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4.1 GeneralMeasurements and observations described in this document are used to assess the performance of an AM system with a given system set-up and process parameters, in combination with a specific feedstock material.The primary characterization of the AM system obtained by applying this document is via geometric accuracy, surface finish, and minimum feature sizes of the benchmarking test piece(s).4.2 Comparing results from one machineThe test piece(s) can be built and measured for example when the new machine is installed. The test piece(s) can be used to periodically evaluate the performance or diagnose a fault in one AM system, for example, after system maintenance or as specified by the requirements of a quality system.The test piece(s) described in this test method can be used as a demonstration of capabilities for a contract between a buyer and seller of AM parts or AM systems.Data from the measurements described in this document can be used to gauge the impact of new process parameters or material on the AM system performance.Certain test geometries can be included with every build on a particular AM system to help establish performance traceability. Depending on the needs of the user, not all test artefacts need to be built, and individual test artefacts can be built separately if required.1.1 This document covers the general description of benchmarking test piece geometries, i.e. artefacts, along with quantitative and qualitative measurements to be taken on the benchmarking test piece(s) to assess the performance of additive manufacturing (AM) systems.This performance assessment can serve the two following purposes:– AM system capability evaluation;– AM system calibration.The benchmarking test piece(s) is (are) primarily used to quantitatively assess the geometric performance of an AM system. This document describes a suite of test geometries, each designed to investigate one or more specific performance metrics and several example configurations of these geometries into test build(s). It prescribes quantities and qualities of the test geometries to be measured but does not dictate specific measurement methods. Various user applications can require various grades of performance. This document discusses examples of feature configurations, as well as measurement uncertainty requirements, to demonstrate low- and high-grade examination and performance. This document does not discuss a specific procedure or machine settings for manufacturing a test piece.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.

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4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648, or USP polyethylene negative control.1.2 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems 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.

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5.1 This guide presents options for a systematic assessment of fungal growth in buildings.5.2 This guide allows for site-specific flexibility and professional judgment in the choice of assessment procedures. It may not be necessary to perform in its entirety the basic assessment presented below to resolve a particular problem, for example, where fungal growth is localized and the source and extent of moisture is readily observable.5.3 Conversely, no matter how comprehensive the survey, all fungal growth may not be identified or located in a fungal assessment.5.4 Material removal or destructive investigation may be needed to access suspect surfaces.5.5 Using the procedures described in this guide, the investigator may have obtained the data necessary to suggest specific recommendations, for example, how to remediate the observed fungal growth, or how to prevent further fungal growth, but those recommendations are beyond the scope of this guide.5.6 Precautions may be needed to protect the assessor and building occupants where access may disturb fungal growth.5.7 It is the user’s responsibility to protect information that may be considered confidential, or private, or both, in accordance with project contract, corporate protocol, or local, state, and federal regulations, or a combination thereof.5.8 It may be necessary to enlist other disciplines or trade expertise to assist in some steps of the assessment, but recommendations of when to enlist and whom to enlist are beyond the scope of this guide.1.1 This guide provides a compendium of information and a menu of options for assessment of fungal growth in buildings, but does not recommend a specific course of action. Due to the wide variety of fungal problems affecting buildings and their occupants, and the wide variety of buildings, it is not possible to describe a set of uniform steps that will always be performed during an assessment (that is, a standard practice); therefore the user of this guide must decide which steps are appropriate for a given situation or building.1.2 This guide is specific to fungal growth, which is only one potential problem in a building environment. It may be part of, but is not intended to take the place of, a comprehensive indoor air quality investigation.1.3 This guide describes minimum steps and procedures for collecting background information on a building in question, procedures for evaluating the potential for moisture infiltration or collection, procedures for inspection for suspect fungal growth, and procedures beyond the scope of a basic survey that may be useful for specific problems.1.4 Assessments for fungal growth may be useful wherever fungal growth is suspected, excess moisture has been present or when there are concerns regarding potential fungal growth.1.5 Periodic fungal assessment in buildings may be a component of preventative maintenance programs.1.6 This guide is applicable to buildings including residential (for example, single or multi-family), institutional (for example, schools, hospitals), government, public assembly, commercial (for example, office, retail), and industrial facilities.1.7 Recommendations for developing a sampling strategy or methods for the collection and analysis of fungal samples are beyond the scope of this guide. For recommendations for developing a sampling strategy, see Ref (1)2, Chapter 10.1.8 Recommendations for remediation of fungal growth are beyond the scope of this guide.1.9 This guide is not intended to supersede any government regulations governing the assessment of fungal growth in buildings.1.10 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.1.11 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 Use—This practice is intended for use by parties who desire access to the national, or international, airspace as regulated by their respective CAA(s) either for a vehicle design (airworthiness) or a vehicle’s use (operational approval). In this practice, it is recognized the varying levels of complexity, need for risk assessment(s), and due diligence that should be determined in an ongoing dialogue between the CAA and the applicant. Users should consider their requirements, the purpose that the ORA is to serve, and their risk acceptance level before undertaking the ORA. Use of this practice does not preclude other initiatives or processes to identify hazardous conditions or assess and mitigate associated risks.5.2 Risk Reduced, not Eliminated—No ORA can eliminate all risk or uncertainty with regard to operations. Preparation of an ORA in accordance with this practice is intended to reduce, but may not necessarily completely eliminate, the risk of an operation in which system complexity is minimal, the operation is conducted in a lower risk environment, and the likelihood for harm to people or property, though present, is reduced to an acceptable level. As mission complexity increases, the operational environment may become less risk tolerant. For example, as the kinetic energy associated with the aircraft increases, more complex assessment/analysis tools and greater time may be required to conduct the ORA.1.1 This practice focuses on preparing operational risk assessments (ORAs) to be used for supporting small unmanned aircraft systems (sUAS) (aircraft under 55 lb (25 kg)) design, airworthiness, and subsequent operational applications to the civil aviation authority (CAA).1.2 It is expected that manufacturers and developers of larger/higher energy sUAS designs, intended to operate in controlled airspace over populated areas, will adopt many of the existing manned aircraft standards in use. These include standards such as SAE ARP4754A and ARP4761, which prescribe a “design for safety” top-down design approach to ensure the sUAS designs can reasonably meet more stringent qualitative and quantitative safety requirements. The ORA, however, remains the same for all risk profiles and will be a part of any sUAS operation.1.3 In mitigating and preventing incidents and accidents, it is understood that people generally do not seek to cause damage or injure others, and therefore, malicious acts are beyond the scope of this practice.1.4 As part of the ORA, the applicant should clearly understand and be able to articulate their intended mission for purposes of assessing safety and providing information to regulators. This documentation of a sUAS operation (mission, or set of missions) is what many refer to as a concept of operations (CONOPS).1.5 This practice is intended primarily for sUAS applicants seeking approval or certification for airworthiness or operations from their respective CAA, though sUAS manufacturers may consider this practice, along with other system safety design standards, as appropriate to identify sUAS design and operational requirements needed to mitigate hazards.1.6 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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 and health practices and determine the applicability of regulatory limitations prior to use.

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4.1 This guide is aimed at providing guidance for assessments and evaluations to aid in preclinical research and development of various absorbable components and devices.4.2 This guide includes brief descriptions of various intended uses, processing conditions, assessments, and both qualitative and quantitative analyses for raw materials to finished product components.4.3 The user is encouraged to utilize appropriate ASTM and other standards to conduct the physical, chemical, mechanical, biocompatibility, and preclinical tests on absorbable materials, device components, or devices prior to assessment in an in vivo model.4.4 Whenever an absorbable material is mixed or coated with other substances (bioactive, polymeric, or otherwise), the physical and degradation properties of the resulting composite may differ significantly from the base polymer. Thus, unless prior experience can justify otherwise, performance characterizations described herein should be conducted on the composite construct rather than on individual components.4.5 Assessments of absorbable materials should be performed in accordance with the provisions of the FDA Good Laboratories Practices Regulations 21 CFR 58, where feasible.4.6 Studies to support regulatory approval for clinical or commercial use, or both, should conform to appropriate nationally adopted directives or guidelines, or both, for the development of medical devices [for example, CE approval; US-FDA Investigational Device Exemption (IDE), Pre- Market Approval (PMA), or 510K submission].4.7 Assessments based upon data from physical, chemical, mechanical, biocompatibility, and preclinical testing models are highly valuable but carry inherent limitations. Thus, the clinical relevance of each assessment needs to be carefully considered and the user is cautioned that pre-clinical evaluations may not be predictive of human clinical performance.1.1 This guide describes general guidelines for the chemical, physical, mechanical, biocompatibility, and preclinical assessments of implantable synthetic polymeric absorbable devices. This guide also describes evaluation methods that are potentially useful and should be considered when assessing absorbable implants or implant components.1.2 The described evaluations may assist a manufacturer in establishing the safety and effectiveness of an absorbable implant device. This listing of assessment methods may also be utilized to assist in establishing substantial equivalence to an existing commercially marketed device. However, these polymeric material-oriented guidelines do not necessarily reflect the total needs for any particular implant application (for example, orthopedic, cardiovascular, sutures, and dermal fillers), which may require additional and potentially essential application-specific evaluations.1.3 This guide is intended to cover all forms of absorbable polymeric components and devices, including solid (for example, injection-molded) and porous (for example, fibrous) forms. This guide is also intended to cover devices fabricated from amorphous and/or semi-crystalline absorbable polymer systems.1.4 This guide has been generated with principal emphasis on the evaluation of devices formed from synthetic polymers that degrade in vivo primarily through hydrolysis (for example, α-hydroxy-polyesters). Evaluation methods suggested herein may or may not be applicable to implants formed from materials that, upon implantation, are substantially degraded through other mechanisms (for example, enzymatically induced degradation).1.5 This guide references and generally describes various means to assess absorbable materials, components, and devices. The user needs to refer to specific test methods for additional details. Additionally, some of the recommended test methods may require modification to address the properties of a particular device, construct, or application.1.6 Adherence to all aspects of these guidelines is not mandatory, in that assessments and tests listed within this guide are not necessarily relevant for all absorbable implant systems and applications.1.7 Absorbable polymers used as a matrix to control the in vivo release of bioactive agents (drugs, antimicrobials, and so forth) may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate a bioactive agent’s composition, loading, release kinetics, safety, and efficacy.1.8 Composites of absorbable polymers with ceramics and/or metals may be evaluated according to many of the methods described herein. However, additional test methods not covered by this guide will likely be needed to evaluate the composite’s other component(s).1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.10 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.1.11 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 practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years.5.2 This practice is similar to those for studies on candidate materials or medical devices that are not absorbable, such as those specified in Practices F763, F981, and F1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site, as well as the potential for adverse distal tissue effects.5.3 For testing of absorbable medical devices, the test article for implantation should be in the final finished form as for intended use, including packaging and sterilization (if applicable). Configurations specific to the animal study may be needed. The test article’s surface-area-to-body mass or mass-to-body mass ratios within the animal model should be established by calculating based on surface-area-to-body mass or mass-to-body mass ratios in humans during the device’s intended clinical use. Worst-case clinical dose should be considered in the study design. For implantation studies incorporating evaluation of both local tissue responses and systemic toxicity, exaggerated material surface area or mass-to-body mass ratios (for example, a 2X to 10X safety factor to assess implant safety for regulatory submissions) compared to clinical use (for example, largest device size, maximum number of devices) should be considered, unless otherwise justified. For example, implantation of exaggerated doses may not be feasible in the selected animal model. For some devices, additional animal group(s) for exaggerated conditions should be considered if dose response information is needed. Additionally, for some devices, exaggerated dose at a specific implantation site can also be used to evaluate local tissue responses.5.4 Materials that are designed for use in devices with in situ polymerization shall be introduced in a manner such that in situ polymerization occurs. Additional testing of individual precursor components or partially polymerized materials may be needed in some cases (for example, if testing of the final implant indicates an adverse response or incomplete polymerization).1.1 This practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations.1.2 The time period for implant absorption can depend on variables of chemical composition, implant size, implant location, and animal models. Therefore, the selected time points for assessing tissue effects may be selected based on the rate of absorption.1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. They do not fully assess systemic toxicity, carcinogenicity, reproductive and development toxicity, or mutagenicity of the material. Other standards are available to address these issues.1.4 To maximize use of the animals in the study protocol, some aspects of systemic toxicity, including effects of degradation products on different organs and tissues downstream of or surrounding the target site, can be addressed with this practice.1.5 Because animal models are not identical to human biology, this practice cannot account for all potential biological hazards, for example the effect of the oligosaccharide a-Gal (Gala 1,3-Galb1-4GlcNAc-R), known as the “a-Gal” epitope present in xenogeneic materials on humans. See ISO 22442.1.6 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.

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