Droplets Containing Human Pathogenic Viruses

SIGNIFICANCE AND USE
5.1 The efficacy of disinfection technologies can be evaluated on finished products, as well as on developmental items.  
5.2 This practice defines procedures for validation of the droplet generator, preparation of the test specimen, application of the challenge virus, enumeration of viable viruses, assessing data quality, and calculation of decontamination efficiency.  
5.3 This practice provides defined procedures for creating droplets that approximate those produced by human respiratory secretions, with particular emphasis on droplet size distribution and aerosolization media.  
5.4 Safety concerns associated with aerosolizing microbial agents are not addressed as part of this practice. Individual users should consult with their local safety authority, and a detailed biological aerosol safety plan and risk assessment should be conducted prior to using this practice. Users are encouraged to consult the manual Biosafety in Microbiological and Biomedical Laboratories5 published by the U.S. Centers for Disease Control and Prevention (CDC).  
5.5 This practice differs from Test Methods E1052 and E2197 in the presentation of virus to the surface. The aforementioned test methods use a liquid inoculum to contaminate carrier surfaces, whereas this practice presents the virus in droplets that are representative of human respiratory secretions  
5.6 This practice differs from Practice E2720, because (1) larger droplets are being formed, (2) the droplets will not be completely dried prior to application to surfaces, (3) the droplets can be applied to any surfaces, not just those that are air permeable, and (4) unique equipment is required to create droplets.
SCOPE
1.1 This practice is designed to evaluate decontamination methods (physical, chemical, self-decontaminating materials) when used on surfaces contaminated with virus-containing droplets.  
1.2 This practice defines the conditions for simulating respiratory droplets produced by humans and depositing the droplets onto surfaces.  
1.3 The practice is specific to influenza viruses but could be adapted for work with other types of respiratory viruses or surrogates.  
1.4 This practice is suitable for working with a wide variety of environmental surfaces.  
1.5 This practice does not address the performance of decontaminants against microbes expelled via blood splatter, vomit, or fecal contamination.  
1.6 This practice should be performed only by those trained in bioaerosols, microbiology, or virology, or combinations thereof.  
1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.8 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
    7 pages
    English language
    sale 15% off
  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM F1210-23(Guide)
Standard Guide for Ecological Considerations for the Use of Oil Spill Dispersants in Freshwater and Other Inland Environments, Lakes and Large Water Bodies

SIGNIFICANCE AND USE
3.1 This guide is meant to aid response teams who may use it during spill response planning and spill events.  
3.2 This guide should be adapted to site specific circumstance.
SCOPE
1.1 This guide covers the use of oil spill dispersants to assist in the control of oil spills. The guide is written with the goal of minimizing the environmental impacts of oil spills; this goal is the basis on which the recommendations are made. Aesthetic and socioeconomic factors are not considered, although these and other factors are often important in spill response.  
1.2 Spill responders have available several means to control or clean up spilled oil. Chemical dispersants should be given equal consideration with other spill countermeasures.  
1.3 This is a general guide only. Oil, as used in this guide, includes crude oils and refined petroleum products. Differences between individual dispersants or between different oil products are not considered. The dispersibility of the oil with the chosen dispersant should be evaluated.  
1.4 The guide is organized by habitat type, for example, small ponds and lakes, rivers and streams, and land. It considers the use of dispersants primarily to protect habitats from impact (or to minimize impacts).  
1.5 This guide applies only to freshwater and other inland environments. It does not consider the direct application of dispersants to subsurface waters.  
1.6 In making dispersant use decisions, appropriate government authorities should be consulted as required by law.  
1.7 This guide does not address getting regulatory approval.  
1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.9 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.  
1.10 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.

  • Guide
    3 pages
    English language
    sale 15% off
  • Guide
    3 pages
    English language
    sale 15% off
ASTM
ASTM C596-23(Test Method)
Standard Test Method for Drying Shrinkage of Mortar Containing Hydraulic Cement

SIGNIFICANCE AND USE
4.1 This test method establishes a selected set of conditions of temperature, relative humidity and rate of evaporation of the environment to which a mortar specimen of stated composition shall be subjected for a specified period of time during which its change in length is determined and designated “drying shrinkage.”  
4.2 The drying shrinkage of mortar as determined by this test method has a linear relation to the drying shrinkage of concrete made with the same cement and exposed to the same drying conditions.4 Hence this test method may be used when it is desired to develop data on the effect of a hydraulic cement on the drying shrinkage of concrete made with that cement.
SCOPE
1.1 This test method determines the change in length on drying of mortar bars containing hydraulic cement and graded standard sand.  
1.2 The values stated in SI units are to be regarded as standard. When combined standards are referenced, the selection of measurement system is at the user’s discretion subject to the requirements of the referenced 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. Warning—Fresh hydraulic cementitious mixtures are caustic and may cause chemical burns to skin and tissue upon prolonged exposure).2  
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.

  • Standard
    4 pages
    English language
    sale 15% off
  • Standard
    4 pages
    English language
    sale 15% off
ASTM
ASTM D1751-23(Specification)
Standard Specification for Preformed Expansion Joint Filler for Concrete Paving and Structural Construction (Nonextruding and Resilient Asphalt Types)

SCOPE
1.1 This specification covers preformed expansion joint filler having relatively little extrusion and substantial recovery after release from compression.  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
Note 1: Attention is called to Specifications D1752 and D994/D994M.  
1.3 The text of this standard references notes and footnotes which provide explanatory material. These notes and footnotes (excluding those in tables and figures) shall not be considered as requirements of the standard.  
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.

  • Technical specification
    2 pages
    English language
    sale 15% off
  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM B637-23(Specification)
Standard Specification for Precipitation-Hardening and Cold Worked Nickel Alloy Bars, Forgings, and Forging Stock for Moderate or High Temperature Service

ABSTRACT
This specification covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for high-temperature service. Chemical analysis shall be performed on the alloy and shall conform to the chemical composition requirement in carbon, manganese, silicon, phosphorus, sulfur, chromium, cobalt, molybdenum, columbium, tantalum, titanium, aluminum, zirconium, boron, iron, copper, and nickel. The material shall follow recommended annealing treatment, solution treatment, stabilizing treatment, and precipitation hardening treatment. Tension testing, hardness testing and stress-rupture testing shall be performed on the material and shall comply to the required tensile strength, yield strength, elongation, reduction in area, and Brinell hardness.
SCOPE
1.1 This specification2 covers hot- and cold-worked precipitation-hardenable nickel alloy rod, bar, forgings, and forging stock for moderate or high temperature service (Table 1).  
1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 become familiar with all hazards including those identified in the appropriate Safety Data Sheet (SDS) for this product/material as provided by the manufacturer, 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.

  • Technical specification
    7 pages
    English language
    sale 15% off
  • Technical specification
    7 pages
    English language
    sale 15% off
ASTM
ASTM D8139-23(Specification)
Standard Specification for Semi-Rigid, Closed-Cell Polypropylene Foam, Preformed Expansion Joint Fillers for Concrete Paving and Structural Construction

SCOPE
1.1 This specification covers preformed expansion joint fillers made from closed-cell polypropylene foam materials having suitable compressibility, recovery from compression, nonextruding, and weather-resistant characteristics.  
1.1.1 Type I, closed-cell polypropylene foam.  
1.2 These joint fillers are intended for use in concrete pavements in full-depth joints. There are several variations in size with typical thicknesses of 1/2 in. (12.7 mm), 3/4 in. (19.05 mm), and 1 in. (25.4 mm); typical widths of 31/2 in. (88.9 mm), 4 in. (101.6 mm), 5 in. (127 mm), 6 in. (152.5 mm), 7 in. (177.8 mm), 8 in. (203.2 mm), or 48 in. (1.2 m) sheet; and typical lengths of 5 ft (1.52 m) and 10 ft (3.05 m).  
1.3 The values stated in inch-pound units are to be regarded as the 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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.

  • Technical specification
    2 pages
    English language
    sale 15% off
  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM F3337-23(Guide)
Standard Guide for Taking Property and Behavior Measurements on Weathered Fractions of Oil

SIGNIFICANCE AND USE
5.1 A standard procedure is necessary to establish property changes for spilled oils or petroleum products at different oil weathering stages.  
5.2 This procedure employs standardized equipment, and test procedures.  
5.3 This procedure should be performed at the stages of weathering corresponding to the spill conditions of interest.
SCOPE
1.1 This guide summarizes methods to fractionate oil by evaporative weathering and then measure the properties and behavior of the weathered oil. The results of this guide can provide oil behavior data for input into oil spill models and response method selection.  
1.2 This guide covers general procedures for oil weathering and behavior and does not cover all possible procedures which may be applicable to this topic.  
1.3 The results obtained using this guide are intended to provide baseline data for the behavior of oil and petroleum products when spilled and input to oil spill models.  
1.4 The results obtained using this guide can be used directly to predict certain facets of oil spill behavior or as input to oil spill models.  
1.5 The accuracy of the guide depends very much on the representative nature of the oil sample used. Certain oils can have different properties depending on their chemical contents at the moment a sample is taken.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.7 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.  
1.8 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.

  • Guide
    4 pages
    English language
    sale 15% off
  • Guide
    4 pages
    English language
    sale 15% off