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America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC) Standards Landscape (version 2.0, June 2018)Developer3MF ConsortiumDesignation / Title of Standard, Specification, or Other PublicationAAMIAAMI3D Manufacturing Format (3MF)AAMI TIR12:2010, Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guidefor medical device manufacturersAAMI TIR17:2008, Compatibility of materials subject to sterilizationAAMI TIR30:2011 (R2016), A compendium of processes, materials, test methods, and acceptance criteria for cleaningreusable medical devicesAAMI TIR37:2013, Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-basedproductsANSI/AAMI ST67:2011 (R2017), Sterilization of health care products - Requirements and guidance for selecting a sterilityassurance level (SAL) for products labeled 'sterile'ANSI/AAMI/ISO 10993-1:2009(R2013), Biological evaluation of medical devices - Part 1:Evaluation and testing within a riskmanagement processANSI/AAMI/ISO 10993-15:2000 (R2011), Biological evaluation of medical devices - Part 15: Identification and quantificationof degradation products from metals and alloysANSI/AAMI/ISO 11135: 2014, Sterilization of health care products - Ethylene oxide - Requirements for development,validation and routine control of a sterilization process for medical deviceANSI/AAMI/ISO 11137, Sterilization of Health Care Products Package; ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2 andANSI/AAMI/ISO 11137-3ANSI/AAMI/ISO 11607-1:2006 (R2010), Packaging for terminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging (INCLUDES AMENDMENT 1)ANSI/AAMI/ISO 11607-2:2006 (R2010), Packaging for terminally sterilized medical devices - Part 2: Validation requirementsfor forming, sealing and assembly processes (INCLUDES AMENDMENT1)ANSI/AAMI/ISO 13022:2012, Medical products containing viable human cells - Application of risk management andrequirements for processing practicesANSI/AAMI/ISO 13408, Aseptic Processing of Health Care Products PackageAAMIANSI/AAMI/ISO 14160:2011 (R2016), Sterilization of health care products - Liquid chemical sterilizing agents for single-usemedical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validationand routine control of a sterilization process for medical IAAMIAAMIAAMIAAMIABSABSABSABSPage 1 of 20ANSI/AAMI/ISO 14937:2009 (R2013), Sterilization of healthcare products -General requirements for characterization of asterilizing agent and the development, validation and routine control of a sterilization process for medical devicesANSI/AAMI/ISO 17664:2017, Processing of health care products - Information to be provided by the medical devicemanufacturer for the processing of medical devices (supersedes ST81)ANSI/AAMI/ISO 17665-1:2006 (R2013), Sterilization of health care products - Moist heat - Part1: Requirements for thedevelopment, validation, and routine control of a sterilization process for medical devicesANSI/AAMI/ISO 20857:2010 (R2015), Sterilization of health care products - Dry heat - Requirements for the development,validation and routine control of a sterilization process for medical devicesABS Volume 1, Guidance Notes on the Application of Cybersecurity Principles to Marine and Offshore Operations (revisedand expanded)ABS Volume 2, Guide for Cybersecurity Implementation for the Marine and Offshore IndustriesABS Volume 3, Guidance Notes on Data Integrity for Marine and Offshore OperationsABS Volume 4, Guide for Software Systems VerificationPublicationDate / TargetDate2015PublicationStatusNew esYesYesNoNoNoNo 2018 ANSI/NCDMM/America Makes

America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC) Standards Landscape (version 2.0, June 2018)DeveloperABSDesignation / Title of Standard, Specification, or Other PublicationPublicationDate / TargetDate2016PublicationStatusNew NoYesNoNoNoNoYesYesNoNoNoNoNoACCAIAASMEASMEASME B107ASME B107ASME B107ASME B107ASME B107ASME B107ASME B107ASME B46ABS Volume 5, Guidance Notes on Software Provider Conformity ProgramANSI Z400.1/Z129.1-2010, Hazardous Workplace Chemicals - Hazard Evaluation and Safety Data Sheet and PrecautionaryLabeling PreparationNAS 410 Rev.4, NAS Certification & Qualification of Nondestructive Test Personnel, 2014 EditionASME B16.5/ASME B16.10/ASME B16.34, Valves and Fittings PackageASME B31.1 / B31.3, Power and Process Piping PackageASME B107.100-2010, Flat WrenchesASME B107.110-2012, Socket Wrenches, Handles, and AttachmentsASME B107.300-2010 (R2016), Torque InstrumentsASME B107.400-2008, Striking ToolsASME B107.410-2008, Struck ToolsASME B107.500-2010, PliersASME B107.600-2016, Screwdrivers and Screwdriver BitsASME B46.1-2009, Surface Texture (Surface Roughness, Waviness, and Lay)ASME B89ASME B89.4.23-201x, X-ray Computed Tomography (CT) Performance Evaluation StandardASME BPTCS/BNCSASME BPVCASME V&V 40ASME XXX-2019, Use of Additive Manufacturing for Pressure Retaining EquipmentASME Boiler and Pressure Vessel Code - 2017 EditionASME V&V 40, Assessing Credibility of Computational Models through Verification and Validation: Application to MedicalDevicesASME V&V 50ASME Y14ASME Y14ASME Y14ASME Y14ASME V&V 50, Verification and Validation of Computational Modeling for Advanced ManufacturingANSI/ASME Y14.36M-1996 (R2008), Surface Texture SymbolsASME Y14.100-2017, Engineering Drawing PracticesASME Y14.41-2012, Digital Product Definition Data PracticesASME Y14.46-2017, Product Definition for Additive Manufacturing [Draft Standard for Trial Use]ASME Y14ASME Y14.47-201x, Model Organization Schema PracticesASME Y14ASME Y14ASME Y14.48, Universal Direction and Load IndicatorsASME Y14.5:2009, Dimensoning and ishedPublishedPublished(New) InDevelopment(New) InDevelopmentPublished(New) InDevelopment(New) New) InDevelopment(New) InDevelopmentPublishedASSPANSI/AIHA/ASSP Z9.2-2012, Fundamentals Governing the Design and Operation of Local Exhaust Ventilation SSPANSI/AIHA/ASSP Z9.4-2011 Abrasive-Blasting Operations – Ventilation and Safe Practices for Fixed Location EnclosuresANSI/AIHA/ASSP Z9.5-2012, Laboratory VentilationANSI/AIHA/ASSP Z9.6-2008, Exhaust Systems for Grinding, Polishing and BuffingANSI/AIHA/ASSP Z9.7-2007, Recirculation of Air from Industrial Process Exhaust SystemsANSI/AIHA/ASSP Z9.9-2010, Portable Ventilation SystemsANSI/ASSP Z10-2012 (R2017), Occupational Health and Safety Management SystemsANSI/ASSP Z244.1-2016, The Control of Hazardous Energy Lockout, Tagout and Alternative sYesYesYesYesYesYesNoNoNoNoNoNoNoASSPANSI/ASSP Z590.3-2011 (R2016), Guidelines for Addressing Occupational Hazards and Risks in Design and Redesign Processes2016PublishedYesNoPage 2 of 00920172008201720122017 2018 ANSI/NCDMM/America Makes

America Makes & ANSI Additive Manufacturing Standardization Collaborative (AMSC) Standards Landscape (version 2.0, June 2018)DeveloperDesignation / Title of Standard, Specification, or Other PublicationPublicationDate / TargetDate2011PublicationStatusNew tov2?AMSpecific?PublishedYesNoASSPANSI/ASSP Z690.1-2011, Vocabulary for Risk Management (National Adoption of: ISO Guide 73:2009)ASSPASSPANSI/ASSP Z690.2-2011, Risk Management - Principles and Guidelines (Identical National Adoption of: ISO 31000:2009)ANSI/ASSP Z690.3-2011, Risk ASSPssment Techniques (National Adoption of: IEC/ISO 31010:2009)ANSI/ASSP Z9.10-2017, Fundamentals Governing the Design and Operation of Dilution Ventilation Systems in dYesYesNoNo20142002PublishedPublishedYesNoNoNoASTM A01.14ANSI/ASSP Z9.1-2016, Ventilation and Control of Airborne Contaminants During Open-Surface Tank OperationsANSI/ASSP Z9.3-2017, Spray Finishing Operations: Safety Code for Design, Construction and VentilationISO/ANSI/ASSP TR-31004-2014, Risk Management - Guidance for the Implementation of ISO 31000 (identical nationaladoption of ISO/TR 31004:2013)MNL45, Radiation Curing of CoatingsASTM A380/A390M-17, Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, andSystems2017PublishedNoNoASTM A01.14ASTM A967/A967M-17, Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts2017PublishedNoNoASTM A01.182015PublishedNoNo2014PublishedYesNoASTM A01.22ASTM A04.21ASTM B07.01ASTM A1080-15, Standard Practice for Hot Isostatic Pressing of Steel, Stainless Steel, and Related Alloy CastingsASTM A858/A858M-14, Standard Specification for Heat-Treated Carbon Steel Fittings for Low-Temperature and CorrosiveServiceASTM A988/A988M-17, Standard Specification for Hot Isostatically-Pressed Stainless Steel Flanges, Fittings, Valves, and Partsfor High Temperature ServiceASTM A247-17, Standard Test Method for Evaluating the Microstructure of Graphite in Iron CastingsASTM B998-17, Standard Guide for Hot Isostatic Pressing (HIP) of Aluminum Alloy oYesNoASTM B07.05ASTM B557-15, Standard Test Methods for Tension Testing Wrought and Cast Aluminum- and Magnesium-Alloy Products2015PublishedNoNoASTM B07.05ASTM B07.05ASTM B645-10 (2015), Standard Practice for Linear-Elastic Plane–Strain Fracture Toughness Testing of Aluminum AlloysASTM B646-17, Standard Practice for Fracture Toughness Testing of Aluminum AlloysASTM B962-17, Standard Test Methods for Density of Compacted or Sintered Powder Metallurgy (PM) Products UsingArchimedes’ PrincipleASTM B985-12, Standard Practice for Sampling Aluminum Ingots, Billets, Castings and Finished or Semi-Finished WroughtAluminum Products for Compositional AnalysisASTM B851-04 (2014), Standard Specification for Automated Controlled Shot Peening of Metallic Articles Prior to Nickel,Autocatalytic Nickel, or Chromium Plating, or as Final FinishASTM B243-17, Standard Terminology of Powder shedNoNoNoNoASTM B212-17, Standard Test Method for Apparent Density of Free-Flowing Metal Powders Using the Hall Flowmeter FunnelASTM B213-17, Standard Test Methods for Flow Rate of Metal Powders Using the Hall Flowmeter FunnelASTM B214-16, Standard Test Method for Sieve Analysis of Metal PowdersASTM B215-15, Standard Practices for Sampling Metal PowdersASTM B822-17, Standard Test Method for Particle Size Distribution of Metal Powders and Related Compounds by oASSPASSPASSPASSPASTMASTM A01.22ASTM B07.05ASTM B07.05ASTM B08.02ASTM B09.01ASTM B09.02ASTM B09.02ASTM B09.02ASTM B09.02ASTM B09.02Page 3 of 20 2018 ANSI/NCDMM/America Makes