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5.1 This is a quick, simple, and inexpensive test method for qualitatively determining, without the need to prepare bonded test specimens, whether the adhesive under consideration will bond to a particular substrate. If the results are acceptable, then standard quantitative adhesive test procedures can be used to obtain quantitative measurements of the adhesive's performance.5.2 This test method can also be used to compare relative adhesion of several adhesives to given substrates.5.3 It can be used to determine whether an adhesive will continue to adhere to the substrate under specified environmental conditions.5.4 It can be used to evaluate adhesion of a particular adhesive to a variety of substrates.5.5 It can be used to obtain “subjective” comparative data between several adhesives on a given substrate by noting the relative ease of inducing failure between the adhesives tested.5.6 It should be most applicable to adhesives that cure or set when exposed to “air” (ambient, heated, etc.) and could be used for anaerobic adhesives if testing is carried out in an oxygen-free atmosphere.1.1 This test method covers a simple qualitative procedure for quickly screening whether an adhesive will, under recommended application conditions, bond to a given substrate without actually making bonded assemblies.1.2 The values stated in SI units are to be regarded as the standard. The values in parentheses are for information only.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.

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4.1 The objective of this guide is to provide guidance in the characterization of Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs). This guide contains a listing of physical and chemical parameters that are directly related to the function of collagen. This guide can be used as an aid in the selection and characterization of the appropriate collagen starting material for the specific use. Not all tests or parameters are applicable to all uses of collagen.4.2 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) medical devices, tissue engineered medical products (TEMPs) or cell, drug, or DNA delivery devices for implantation. The use of collagen in a practical application should be based, among other factors, on 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 The following general areas should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs. These are source of collagen, chemical and physical characterization and testing, and impurities profile.4.4 The following documents or other appropriate guidances from appropriate regulatory bodies relating to the production, regulation, and regulatory approval of TEMPs products should be considered when determining if the collagen supplied satisfies requirements for use in TEMPs:FDA CFR:21 CFR 3: Product Jurisdiction:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=321 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=58 FDA/CDRH CFR and Guidances:21 CFR Part 803: Medical Device Reporting:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=80321 CFR 812: Investigational Device Exemptions:    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=81221 CFR 814: Premarket Approval of Medical Devices :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=81421 CFR 820: Quality System Regulation:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=820Design Control Guidance for Medical Device Manufacturers:   http://www.fda.gov/cdrh/comp/designgd.pdfPreproduction Quality Assurance Planning Recommendations for Medical Device Manufacturers (FDA 90-4236):   http://www.fda.gov/cdrh/manual/appende.htmlThe Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program—Draft Guidance for Industry and FDA Staff:   http://www.fda.gov/cdrh/comp/guidance/1602.pdf FDA/CDRH Search Engines:CDRH Guidance Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfggp/search.cfmCDRH Premarket Approval (PMA) Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfmCDRH 510(k) Search Engine:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfmCDRH Recognized STANDARDS Search Engine :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm FDA/CBER CFR and Guidances:21 CFR 312: Investigational New Drug Application :   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=31221 CFR 314: Applications for FDA Approval to Market a New Drug:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=3121 CFR 610: General Biological Products Standards:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=61021 CFR 1271: Human Cells, Tissues and Cellular and Tissue-Based Products:   http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/    CFRSearch.cfm?CFRPart=1271Cellular & Gene Therapy Guidances and Other Publications:   http://www.fda.gov/cber/genetherapy/gtpubs.htmHuman Tissue Guidances and Other Publications:   http://www.fda.gov/cber/tissue/docs.htmCBER Product Approval Information:   http://www.fda.gov/cber/efoi/approve.htm21 CFR 600, 601 BLA Regulations:   http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfrv7_07.html21 CFR 210, 211 GMP Regulations:   http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr210_07.html1.1 This guide for characterizing collagen-containing biomaterials is intended to provide characteristics, properties, and test methods for use by producers, manufacturers, and researchers to more clearly identify the specific collagen materials used. With greater than 20 types of collagen and the different properties of each, a single document would be cumbersome. This guide will focus on the characterization of Type I collagen, which is the most abundant collagen in mammals, especially in skin and bone. Collagen isolated from these sources may contain other types of collagen, for example, Type III and Type V. This guide does not provide specific parameters for any collagen product or mix of products or the acceptability of those products for the intended use. The collagen may be from any source including, but not limited to, animal or cadaveric sources, human cell culture, or recombinant sources. The biological, immunological, or toxicological properties of the collagen may vary, depending on the source material. The properties of the collagen prepared from each of the above sources must be thoroughly investigated, as the changes in the collagen properties as a function of source materials is not thoroughly understood. This guide is intended to focus on purified Type I collagen as a starting material for surgical implants and substrates for tissue engineered medical products (TEMPs); some methods may not be applicable for gelatin or tissue implants. This guide may serve as a template for characterization of other types of collagen.1.2 The biological response to collagen in soft tissue has been well documented by a history of clinical use (1, 2)2 and laboratory studies (3-6). Biocompatibility and appropriateness of use for a specific application(s) is the responsibility of the product manufacturer.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 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 following precautionary caveat pertains only to the test method portion, Section 5, of this guide. 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.

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5.1 This test method may be used for quantitative determinations of Pb in painted and unpainted articles such as toys, children’s products, and other consumer products. Typical test time for quantification of Pb in homogenous samples is 1 to 3 min; and typical test time for quantification of Pb in paint is 4 to 8 min.1.1 This test method uses energy dispersive X-ray fluorescence (EDXRF) spectrometry for detection and quantification of lead (Pb) in paint layers, similar coatings, or substrates and homogenous materials. The following material types were tested in the interlaboratory study for this standard test method: ABS plastic, polyethylene, polypropylene, PVC, glass, zinc alloy, wood, and fabric.1.2 This technique may also be commonly referred to as High Definition X-ray Fluorescence (HDXRF) or Multiple Monochromatic Beam EDXRF (MMB-EDXRF).1.3 This test method is applicable for the products and materials described in 1.1 for a Pb mass fraction range of 14 to 1200 mg/kg for uncoated samples and 30 to 450 mg/kg for coated samples, as specified in Table 1 and determined by an interlaboratory study using representative samples1.4 Ensure that the analysis area of the sample is visually uniform in appearance and at least as large as the X-ray excitation beam at the point of sample excitation.1.5 For coating analysis, this test method is limited to paint and similar coatings. Metallic coatings are not covered by this test method.1.6 X-ray Nomenclature—This standard names X-ray lines using the IUPAC convention with the Siegbahn convention in parentheses.1.7 There are no known ISO equivalent methods to this standard.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.

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3.1 This guide is intended as a reference for those concerned with the inspection of thin- or thick-film coating application to concrete and masonry substrates. It does not cover the application of cement-type coatings. The requirements for inspection should be addressed in all protective coating and lining work specifications. This guide may be used by specification writers when selecting and establishing the inspection requirements for coating and lining specifications. A sample checklist for use by inspectors is included as Appendix X1.1.1.1 This guide is intended as an information aid to painting inspectors in carrying out the task efficiently. It includes the key elements of surface preparation, coatings application, and final approval for both field and shop work. The items should be selected that are pertinent to a specific project.NOTE 1: For additional helpful information, refer to the following documents:Manual of Concrete Practice ACI 515R American Concrete Institute2Manual of Coating Work for Light Water Nuclear Power Plant Primary Containment and Other Safety Related Facilities3C811 Practice for Surface Preparation of Concrete for Application of Chemical-Resistant Resin Monolithic Surfacings4Steel Structures Painting Manual Vol. 1 - Good Painting Practices5Steel Structures Painting Manual Vol. 2 - Systems and Specifications5Manufacturers Specifications and Instructions (made available to the inspector for reference to special requirements for proper application)Safety Data Sheets (needed to ensure that personnel take necessary precautions in handling hazardous materials). Available from Materials manufacturer.1.2 Certain industries or owners may require certified inspection personnel. See Guide D4537 for establishing procedures to certify inspectors for coating work in nuclear facilities. SSPC offers a training and certification program for concrete coating inspection.51.3 In certain cases the inspector may be required to assess the condition of the concrete substrate. SSPC has published an illustrated guide for performing a concrete condition assessment.51.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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 guide is arranged in the following order:  SectionReferenced Documents 2  ASTM Standards 2.1  OSHA Standards 2.2  ICRI Standards 2.3  SSPC Standards 2.4 3Preparation for Inspection 4Surface Preparation Methods and Requirements 5  Surface Preparation 5.1  Factors Affecting Coating Performance 5.2  Surface Condition 5.2.1  Cleanliness 5.2.2  Moisture 5.2.3  Surface Preparation Procedures 5.3  Dry Surface Cleaning 5.3.1  Water and Steam Cleaning 5.3.2  Mechanical Tool Cleaning 5.3.3  Hand Tool Cleaning 5.3.3.1  Power Tool Cleaning 5.3.3.2  Scarifying Machines 5.3.3.3  Pre- and Post-Surface Preparation 5.3.3.4  Finished Surface 5.3.3.5  Blast Cleaning 5.3.4  Water Blast Cleaning 5.3.5  Acid Etching 5.3.6Precautions in Preparing Unpainted and   Previously Painted Surfaces 5.4Inspection of Surfaces Prior to Field Painting 5.5  New Construction 5.5.1  Maintenance Repainting 5.5.2Cracks and Voids 6  Cracks 6.1  Cracks in Concrete 6.1.1  Joints in Concrete 6.1.2  Voids 6.2  Recoat Intervals 6.3Coating Storage and Handling 7  Storage of Coating and Thinner 7.1  Mixing of Coatings 7.2  Thinning 7.3  Thinning of Coating 7.3.1  Heating of Coating 7.4Ambient Condition Considerations 8  Drying 8.1  Low Temperature 8.2  High Temperature 8.3  Moisture 8.4  Wind 8.5Coating Application 9  Residual Contaminants 9.1  Quality Assurance 9.2  Film Defects 9.2.1  Brush Application 9.3  Spray Application 9.4  Roller Application 9.5  Miscellaneous Methods 9.6  Rate of Application 9.7  Additional Considerations 10  Ventilation 10.1  Painting Schedule 10.2  Film Integrity 10.3  Recoat Time 10.4  Coating System Failure 10.5Inspection Equipment 11  General 11.1  Adhesion of Existing Coating 11.1.1  Portable Pull-Off Adhesion 11.1.2  Field Inspection Equipment 11.2  Drying and Curing Times 11.2.1  Thermometers 11.2.1.1  Psychrometric Charts 11.2.1.2  Wet-Film Thickness Gages 11.2.2  Interchemical Gage 11.2.2.1  Notched Gage 11.2.2.2  Dry-Film Thickness Gages 11.2.3  Destructive Thickness Gage 11.2.3.1  Nondestructive Film Thickness Gages 11.2.3.2  Discontinuity (Holiday) Tester 11.3Inspection Checklist Appendix X11.7 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.

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3.1 The procedure described in this practice is designed to provide a method by which the coating weight of chromium treatments on metal substrates may be determined.3.2 This procedure is applicable for determination of the total coating weight and the chromium coating weight of a chromium-containing treatment.1.1 This practice covers the use of X-ray fluorescence (XRF) techniques for determination of the coating weight of chromium treatments on metal substrates. These techniques are applicable for determination of the coating weight as chromium or total coating weight of a chromium-containing treatment, or both, on a variety of metal substrates.1.2 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.1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 This test method covers the procedure for the performance of calcium phosphate ceramic coatings in shear and bending fatigue modes. In the shear fatigue mode this test method evaluates the adhesive and cohesive properties of the coating on a metallic substrate. In the bending fatigue mode, this test method evaluates both the adhesion of the coating as well as the effects that the coating may have on the substrate material. These test methods are limited to testing in air at ambient temperature. These test methods are not intended for application in fatigue tests of components or devices; however, the test method that most closely replicates the actual loading configuration is preferred. 1.2 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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