iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
ASTM

ASTM D8367-21

(Practice)

Standard Practice for Making a Laboratory Pavement Marking Sample Using a Pavement Marking and Drop-on Particles

Standard Practice for Making a Laboratory Pavement Marking Sample Using a Pavement Marking and Drop-on Particles

SIGNIFICANCE AND USE
5.1 The method described in this practice provides a procedure to rapidly generate pavement marking samples in the laboratory, suitable for the testing of applied pavement marking properties.  
5.2 This practice is intended to provide uniform laboratory pavement marking samples that reduce the variability associated with obtaining pavement marking samples in the field.  
5.3 This practice is particularly useful for directly comparing applied pavement marking properties as impacted by variations in materials, film thickness, and drop-on particle application rates for quality control or development purposes.  
5.4 This practice can be used in evaluating pavement marking materials formulated and produced in the laboratory and for drop-on particles specifically made and prepared in the laboratory. It can also be used for testing materials that are already manufactured and either stored as work-in-process or placed in its final packaging. When testing manufactured materials in the finished goods state, it is extremely important that a representative sample of the pavement marking material and the drop-on particles are obtained for use, in order to draw the proper conclusions from any testing done on pavement marking samples made from these materials. For proper sampling of thermoplastic pavement markings in a finished good state, it is recommended to follow Practices D7307 and D7308. For proper sampling of liquid pavement marking with both single and multicomponent materials, it is recommended to follow Practice D8008.
SCOPE
1.1 This practice covers a procedure and apparatus for producing a representative laboratory pavement marking sample by applying a pavement marking material onto a suitable substrate, followed immediately with an application of drop-on particles consisting of retroreflective optics or other functional particles such as skid resistance particles suitable for laboratory testing or display. Examples of pavement marking materials appropriate for this practice would include waterborne traffic paint, solvent borne traffic paint, and plural component pavement markings such as epoxy, modified epoxy, polyurea, methyl methacrylate, and thermoplastic pavement markings. Plural component materials with extremely fast gel times might not be appropriate for this practice because the material gels too quickly to allow proper embedment of the drop-on particles.  
1.2 The finished sample will consist of a pavement marking material applied in a liquid state to a sample substrate at the prescribed film thickness, with drop-on particles applied at the prescribed drop rate and embedment level on the surface of the pavement marking material, and then properly cured. The drop-on particles may consist of retroreflective optics such as glass beads or composite optics, or non-retroreflective particles such as skid resistant particles, or several of these items in combination.  
1.3 The values stated in inch-pound units are to be regarded as the standard except where noted in the practice. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.

General Information

Status
Published
Publication Date
31-Oct-2021
ICS
11.100.99 - Other standards related to laboratory medicine
Technical Committee
D01 - Paint and Related Coatings, Materials, and Applications
Drafting Committee
D01.44 - Traffic Coatings
Current Stage
Ref Project

Relations

Refers
ASTM D4414-95(2020) - Standard Practice for Measurement of Wet Film Thickness by Notch Gages
Effective Date
01-Jun-2020

Buy Standard

ASTM D8367-21 - Standard Practice for Making a Laboratory Pavement Marking Sample Using a Pavement Marking and Drop-on ParticlesASTM D8367-21 - Standard Practice for Making a Laboratory Pavement Marking Sample Using a Pavement Marking and Drop-on Particles
PreviousNext
Standard
ASTM D8367-21 - Standard Practice for Making a Laboratory Pavement Marking Sample Using a Pavement Marking and Drop-on Particles
English language
15 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)

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.
Designation: D8367 − 21
Standard Practice for
Making a Laboratory Pavement Marking Sample Using a
1
Pavement Marking and Drop-on Particles
This standard is issued under the fixed designation D8367; 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 1.5 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This practice covers a procedure and apparatus for
ization established in the Decision on Principles for the
producing a representative laboratory pavement marking
Development of International Standards, Guides and Recom-
sample by applying a pavement marking material onto a
mendations issued by the World Trade Organization Technical
suitable substrate, followed immediately with an application of
Barriers to Trade (TBT) Committee.
drop-on particles consisting of retroreflective optics or other
functionalparticlessuchasskidresistanceparticlessuitablefor
2. Referenced Documents
laboratory testing or display. Examples of pavement marking
2
2.1 ASTM Standards:
materials appropriate for this practice would include water-
D823 Practices for Producing Films of Uniform Thickness
borne traffic paint, solvent borne traffic paint, and plural
of Paint, Coatings and Related Products on Test Panels
componentpavementmarkingssuchasepoxy,modifiedepoxy,
D2205 Guide for Selection of Tests for Traffic Paints
polyurea, methyl methacrylate, and thermoplastic pavement
D4060 Test Method for Abrasion Resistance of Organic
markings. Plural component materials with extremely fast gel
Coatings by the Taber Abraser
times might not be appropriate for this practice because the
D4414 Practice for Measurement of Wet Film Thickness by
material gels too quickly to allow proper embedment of the
Notch Gages
drop-on particles.
D6628 Specification for Color of Pavement Marking Mate-
1.2 The finished sample will consist of a pavement marking
rials
material applied in a liquid state to a sample substrate at the
D7307 Practice for Sampling of Thermoplastic Pavement
prescribed film thickness, with drop-on particles applied at the
Marking Materials
prescribed drop rate and embedment level on the surface of the
D7308 Practice for Sample Preparation of Thermoplastic
pavement marking material, and then properly cured. The
Pavement Marking Materials
drop-on particles may consist of retroreflective optics such as
D8008 Practice for Representative Field Sampling of Traffic
glass beads or composite optics, or non-retroreflective particles
Paints
such as skid resistant particles, or several of these items in
E303 Test Method for Measuring Surface Frictional Proper-
combination.
ties Using the British Pendulum Tester
E1349 Test Method for Reflectance Factor and Color by
1.3 The values stated in inch-pound units are to be regarded
as the standard except where noted in the practice. The values Spectrophotometry Using Bidirectional (45°:0° or 0°:45°)
Geometry
given in parentheses are mathematical conversions to SI units
that are provided for information only and are not considered E1710 Test Method for Measurement of Retroreflective
Pavement Marking Materials with CEN-Prescribed Ge-
standard.
ometry Using a Portable Retroreflectometer
1.4 This standard does not purport to address all of the
E2177 Test Method for Measuring the Coefficient of Ret-
safety concerns, if any, associated with its use. It is the
roreflected Luminance (R ) of Pavement Markings using
L
responsibility of the user of this standard to establish appro-
the Bucket Method in a Condition of Wet Recovery
priate safety, health, and environmental practices and deter-
E2302 Test Method for Measurement of the Luminance
mine the applicability of regulatory limitations prior to use.
Coefficient Under Diffuse Illumination of Pavement
Marking Materials Using a Portable Reflectometer
1
This practice is under the jurisdiction of ASTM Committee D01 on Paint and
2
Related Coatings, Materials, and Applications and is the direct responsibility of For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Subcommittee D01.44 on Traffic Coatings. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Nov. 1, 2021. Published December 2021. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/D8367-21. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Consho
...

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 F3352/F3352M-23b(Specification)
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

SCOPE
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.  
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.  
1.3 This specification does not address protective clothing used for surgical applications, such as surgical gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
1.4 Units—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.  
1.5 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.

  • Technical specification
    11 pages
    English language
    sale 15% off
  • Technical specification
    11 pages
    English language
    sale 15% off
ASTM
ASTM E1302-23(Guide)
Standard Guide for Acute Animal Toxicity Testing of Water-Miscible Metalworking Fluids

SIGNIFICANCE AND USE
4.1 Application of this guide will provide information on the acute toxicity of water-miscible metalworking fluids and will assist the user in evaluating the potential health hazards of the fluid and developing appropriate work practices. A water-miscible metalworking fluid is a concentrate designed to be diluted in water for use.  
4.2 Water-miscible metalworking fluids are complex chemical mixtures. The United States Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (see A1.8) outlines procedures for the hazard determination of mixtures and states that if a mixture has not been tested as a whole, then the mixture shall be assumed to present the same hazards as do the components that comprise 1 % (by weight or volume) or greater of the mixture, except that the mixture shall be assumed to present a carcinogenic hazard if it contains a component in concentrations of 0.1 % or greater, which is considered to be a carcinogen (as defined in OSHA Standard 29 CFR 1910.1200). The determination of when to test a mixture as a whole and which toxicity tests are appropriate for the product must be made by a health professional qualified in evaluating toxicological data.  
4.3 Acute toxicology testing of water-miscible metalworking fluids consists of several individual tests including acute oral, dermal, or inhalation toxicity, eye irritation, skin irritation or corrosion, or both, skin sensitization, and sensory irritation. Certain protocols for acute oral, dermal, and inhalation toxicity tests are limit tests; further multi-dose testing (for example, Test Method E1103) should take place if mortality is noted on any of these tests. The referenced protocols specify the species and number of animals required. Selection of tests conducted should be designed to minimize the number of animals used.  
4.3.1 Acute Oral Toxicity—Acute oral toxicity tests (see A1.1) provide information on health hazards likely to arise from short-term exposure by the ...
SCOPE
1.1 This guide defines acute animal toxicity tests and sets forth the references for procedures to assess the acute toxicity of water-miscible metalworking fluids as manufactured.  
1.2 Although water-miscible metalworking fluids are typically used at high dilution, dilution rates vary widely. Additionally, there is potential for exposure to the metalworking fluid as manufactured.  
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
    5 pages
    English language
    sale 15% off
  • Guide
    5 pages
    English language
    sale 15% off
ASTM
ASTM F2808-23(Test Method)
Standard Test Method for Performing Behind-the-Knee (BTK) Test for Evaluating Skin Irritation Response to Products and Materials That Come Into Repeated or Extended Contact with Skin

SIGNIFICANCE AND USE
5.1 This test method is intended to assess a combination of inherent chemical irritation and mechanical irritation for products and materials expected to come into contact with the skin. It is a comparative approach whereby the potential irritation of a test material is compared to that of a reference material similar in form and composition. The reference material should have a known safety and irritation profile.
SCOPE
1.1 The behind-the-knee (BTK) method, using the popliteal fossa of human volunteers as a test site, simultaneously evaluates the inherent chemical irritation and the potential for mechanical irritation of substrates and products that are designed to come into repeated or extended close contact with the skin (see validation references (1-7)).2 This is a bilateral test comparing a test material to a reference material with a known safety profile.  
1.2 This test method shall be used by qualified health care professionals experienced in good clinical practice (GCP) procedures.  
1.3 This test method can be performed using human subjects on either intact or compromised skin. Testing should be performed on intact skin for test substrates or products expected to have contact with normal, intact skin, or for direct comparison to products with a known skin irritation profile. Testing can be performed on compromised skin for test substrates or products that may commonly come into contact with damaged skin (for example, skin with diaper rash, or chapped skin) or skin that is expected to be hydrated.  
1.4 Visual scoring of erythema and dryness is performed by a trained skin grader on a predefined scale.  
1.5 Prior to use in this test, materials shall undergo overall favorable biocompatibility testing consistent with the approach outlined in protocol Practice F748 or ISO 10993-1:2009. As a part of this series of testing, irritation per Practice F719 or ISO 10993-10 shall be conducted.  
1.6 The values stated in inch-pound 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.

  • Standard
    24 pages
    English language
    sale 15% off
  • Standard
    24 pages
    English language
    sale 15% off
ASTM
ASTM F3089-23(Guide)
Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions

SIGNIFICANCE AND USE
4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.  
4.2 This guide can be used by the following types of users:  
4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.  
4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.  
4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.  
4.3 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound an...
SCOPE
1.1 This guide is intended to provide characteristics, properties, test methods, and standardization approaches for evaluation and identification of specific polymerizable collagen formulations and collagen polymeric materials produced with these formulations.  
1.2 This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.  
1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.  
1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produce...

  • Guide
    20 pages
    English language
    sale 15% off
  • Guide
    20 pages
    English language
    sale 15% off
ASTM
ASTM F2952-22(Guide)
Standard Guide for Determining the Mean Darcy Permeability Coefficient for a Porous Tissue Scaffold

SIGNIFICANCE AND USE
4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.  
4.2 The technique is not sensitive to the presence of closed or blind-end pores (Fig. 1).
FIG. 1 Schematic of the Different Pores Types Found in Tissue Scaffolds. Fluid Flow Through the Structure is via the Open Pores  
4.3 Values of the permeability coefficient can be used to compare the consistency of manufactured samples or to determine what the effect of changing one or more manufacturing settings has on permeability. They can also be used to assess the homogeneity and anisotropy of tissue scaffolds. Variability in the permeability coefficient can be also be indicative of:  
4.3.1 Internal damage within the sample, for example, cracking or permanent deformation.  
4.3.2 The presence of large voids, including trapped air bubbles, within the structure.  
4.3.3 Surface effects such as a skin formed during manufacture.  
4.3.4 Variable sample geometry.  
4.4 This test method is based on the assumption that the flow rate through a given sample subjected to an applied pressure gradient is constant with time.
Note 1: If a steady-state flow condition isn’t reached, then this could be due to structural damage (that is, crack formation or the porous structure deformed as a result of the force being placed upon it by the fluid flowing through it). Sample deformation in the form of stretching (bowing) can also occur for less resilient structures as a result of high fluid flow rates. This topic is discussed in more detail in Section 7.  
4.5 Care should be taken to ensure that hydrophobic materials are fully wetted out when using water or other aqueous-based liquids as permeants.  
4.6 Conventionally, the p...
SCOPE
1.1 This guide describes test methods suitable for determining the mean Darcy permeability coefficient for a porous tissue scaffold, which is a measure of the rate at which a fluid, typically air or water, flows through it in response to an applied pressure gradient. This information can be used to optimize the structure of tissue scaffolds, to develop a consistent manufacturing process, and for quality assurance purposes.  
1.2 The method is generally nondestructive and non-contaminating.  
1.3 The method is not suitable for structures that are easily deformed or damaged. Some experimentation is usually required to assess the suitability of permeability testing for a particular material/structure and to optimize the experimental conditions.  
1.4 Measures of permeability should not be considered as definitive metrics of the structure of porous tissue scaffolds and should complement measures obtained by other investigative techniques, for example, scanning electron microscopy, gas flow porometry, and micro-computer X-ray tomography (Guides F2450, F2603, and F3259).  
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.

  • Guide
    7 pages
    English language
    sale 15% off
  • Guide
    7 pages
    English language
    sale 15% off
ASTM
ASTM F3088-22(Practice)
Standard Practice for Use of a Centrifugation Method to Quantify/Study Cell-Material Adhesive Interactions

SIGNIFICANCE AND USE
4.1 This practice describes a cell adhesion method that can be used to provide a detachment percent at a given RCF for cells that have adhered to a substrate, typically for a short time. The information generated by this practice can be used to obtain a semi-quantitative measurement of the adhesion of cells to either an uncoated or pre-coated substrate, when compared to a reference (adherent) cell type on the same substrate. As described in Reyes and Garcia (2003), it is recommended that the 50 % point be used for either ligand concentration or RCF for the most robust measurement of adhesion strength. The adhesion may vary due to changes in the phenotype of the cells or as a result of the specific properties of the surface. The substrate may include tissue culture-treated polystyrene, biomaterials, or bioactive surfaces. If the substrate is a hydrogel, care must be taken to avoid cohesive failure in the hydrogel (that is, detached cells have pulled away fragments of gel). The coating may consist of (but is not limited to) the following: natural or synthetic biomaterials, hydrogels, components of extracellular matrix (ECM), ligands, adhesion or bioactive molecules, genes, or gene products. Cell concentration is also critical, as use of too high a concentration of cells may result in cells detaching as a sheet, rather than as individual cells. This centrifugation approach, once validated, may be applicable for quality control (QC) and product development. However, until the method is correlated to other measures of cell attachment, the current method should be run in parallel with other known measures of cell adhesion.  
4.2 This practice does not cover methods to quantitate changes in gene expression, or changes in biomarkers, as identified by immunostaining. This practice additionally does not cover quantitative image analysis techniques. In some cases, the change in adhesive properties may reflect on the degree of differentiation or de-differentiation of the cells...
SCOPE
1.1 This practice covers a centrifugation cell adhesion assay that can be used to detect changes in adhesive characteristics of cells with passage or treatments. This approach measures the force required to detach cells from a substrate. Adhesion, among many variables, may vary due to changes in the phenotype of the cells.  
1.2 This practice does not cover methods to verify the uniformity of coating of surfaces, nor does it cover methods for characterizing surfaces.  
1.3 The cells may include adult, progenitor, or stem cells from any species. The types of cells may include chondrocytes, fibroblasts, osteoblast, islet cells, or other relevant adherent cell types.  
1.4 This practice does not cover methods for isolating or harvesting of cells. This practice does not cover methods to quantitate changes in gene expression, or changes in biomarker type or concentration, as identified by immunostaining. Nor does this practice cover quantitative image analysis techniques.  
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.

  • Standard
    8 pages
    English language
    sale 15% off
  • Standard
    8 pages
    English language
    sale 15% off
ASTM
ASTM E1092-91(2022)(Specification)
Standard Specification for Glass Micro Folin Pipet, Disposable

ABSTRACT
This specification covers the classification, physical requirements, and testing of disposable glass micro Folin pipets suitable for use in micro techniques for the estimation of blood sugar by the Folin method. The pipets shall be made of Type 1, Class B borosilicate glass, or Type 2 soda lime glass. The physical properties to which the pipets shall adhere are design, dimensions, graduation lines, pipet nomenclature, color coding, marking permanency, and lot control. The pipets shall also be tested for capacity accuracy and coefficient of variation, and marking permanency.
SCOPE
1.1 This specification covers a glass disposable micro Folin pipet suitable for use in micro techniques for estimation of blood sugar by the Folin method.  
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 The following precautionary statement pertains only to the test method portion, Section 8, of this specification.  This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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
    3 pages
    English language
    sale 15% off
ASTM
ASTM F2884-21(Guide)
Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion

SIGNIFICANCE AND USE
4.1 This guide is aimed at providing a range of in vivo models to aid in pre-clinical research and development of tissue-engineered medical products (TEMPs) intended for the clinical repair or regeneration of bone in the spine.  
4.2 This guide includes a description of the animal models, surgical considerations, and tissue processing as well as the qualitative and quantitative analysis of tissue specimens.  
4.3 The user is encouraged to utilize appropriate ASTM and other guidelines to conduct cytotoxicity and biocompatibility tests on materials, TEMPs, or both, prior to assessment of the in vivo models described herein.  
4.4 It is recommended that safety testing be in accordance with the provisions of the FDA Good Laboratory Practices Regulations 21 CFR 58.  
4.5 Safety and effectiveness studies to support regulatory submissions (for example, Investigational Device Exemption (IDE), Premarket Approval (PMA), 510K, Investigational New Drug (IND), or Biologics License Application (BLA) submissions in the U.S.) should conform to appropriate guidelines of the regulatory bodies for development of medical devices, biologics, or drugs.  
4.6 Animal model outcomes are not necessarily predictive of human results and should, therefore, be interpreted cautiously with respect to potential applicability to human conditions.
SCOPE
1.1 This guide covers general guidelines for the pre-clinical in vivo assessment of tissue-engineered medical products (TEMPs) intended to repair or regenerate bone in an interbody and/or posterolateral spinal environment. TEMPs included in this guide may be composed of, but are not limited to, natural or synthetic biomaterials or composites thereof, and may contain cells or biologically active agents such as growth factors, synthetic peptides, plasmids, or cDNA. The models described in this document represent a stringent test of a material’s ability to induce and/or augment bone growth in the spinal environment.  
1.2 While clinically TEMPs may be combined with hardware for initial stabilization or other purposes, the focus of this guide is on the appropriateness of the animal model chosen and evaluation of the TEMP-induced repair and as such does not focus on issues of components or constructs.  
1.3 Guidelines include a description and rationale of various animal models for the in vivo assessment of the TEMP. The animal models utilize a range of species including rat (murine), rabbit (lapine), dog (canine), goat (caprine), pig (porcine), sheep (ovine), and non-human primate (primates). Outcome measures include in vivo assessments based on radiographic, histologic, and CT imaging as well as subsequent in vitro assessments of the repair, including histologic analyses and mechanical testing. All methods are described briefly and referenced. The user should refer to specific test methods for additional detail.  
1.4 This guide is not intended to include the testing of raw materials, preparation of biomaterials, sterilization, or packaging of the product. ASTM standards for these steps are available in Referenced Documents (Section 2).  
1.5 The use of any of the methods included in this guide may not produce a result that is consistent with clinical performance in one or more specific applications.  
1.6 Other pre-clinical methods may also be appropriate, and this guide is not meant to exclude such methods. The material must be suitable for its intended purpose. Additional biological testing in this regard would be required.  
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 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.  
1.9 This international standard was developed in accordance with internationally recognized prin...

  • Guide
    47 pages
    English language
    sale 15% off
ASTM
ASTM F2211-13(2021)(Classification)
Standard Classification for Tissue-Engineered Medical Products (TEMPs)

SIGNIFICANCE AND USE
4.1 This classification outlines aspects of TEMPs which includes their individual components.  
4.2 The categories outlined in this classification are intended to list, identify, and group the areas pertinent to tissue-engineered medical products. This classification will be used by the Tissue-Engineered Medical Products subcommittees for the organization of the development of standards for the field of tissue engineering, TEMPs, and protocols for their use. The development of products from the new tissue engineering technologies necessitates creation and implementation of new standards (1).5  
4.3 Since interactions may occur among the components used in TEMPs, new standard descriptions, test methods, and practices are needed to aid the evaluation of these interactions. The degree of overall risk for any given TEMP is reflected by the number and types of tests required to demonstrate product safety and efficacy.
SCOPE
1.1 This classification outlines the aspects of tissue-engineered medical products that will be developed as standards. This classification excludes traditional transplantation of organs and tissues as well as transplantation of living cells alone as cellular therapies.  
1.2 This classification does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.  
1.3 This standard does not purport to address specific components covered in other standards. Any safety areas associated with the medical product's use will not be addressed in this standard. 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
    8 pages
    English language
    sale 15% off
ASTM
ASTM F2529-13(2021)(Guide)
Standard Guide for  in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)

SIGNIFICANCE AND USE
4.1 This guide covers animal implantation methods and analysis of the explanted DBM-containing material to determine whether a material or substance possesses osteoinductive potential, as defined by its ability to cause bone to form in vivo at a site that would otherwise not support bone formation, that is, heterotopically in a skeletal muscle implant site. For in vitro evaluation see Test Method F2131 for in vitro assessment of rhBMP 2.  
4.2 The test methods described here may be suitable for defining product specifications, cGMP lot release testing, research evaluation, regulatory submission, and so forth, but a positive outcome should not be presumed to indicate that the product will be osteoinductive in a human clinical application. At present, the only direct assays to assess new bone formation are in vivo, since the property of bone conduction or induction can only be assessed in a heterotopic or orthotopic site in a living animal. When these products are implanted in an orthotopic site, osteogenic factors already present at the implantation site may contribute to and enhance bone formation in conjunction with the osteoconductive nature of the product. Thus, orthotopic implantation of products may result in bone formation by acting on existing bone-forming cells and not by causing mesenchymal stem cells to become osteochondroprogenitor cells. In contrast, when these products are implanted in a heterotopic site, no native osteogenic factors are present to contribute to or enhance bone formation. Thus, heterotopic implantation of products will only result in new bone formation by causing mesenchymal stem cells to become osteochondroprogenitor cells. In vitro assays have been described and some believe they may correlate to the results obtained from in vivo assays. However such in vitro assays measure only some of the biochemical marker(s) associated with in vivo bone formation and are therefore only indirect assays for osteoinductive activity or the capacity t...
SCOPE
1.1 This guide covers general guidelines to evaluate the effectiveness of DBM-containing products intended to cause and/or promote bone formation when implanted or injected in vivo. This guide is applicable to products that may be composed of one or more of the following components: natural biomaterials (such as demineralized bone), and synthetic biomaterials (such as calcium sulfate, glycerol, and reverse phase polymeric compounds) that act as additives, fillers, and/or excipients (radioprotective agents, preservatives, and/or handling agents) to make the demineralized bone easier to manipulate. It should not be assumed that products evaluated favorably using this guidance will form bone when used in a clinical setting. The primary purpose of this guide is to facilitate the equitable comparison of unique bone-forming products in in vivo heterotopic models of osteoinductivity. The purpose of this guide is not to exclude other established methods.  
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 the use of DBM-containing bone-forming/promoting products. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the bone-forming/promoting capabilities of the product.  
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
    15 pages
    English language
    sale 15% off