iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM F2450-04

(Guide)

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

SCOPE
1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore size distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and for providing reliable quality control data.
This guide 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 to determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Oct-2004
ICS
11.100 - Laboratory medicine
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Replaced By
ASTM F2450-09 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
Effective Date
01-Jun-2009
Referred By
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
01-Nov-2004
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Nov-2004
Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
01-Nov-2004
Referred By
ASTM F2791-15 - Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
Effective Date
01-Nov-2004
Referred By
ASTM F3259-17 - Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds
Effective Date
01-Nov-2004
Referred By
ASTM F2603-06(2020) - Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
Effective Date
01-Nov-2004
Referred By
ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
Effective Date
01-Nov-2004
Referred By
ASTM F2952-22 - Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold
Effective Date
01-Nov-2004
Referred By
ASTM F755-19 - Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants
Effective Date
01-Nov-2004

Buy Standard

ASTM F2450-04 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical ProductsASTM F2450-04 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
PreviousNext
Guide
ASTM F2450-04 - Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
English language
9 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:F2450–04
Standard Guide for
Assessing Microstructure of Polymeric Scaffolds for Use in
1
Tissue Engineered Medical Products
This standard is issued under the fixed designation F 2450; 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 (e) indicates an editorial change since the last revision or reapproval.
4
1. Scope 2.2 ISO Standard:
ISO 845 Cellular Plastics and Rubbers—Determination of
1.1 This guide covers an overview of test methods that may
Apparent (Bulk) Density
be used to obtain information relating to the dimensions of
pores, the pore size distribution, the degree of porosity,
3. Terminology
interconnectivity, and measures of permeability for porous
3.1 Definitions:
materials used as polymeric scaffolds in the development and
3.1.1 bioactive agent, n—any molecular component in, on,
manufacture of tissue engineered medical products (TEMPs).
or within the interstices of a device that is intended to elicit a
This information is key to optimizing the structure for a
desired tissue or cell response.
particular application, developing robust manufacturing routes,
3.1.1.1 Discussion—Growthfactorsandantibioticsaretypi-
and for providing reliable quality control data.
cal examples of bioactive agents. Device structural compo-
1.2 This guide does not purport to address all of the safety
nents or degradation byproducts that evoke limited localized
concerns, if any, associated with its use. It is the responsibility
bioactivity are not included.
of the user of this standard to establish appropriate safety and
3.1.2 blind (end)-pore, n—a pore that is in contact with an
health practices and to determine the applicability of regula-
exposed internal or external surface through a single orifice
tory limitations prior to use.
smaller than the pore’s depth.
2. Referenced Documents 3.1.3 closed cell, n—a void isolated within a solid, lacking
2
any connectivity with an external surface. Synonym: closed
2.1 ASTM Standards:
pore
D 2873 Test Method for Interior Porosity of Poly(Vinyl
3.1.4 hydrogel, n—a water-based open network of polymer
Chloride) (PVC) Resins by Mercury Intrusion Porosim-
3
chains that are cross-linked either chemically or through
etry
crystalline junctions or by specific ionic interactions.
D 4404 Test Method for Determination of Pore Volume and
3.1.5 permeability, n—a measure of fluid, particle, or gas
Pore Volume Distribution of Soil and Rock by Mercury
flow through an open pore structure.
Intrusion Porosimetry
3.1.6 polymer, n—a long chain molecule composed of
E 128 Test Method for Maximum Pore Diameter and Per-
monomers including both natural and synthetic materials, for
meability of Rigid Porous Filters for Laboratory Use
example, collagen, polycaprolactone.
E 1294 Test Method for Pore Size Characteristics of Mem-
3.1.7 pore, n—a liquid (fluid or gas) filled externally con-
brane Filters Using Automated Liquid Porosimeter
necting channel, void, or open space within an otherwise solid
F 316 Test Method for Pore Size Characteristics of Mem-
or gelatinous material (for example, textile meshes composed
brane Filters by Bubble Point and Mean Flow Pore Test
of many or single fibers (textile based scaffolds), open cell
F 2150 Guide for Characterization and Testing of Biomate-
foams, (hydrogels). Synonyms: open-pore, through-pore.
rial Scaffolds Used inTissue-Engineered Medical Products
3.1.8 porogen, n—a material used to create pores within an
inherently solid material.
3.1.8.1 Discussion—For example, a polymer dissolved in
anorganicsolventispouredoverawater-solublepowder.After
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
evaporation of the solvent, the porogen is leached out, usually
Surgical Materials and Devices and is the direct responsibility of Subcommittee
by water, to leave a porous structure. The percentage of
F04.42 on Biomaterials and Biomolecules for TEMPs.
Current edition approved Nov. 1, 2004. Published December 2004. porogenneedstobehighenoughtoensurethatalltheporesare
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
interconnected.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
4
the ASTM website. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
3
Withdrawn. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F2450–04
3.1.9 porometry, n—the determination of the distribution of 4.3 Application of the techniques
...

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 F1841-19e1(Practice)
Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

SIGNIFICANCE AND USE
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.
SCOPE
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.

  • Standard
    7 pages
    English language
    sale 15% off
ASTM
ASTM F1830-19(Practice)
Standard Practice for Collection and Preparation of Blood for Dynamic in vitro Evaluation of Hemolysis in Blood Pumps

SIGNIFICANCE AND USE
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.
SCOPE
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.

  • Standard
    3 pages
    English language
    sale 15% off
  • Standard
    3 pages
    English language
    sale 15% off
ASTM
ASTM F2450-18(Guide)
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products

SIGNIFICANCE AND USE
5.1 The ability to culture functional tissue to repair damaged or diseased tissues within the body offers a viable alternative to xenografts or heterografts. Using the patient’s own cells to produce the new tissue offers significant benefits by limiting rejection by the immune system. Typically, cells harvested from the intended recipient are cultured in vitro using a temporary housing or scaffold. The microstructure of the scaffold can be defined by the existence, type, size distribution, interconnectivity, and directionality of pores – all of which are critical for cell migration, growth, and proliferation (Appendix X1). Optimizing the design of tissue scaffolds is a complex task, given the range of available materials, different manufacturing routes, and processing conditions. All of these factors can, and will, affect the surface texture, surface chemistry, and microstructure of the resultant scaffolds. Surface texture, surface chemistry, and microstructure of the scaffolds may or may not be significant variables depending on the characteristics of a given cell type at any given time (that is, changes in cell behavior due to the number of passages, mechanical stimulation, and culture conditions).  
5.2 Tissue scaffolds are typically assessed using an overall value for scaffold porosity and a range of pore sizes, though the distribution of sizes is rarely quantified. Published mean pore sizes and distributions are usually obtained from electron microscopy images and quoted in the micrometer range. Tissue scaffolds are generally complex structures that are not easily interpreted in terms of pore shape and size, especially in three dimensions. Therefore, it is difficult to quantifiably assess the batch-to-batch variance in microstructure or to make a systematic investigation of the role that the mean pore size and pore size distribution has on influencing cell behavior based solely on electron micrographs (Tomlins et al,  (1)).4  
5.2.1 Fig. 1 gives an indication...
SCOPE
1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore size distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue-engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and providing reliable quality control data.  
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.

  • Guide
    11 pages
    English language
    sale 15% off
  • Guide
    11 pages
    English language
    sale 15% off
ASTM
ASTM F2382-18(Test Method)
Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

SIGNIFICANCE AND USE
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.
SCOPE
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.

  • Standard
    4 pages
    English language
    sale 15% off
  • Standard
    4 pages
    English language
    sale 15% off
ASTM
ASTM F2103-18(Guide)
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

SIGNIFICANCE AND USE
4.1 This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities.  
4.2 The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application.  
4.3 To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.
SCOPE
1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).  
1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.  
1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.  
1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law.  
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.

  • Guide
    9 pages
    English language
    sale 15% off
  • Guide
    9 pages
    English language
    sale 15% off
ASTM
ASTM F756-17(Practice)
Standard Practice for Assessment of Hemolytic Properties of Materials

SIGNIFICANCE AND USE
5.1 The presence of hemolytic material in contact with the blood may cause loss of, or damage to, red blood cells and may produce increased levels of free plasma hemoglobin capable of inducing toxic effects or other effects which may stress the kidneys or other organs.  
5.2 This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
SCOPE
1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood.  
1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood.  
1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood. It is recommended that both tests (extract and direct contact) be performed unless the material application or contact time justifies the exclusion of one of the tests.  
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application. Test Method E2524 provides a protocol using reduced test volumes to assess the hemolytic properties of blood-contacting nanoparticulate materials; this may include nanoparticles that become unbound from material surfaces.  
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 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.

  • Standard
    6 pages
    English language
    sale 15% off
  • Standard
    6 pages
    English language
    sale 15% off
ASTM
ASTM F2147-01(2016)(Practice)
Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens

ABSTRACT
This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity. It is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. The split adjuvant method is used when topical application is considered relevant, and the dosage form is a solid, liquid, extract, paste, or gel. The method includes four induction doses applied over a period of time to the same shaved or depilated site on guinea pigs, followed by occlusive patching. Freund's Complete Adjuvant (FCA) is injected near the dose site on a specific time, (second induction dose). Following a rest period, animals are challenged at a previously unexposed site, and the reaction evaluated at regular intervals. The closed patch method is used when topical application is relevant, but the preferred dosage form does not permit injection under the skin or intradermally, and the discomfort involved with extended occlusive patching and adjuvant use is to be avoided. It involves repeated induction doses over a period of time at the same shaved/depilated site, followed each time by occlusive wrapping. After a rest period, animals are challenged at previously untreated sites, and their reactions evaluated after a period of time.
SIGNIFICANCE AND USE
5.1 In selecting a material for human contact in medical applications, it is important to ensure that the material will not stimulate the immune system to produce an allergic reaction under relevant exposure conditions. Extractable chemicals produced by skin contact or during physiological exposures may cause allergic reactions. Therefore, this practice provides for evaluations of solid or semisolid dosage forms using material extracts or direct evaluation of the test article. The rationale for this animal model is based on the fact that the guinea pig has been shown to be an appropriate animal model for predicting human contact dermatitis. Its tractable nature, its availability from reputable suppliers, the historical database of information already acquired using this species, and the correlation of such results to data on known human allergens, all contribute to its widespread use for allergenicity studies (1-5).4  
5.2 The need for sensitization procedures other than the maximization test (Practice F720) is based on: (1) the need for a route of exposure more similar to use conditions; (2) concern over the use of adjuvant because of its recruitment of cell types to the test site which are not typically involved in immunologic reactions, and because of the discomfort this causes in the animals; (3) absence of a proper FCA-irritant control group in the traditional maximization design; and (4) the frequency of false positives often encountered with the GPMT. Both of these tests are internationally accepted (1).
SCOPE
1.1 This practice is intended to determine the potential for a substance, or material extract, to elicit contact dermal allergenicity.  
1.2 This practice is intended as an alternative to the Guinea Pig Maximization Test (GPMT), given the limitations on dosage form and tendency for false positives associated with the latter test. See Rationale and References.  
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 determine the applicability of regulatory limitations prior to use.

  • Standard
    5 pages
    English language
    sale 15% off
ASTM
ASTM E890-94(2021)(Specification)
Standard Specification for Disposable Glass Culture Tubes

ABSTRACT
This specification covers the requirements for disposable glass culture tubes for use in culturing applications. Disposable glass culture tubes shall be made of type I (borosilicate) or type II (soda-lime) glass. Tube design shall be of one-piece construction. Other requirements shall include top or open end finish requirement, bottom or closed end requirement, residual thermal stress requirement, workmanship, and tube dimensions.
SCOPE
1.1 This specification covers the requirements for disposable glass tubes suitable for general testing and culturing applications in blood banks, hematology, bacteriology, virology, and tissue culture laboratories.  
1.2 For practical purposes, the word “disposable” according to this specification and expected product performance expressed in this specification describes those disposable glass culture tubes that are to be used one time only. Any institution or individual who reuses a disposable glass culture tube must bear full responsibility for its safety and effectiveness.  
1.3 For packaging standards, choose among the following: Specifications E920 or E921 or Practice E1133.  
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
ASTM
ASTM E714-94(2021)(Specification)
Standard Specification for Disposable Glass Serological Pipets

ABSTRACT
This specification covers disposable glass serological pipets, calibrated "to deliver," used in measuring volumes of liquids. Pipets shall be straight and have one-piece construction, fabricated from borosilicate glass, Type I, Class A or B; or soda-lime glass, Type II. Any cross section of a pipet taken in a plane perpendicular to the longitudinal axis shall be circular. The accuracy and coefficient of variation of the pipets shall be tested gravimetrically.
SCOPE
1.1 This specification covers disposable glass serological pipets, calibrated “to deliver,” used in measuring volumes of liquids.  
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.

  • Technical specification
    2 pages
    English language
    sale 15% off
ASTM
ASTM E934-94(2021)(Specification)
Standard Specification for Serological Pipet, Disposable Plastic

ABSTRACT
This specification covers disposable plastic serological pipets, calibrated to deliver when measuring volumes of liquids. The pipets shall be fabricated from crystal-grade, uncolored polystyrene, or its regrind. They shall adhere to the property requirements discussed herein for design (shape, delivery tips, top end, dimensions, and outflow times), graduation and identification markings, capacity, and accuracy and coefficient of variation.
SCOPE
1.1 This specification covers disposable plastic serological pipets, calibrated “to deliver” when measuring volumes of liquids.  
1.1.1 Any institution or individual who reuses a disposable pipet must bear full responsibility for its safety and effectiveness.  
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.

  • Technical specification
    3 pages
    English language
    sale 15% off