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Aluminum. especially when alloyed with one or more of several common elements, has been increasingly specified and used in packaging, architectural, transportation, chemical, electrical and many general applications. Today, aluminum is surpassed only by steel in its use as a structural material. The properties of aluminum and its alloys which give rise to their widespread usage, with particular emphasis on manufacturability, recyclability, and corrosion resistance, are briefly described in this report. The designation system by which alloys are classified is also described, and references are provided for the reader who may desire more detailed information.
Explains the various methods of brazing aluminum, and includes charts and tables to help designers plan brazing operations
The 2015 Aluminum Design Manual is essential for all professionals who work with aluminum in structural applications, this comprehensive, up-to-date resource includes: Specification for Aluminum Structures: (US units) The 2015 Specification for Aluminum Structures is the first unified allowable strength design and load and resistance factor design aluminum Specification. It provides rules for determining the strength of aluminum structural components and minimum strengths for wrought, cast, and welded aluminum alloys and aluminum fasteners; Commentary: (US units) discusses the provisions in the Specification for Aluminum Structures and provides references; Design Guide: ( US units) addresses structural design issues not included in the Specification for Aluminum Structures, including diaphragms, adhesive bonded joints, aluminum composite material, extrusion design, corrosion prevention, fire protection, sustainability, and design references for aluminum structural components in automobiles, bridges, rail cars, ships, pressure vessels, pipe, and storage tanks; Material Properties: (US and SI units) includes alloy and temper designation systems for wrought and cast aluminum alloys; comparative characteristics of wrought alloys; foreign alloy designations correlated with US alloy designations; and typical mechanical and physical properties, including thermal expansion, electrical conductivity, and density ; Section Properties: (US units) lists dimensions and section properties for aluminum channels, I-beams, angles, tees, zees, square and rectangular tube, round tube, pipe, and roofing and siding, as well as sheet metal and wire gauges; Design Aids: (US units) provides buckling constants, allowable stress tables for various alloys, allowable load tables for channels and I-beams in bending, tread plate, roofing and siding; fastener strengths, minimum bend radii for aluminum sheet and plate, wire, and rod, design stresses for groove and fillet welds, and beam formulas; Illustrative Design Examples: (US units) includes structural design calculation examples based on the Specification for Aluminum Structures; The Aluminum Design Manual can be ordered in printed form or as a downloadable pdf file. Errata pages are available on the standards department page of The Aluminum Association website ISBN: 9780986363108
The 2020 Aluminum Design Manual is essential for all professionals who work with aluminum in structural applications, this comprehensive, up-to-date resource includes the sections listed below *The Specification for Aluminum Structures, which contains new provisions for block shear, pull-out strength of screws in screw chases, weld-affected strengths, post-weld heat treated strengths, new alloy-tempers, and flanges and webs with concentrated forces *The Commentary to the Specification for Aluminum Structures, with background and references for specification provisions *A Design Guide, addressing aluminum structural design codes, aluminum composite material, adhesive bonded joints, extrusion design, corrosion, fire protection, and sustainability *Material Properties, which describes the wrought and cast alloy and temper designation systems and provides comparative characteristics, typical physical properties, and densities of common aluminum alloys *Section Properties for common aluminum channels, I-shapes, angles, tees, zees, square, rectangular, and round tube, roofing and siding, and pipe *Design Aids, including 48 allowable stress tables for common alloy-tempers, load span tables for Aluminum Association channels and I-shapes, grating (new), tread plate, and roofing and siding *Illustrative Examples, with 31 design examples of use of the Specification for Aluminum Structures *Guidelines for Aluminum Sheet Metal Work in Building Construction *A new Code of Standard Practice for Fabricating and Erecting Structural Aluminum, which provides a common understanding of acceptable standards when contracting for structural aluminum *Hard copies include a QR code with a link to a spreadsheet containing section property
A comprehensive guide to the history, production, and application of aluminum foil.
The 2013 edition of American National Standard Alloy relocation of footnote references for clarity; and addition of a footnote to require individual limits for combination of elements in excess of 0.10%. Additionally, a definition for O2 temper designation has been added as a reserved temper to demonstrate response to annealing.
The 2013 edition of American National Standard Dimensional Tolerances for Aluminum Mill Products supersedes the 2009 edition. This latest revision consists of modification to the column heading for extruded and drawn pipe to harmonize with ANSI/ASME standard; clarification on tolerance calculation for wall thickness (eccentricity) of extruded tube; and clarifications to table headings and footnotes.
The 2013 edition of American National Standard Dimensional Tolerances for Aluminum Mill Products (Metric version) supersedes the 2009 edition. This latest revision consists of modification to the column headings and pipe size units for extruded and drawn pipe to harmonize with ANSI/ASME standard; clarification on tolerance calculation for wall thickness (eccentricity) of extruded tube; and clarifications to table headings and footnotes.
The 2013 edition of American National Standard Designation System for Aluminum Hardeners reaffirms the 1997 standard.
The 2013 edition of American National Standard Designation System for Unalloyed Aluminum reaffirms the 2006 standard. This standard provides a system for designating unalloyed aluminum not made by a refining process and used primarily for remelting.
The 2013 edition of American National Standard Nomenclature System for Aluminum Metal Matrix Composite Materials is a revision of 1993 edition. This Standard was developed to provide users, producers and other interested parties with a means of briefly describing aluminum matrix composites utilizing the already existing Alloy and Temper Designation Systems for Aluminum, American National Standard H35.1 / H35.1(M).
ASD Overview: The 2013 edition of Aluminum Standards and Data is a revision to 2009 edition. This indispensable reference consists of three main parts; blue pages, yellow pages and white pages as follows: The first three sections of the blue pages contain information on aluminum characteristics, alloy and temper designations, mill product specifications, nominal composition , Typical mechanical and physical properties, density calculation procedure, comparative characteristics and application, fabrication/ heat treatments of wrought aluminum and wrought aluminum alloy products; The fourth section of blue pages describes quality control and guidelines for testing, inspection, and identification; The fifth section (yellow pages) lists the terminology associated with wrought aluminum products; The first section of white pages covers standard limits for chemical composition, mechanical properties, physical properties and dimensional tolerances for wrought aluminum mill products; Designations for clad products; chemical composition limits and; The remaining nine sections (white pages) consist of standards for chemical composition, limits, mechanical property limits, dimensional tolerances, and other data classified by product form. The tolerances are those included in the ANSI H35.2 Standard Tolerances for Aluminum Mill Products. In addition, the latest 2013 edition of American National Standards Alloy and Temper Designation for Aluminum, ANSI H35.1/H35.1M, is reprinted in the blue section of this document.
ASD Overview: The 2013 edition of Aluminum Standards and Data is a revision to 2009 edition. This indispensable reference consists of three main parts; blue pages, yellow pages and white pages as follows: The first three sections of the blue pages contain information on aluminum characteristics, alloy and temper designations, mill product specifications, nominal composition , Typical mechanical and physical properties, density calculation procedure, comparative characteristics and application, fabrication/ heat treatments of wrought aluminum and wrought aluminum alloy products; The fourth section of blue pages describes quality control and guidelines for testing, inspection, and identification; The fifth section (yellow pages) lists the terminology associated with wrought aluminum products; The first section of white pages covers standard limits for chemical composition, mechanical properties, physical properties and dimensional tolerances for wrought aluminum mill products; Designations for clad products; chemical composition limits and; The remaining nine sections (white pages) consist of standards for chemical composition, limits, mechanical property limits, dimensional tolerances, and other data classified by product form. The tolerances are those included in the ANSI H35.2 Standard Tolerances for Aluminum Mill Products. In addition, the latest 2013 edition of American National Standards Alloy and Temper Designation for Aluminum, ANSI H35.1/H35.1M, is reprinted in the blue section of this document.
For use by engineers and specifiers that need to know the specifics of how, when and why to solder aluminum. This is a practical publication that covers materials, cleaning, fixture and joint design, brazing methods and equipment, inspection, testing and safety. It is a guide to the technology that enables relatively low-temperature, thermal-joining of aluminum to aluminum and others metals. It makes aluminum soldering relatively simple; however, it does provide detailed explanations needed for thorough understanding. Reviews soldering methods and includes sections on material, cleaning, fixture design and inspection techniques. (74 pages)
The Aluminum Soldering Handbook attempts to cover the issues involved in doing soldering of aluminum. The book looked at the variety of aluminum alloys and their corresponding solderability. It looked at issues of how to clean aluminum, how to make various solder joints, processes used for soldering, corrosion issues, and soldering joint evaluation methods. The older version of the book concentrated on the use of mostly high temperature "hard" solders for making aluminum connections. The new version of the book looks closer to aluminum cleaning, aluminum soldering methods, and aluminum to other metal soldering considerations. The book also concentrates on a much wider variation of soft soldering solder alloys that can be used for doing aluminum soldering. The book reviews new methods that have been developed using a wider variety of fluoride containing organic fluxes, aluminum flux-cored wire solder, direct aluminum solderpaste, and aluminum tinning chemistries. Finally, the new book discusses how these new methods can be used to address some of the most difficult aluminum soldering needs.
The "Aluminum Statistical Review" is assembles in one place the most important statistical data available on the North American aluminum industry. It includes information on every cycle of the aluminum production process; from primary aluminum, to markets for finished goods, to the recovery of aluminum scrap. The Review is divided into five major sections: supply, shipments, markets, foreign trade, and world statistics. Its easy-to-read design includes text, tables and charts providing a valuable reference tool for members of the industry, financial analysts, government agencies, students, and the general public.
Completely revised and updated in 2008. Details cleaning methods for mill-finished, anodized, chemical-coated, painted, porcelain enameled, plated and laminated aluminum finishes. It includes applications for architecture, transportation and home use. Also lists products, and manufacturers of products, for the care of aluminum, such as abrasive cleaners, etching cleaners, solvent and emulsion cleaners, clear organic coatings, mastic coatings, protective tapes and waxes and wipe-on coatings. (24 pages)
Aluminum Oxide, Aluminum, and Aluminum Alloys may require facility and/or corporate reporting under the EPA's Toxic Substance Control Act (TSCA) Chemical Date Reporting Rule. This document provides guidance on the proper reporting of these materials consistent with the rule requirements and includes a number of industry specific examples about compliance with the reporting obligations.
Provides a concise guide to the behavior of aluminum with a wide variety of food and chemicals. (72 pages)
Revised in 2003 (Reaffirmed in Jan., 2009). Outlines a system of designations for all types of finishes and coatings commonly applied to aluminum. Examples of designations for mechanical and chemical finishes and anodic coatings illustrate how the system is used. (8 pages)
Designing Aluminum Screened Enclosures addresses structural design of screened enclosures based on the Florida Building Code, including: - Dead, live, and wind loads for primary and secondary members - Structural analysis to determine forces and moments and deflections - Aluminum extrusion strengths - Member design, including allowable stresses for axial compression, axial tension, shear, major and minor axis bending, and section properties of self-mating beams and tubes - Connection design, including gussets and fasteners (bolts, screws, and concrete anchors) - Construction documents addressing design, materials, fabrication, and construction issues High Velocity Hurricane Zones (HVHZ) and non-HVHZ applications are addressed.
Revised in 2008. This publication discusses how to alleviate potential hazards caused by particles of aluminum so fine that they could result in explosions during fabricating operations such as grinding, sanding and sawing. Also contains specific fire prevention and protection tips. (8 pages)
In 2017, six Aluminum Association member companies submitted 39 fabrics and combinations of fabrics for testing of their protective performance in contact with molten aluminum. Testing was conducted in accordance with the ASTM 955 Test Method with slight variations in some cases as noted. This report provides ratings of all samples tested in the areas of ignition, metal adhesion, shrinkage, break open, and char as well as Stoll Curves (thermal conductivity over time) and before/after photographs for all samples tested.
Outlines the steps, practices and equipment used to reduce the potential hazards of molten metal in melting, transferring and casting operations. Industry research on the causes and prevention of molten metal explosions is described. (84 pages)
This registration record is the defining source for the international designations and chemical composition limits for unalloyed aluminum referenced in a number of standards and specifications worldwide. Key updates to this publication include: • Clarification of the prefix P as well as the testing and reporting requirements for unalloyed aluminum not made by a refining process. • The Chemical Composition Table has been reformatted to group together each basic unalloyed aluminum and its variations. • Updates were made to the appendices and Declaration of Accord to clarify language • An appendix was added to include information about keeping registrations and designations current
This publication includes designations, chemical composition limits and color codes for aluminum hardeners registered in accordance with the International Designation System for Aluminum Hardeners.
Intended to help companies that produce and/or melt aluminum sows, and addresses casting, inspection, drying and melting procedures. The focus of this book is to prevent equipment damage and injuries associated with explosions that are caused by wet or contaminated sows charged into molten metal in melting furnaces. The Guidelines offer information and suggestions, derived from industry experience, for plants to consider in their safety programs. This edition includes a new section on the proper pre-treatment of sow produced from recycled aluminum, including storage and drying parameters. (18 pages)
Helps aluminum recyclers and scrap suppliers prevent accidents and injuries due to moisture or contamination in purchased scrap. This publications reviews scrap-related health and safety hazards, scrap receiving and inspection, contaminated scrap procedures and The Aluminum Association's molten metal incident reporting system. (32 pages)
The 2014 Edition of the Gray Sheets supersedes the 2007 edition. This publication includes designations, chemical composition limits and color codes for aluminum hardeners registered in accordance with the International Designation System for Aluminum Hardeners. Additionally the American National Standard ANSI H35.4, Designation System for Aluminum Hardeners, is printed as Recommendation on page 11 of this publication. Key updates in this new edition consist of inclusion of new registered aluminum hardeners; addition of associated terms and definitions with aluminum hardeners as Appendix A; revisions to ?Declaration of Accord? on the international designation system for aluminum hardeners and revisions to ?Color Scheme? for determining color codes for aluminum hardeners. (Gray Sheets) Twenty four pages. July, 2007, supersedes January, 2000.
This publication is the registration record for clad aluminum alloy products registered with The Aluminum Association, and contains the registered designations, component alloys, cladding location, and other information. The new version of this publicaiton has one new clad alloy combination, and removed four others.
This publicaton is the registration record for clad aluminum alloy products registered with The Aluminum Association, and contains the registered designations, component alloys, cladding location, and other information on the registered products, as well as a list of those products that have been deactivated, a description of the designations for clad products, and the information required to register a clad product for inclusion in the registration record.
The North America Aluminum Industry Extrusion Press Directory, Fourth Edition, contains information on all aluminum extrusion plants that have been identified in Canada, Mexico and the United States. Information contained in the Press Directory is the result of industry surveys and research conducted by the Aluminum Association. As of the end of 2014, there are 145 companies producing aluminum extruded products in North America, operating 205 plants and 526 extrusion presses. The Directory lists these companies, plants, locations, numbers and sizes of extrusion presses, and additional capabilities and services. Also contains a listing of billet producers, links to web sites and email addresses, and glossary. Download in PDF format with additional information in MS Excel (86 pages)
This registration record is the defining source for the international designations and chemical composition limits for unalloyed aluminum referenced in a number of standards and specifications worldwide. Other information includes a list of inactive registrations, the Declaration of Accord on the International Designation System for Unalloyed Aluminum and a list of the Signatories to the Accord. Twelve pages. Revised in March, 2007, supersedes May, 2003
This registration record contains designations and chemical composition limits registered with The Aluminum Association for aluminum and aluminum alloys in the form of castings and ingot. In the latest 2018 edition, 34 new alloys were added, two alloys were inactivated and one new footnote was added; this version supersedes the previous 2009 edition.
This registration record is the defining source for the international designations and chemical composition limits for unalloyed aluminum referenced in a number of standards and specifications worldwide. Other information includes a list of inactive registrations, the Declaration of Accord on the International Designation System for Unalloyed Aluminum and a list of the Signatories to the Accord. Twelve pages.
Listed herein are designations and chemical composition limits for aluminum alloys in the form of castings or ingot registered with The Aluminum Association. This list is maintained by the Technical Committee on Product Standards of The Aluminum Association. The designations of these compositions were assigned in conformance with the system adopted by The Aluminum Association in 1954 and approved by the American Standards Association (now American National Standards Institute Incorporated) as an American Standard in 1957 (see American National Standard Alloy and Temper Designation Systems for Aluminum ANSI H35.1/H35.1(M)).
Visual quality attributes of aluminum extrustions have been complied as a reference for thos who have an interest in aluminum extruded products and who have an interest in terminology commonly used in this segment of the aluminum industry.
This publication sets the preferred terms and definitions of cause for the visual quality attributes of aluminum extrusions along with some illustrations.
A pictorial publication which sets the correct terminology and definitions of cause for the attributes discussed. Two separate indexing systems for more than 150 attributes help the user identify the visual quality aspect being sought. (36 pages)
This publication was developed for educational purposes and provides a broad description of how aluminum sheet and plate fabricated products are manufactured in an aluminum sheet mill. It enlarges upon the information presented in the DVD of the same name.
This manual gives voluntary guidelines covering chemical compositions and physical and mechanical properties. Also covered are linear tolerances, draft requirements, machine-finish allowances, quality control and heat treatments. Provides engineering and metallurgical standards for users and producers, and coordinates American National Standards for casting and facilitates casting alloy, ingot and temper registration. Now with metric as well as U.S. units of measurement. (57 pages) Includes the following Standards: AA-CS-E1-92, AA-CS-E2-92, AA-CS-E3-92, AA-CS-E4-92, AA-CS-E5-92, AA-CS-E6-2000, AA-CS-E7-2000, AA-CS-E8-92, AA-CS-E9-92, AA-CS-E10-2000, AA-CS-E11-92, AA-CS-E12-92, AA-CS-E13-92, AA-CS-E14-92, AA-CS-E15-92, AA-CS-E16-2000, AA-CS-E18-92, AA-CS-E19-92, ,AA-CS-E20-92, AA-CS-E21-74, AA-CS-M1-85, AA-CS-M2-84, AA-CS-M3-2000, AA-CS-M4-84, AA-CS-M5-92, AA-CS-M5-85, AA-CS-M6-85, AA-CS-M7-85, AA-CS-M8-85, AA-CS-M9-74, AA-CS-M10-84 ,AA-CS-M11-85
This manual provides guidelines covering chemical compositions and physical and mechanical properties; it is divided into two sections * ENGINEERING SERIES (E), which establishes metrics for the various tolerances, precisions, allowances and finishes applicable to unmachined cast aluminum products, and * METALLURGICAL SERIES (M), which delves into the properties of the various aluminum alloys and tempers frequently used in casting, and the metallurgical requirements to cast products of desired quality. This latest edition improves upon the multitude of tolerances specified within the Engineering Series by providing examples for tolerance calculation, along with the addition of precision flatness tolerances for sand molds. The discontinuity level requirements specified in the Aluminum Casting Quality Standard has been updated. The edition also comprehensively builds upon the properties of Aluminum alloys relevant to casting today, including the addition of popular cast alloys such as A206. The publication includes the following standards: AA-CS-E1-92, AA-CS-E2-92, AA-CS-E3-92, AA-CS-E4-92, AA-CS-E5-92, AA-CS-E6-2000, AA-CS-E7-2000, AA-CS-E8-92, AA-CS-E9-92, AA-CS-E10-2000, AA-CS-E11-92, AA-CS-E12-92, AA-CS-E13-92, AA-CS-E14-92, AA-CS-E15-92, AA-CS-E16-2000, AA-CS-E18-92, AA-CS-E19-92, ,AA-CS-E20-92, AA-CS-E21-74, AA-CS-M1-85, AA-CS-M2-84, AA-CS-M3-2000, AA-CS-M4-84, AA-CS-M5-92, AA-CS-M5-85, AA-CS-M6-85, AA-CS-M7-85, AA-CS-M8-85, AA-CS-M9-74, AA-CS-M10-84 ,AA-CS-M11-85
Explains and illustrates many aspects of the published standard tolerances for aluminum alloy extrusions, such as those contained in the association's Aluminum Standards and Data. (56 pages)
The Tan Sheets list tempers for aluminum and aluminum alloy products, in metric units, registered with the Association by individual producers, which are not contained in Aluminum Standards and Data.
The 47-page metric counterpart of the Yellow Sheets, the Tan Sheets lists equivalent information in metric units based on the International System of Units (SI). The Tan Sheets list tempers for aluminum and aluminum alloy products registered with The Aluminum Association by individual producers, which are not contained in the Association's "Aluminum Standards and Data." Information on mechanical property data and other metallurgical characteristics specific to the alloy-temper combinations of numerous semi-fabricated products as well as a number of cast products that have been registered with The Aluminum Association are included. This document has been extensively revised to include numerous new registrations, revisions to the previously registered product information, and the deactivation of numerous obsolete products. Additionally, the temper registration procedures have been revised to clarify and expand on the registration rules and now include the criteria for registering press solution heat-treated materials as well as registration of products with tentative properties. NOTE: The US edition of this publication has also been revised. It is commonly called the "Yellow Sheets
This registration record is the defining source for the designations and chemical composition limits for wrought aluminum and wrought aluminum alloys referenced in a number of standards and specifications worldwide. The 2018 edition contains 20 new alloys and one newly inactive alloy.
This registration record is the defining source for the designations and chemical composition limits for wrought aluminum and wrought aluminum alloys referenced in a number of standards and specifications worldwide. New in this edition is information on 37 new alloy designations and 2 reactivated alloys, their associated chemical composition limits and nominal densities. Other information includes a list of previously registered but currently inactive alloy designations, chemical composition limits of inactive original alloys, the Declaration of Accord on an International Designation System for Wrought Aluminum and Wrought Aluminum Alloys and a list of the Signatories to the Accord.
This standard test procedure establishes criteria to determine the ability of a grain refiner to reduce grain size during solidification of aluminum alloys and to examine the structure of the grain refiner for uniformity and freedom from defects. Published in 2012.
Revised in 2007. Describes The Aluminum Associaton dissolution test procedure used to determine the suitability of an aluminum hardener product for alloying purposes. The test procedure describes a method for measuring dissolution time and recovery of the hardener element under standardized conditions. This method is not intended to predict dissolution rate or recovery under production conditions in commercial operations. (12 pgs.)
Describes how proper shipping, handling and storing procedures can minimize water staining. Covered are: causes of water stains; packaging recommendations; inspection procedures; and recommendations for the prevention of stains. A "Dew Point Calculator Table" is featured, showing under what conditions water will condense on metal, increasing the possibility of staining. Also included are lists of instrument suppliers, manufacturers of moisture indicating labels, and suppliers of water stain preventatives.
Describes how proper shipping, handling and storing procedures can minimize water staining. Covered are: causes of water stains; packaging recommendations; inspection procedures; and recommendations for the prevention of stains. A "Dew Point Calculator Table" is featured, showing under what conditions water will condense on metal, increasing the possibility of staining. Also included are lists of instrument suppliers, manufacturers of moisture indicating labels, and suppliers of water stain preventatives.
Describes procedures and methods that have been successfully used to handle sheet and plate in the plant, both manually and with the use of equipment. Covers storage, handling, processing and inspection. Now includes a list of suppliers of safety equipment and apparel. (18 pages)
Yellow Sheets list tempers for aluminum and aluminum alloy products registered with The Aluminum Association by individual producers, which are not contained in Aluminum Standards and Data.
The 44-page Yellow Sheets list tempers for aluminum and aluminum alloy products registered with The Aluminum Association by individual producers, which are not contained in the Association's "Aluminum Standards and Data." Information on mechanical property data and other metallurgical characteristics specific to the alloy-temper combinations of numerous semi-fabricated products as well as a number of cast products that have been registered with The Aluminum Association are included. This document has been extensively revised to include numerous new registrations, revisions to the previously registered product information, and the deactivation of numerous obsolete products. Additionally, the temper registration procedures have been revised to clarify and expand on the registration rules and now include the criteria for registering press solution heat-treated materials as well as registration of products with tentative properties.
Fully revised in May 2016 with extensive new and updated content. Outlines the steps, practices, and equipment used to reduce the potential hazards in management of molten aluminum throughout the charging, melting, transferring, and casting processes. New sections are included on casthouse mobile equipment, combustible dust, and aluminum-lithium activities. Significant revisions to the PPE guidance are also included. Industry research on the causes and prevention of molten aluminum incidents is provided along with historical incident trends in key areas. (109 pages)
Essential Information for Healthcare Providers Managing Medical IT-Networks
Specifies consensus terms relating to medical device servicing and repair.
This document is directed toward those who are responsible for electrical safety in healthcare facilities.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
Identifies the fundamental concepts and principles for creating, integrating, and implementing health IT software and health IT systems to maintain safety and effectiveness. (Provisional Standard)
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndrome.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how the specific features of the products that they offer comply with this standard or rationale as to why a specific provision might not apply to a particular product.
This standard defines a standard XML format for publishing and reporting the physical parameters of a C-Arm Radiation Therapy Linear Accelerator or the physical parameters in a software model of such a device.
The purpose of this guidance document is to help healthcare professionals prepare for an accrediting agency survey as it relates to the reprocessing of surgical instruments, endoscopes, and other reusable medical devices in any healthcare setting.
Introduces the reader to the basic principles of disinfection and sterilization science and then shows how this science is applied to develop and validate cleaning, disinfection, and sterilization processes.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices
Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed.
Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately; Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel; Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products; Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend
The AAMI TIR12 / ANSI/AAMI ST81 Set provides guidelines for designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers and ANSI/AAMI/ISO ST81:2004/(R)2010, Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices. AAMI TIR12 / ANSI/AAMI ST81 Set includes: AAMI TIR12:2010 ANSI/AAMI ST81:2004 (R2010)
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annex. Redline version notes changes from 2004 edition.
This AAMI Technical Information Report (TIR) provides additional guidance to augment ANSI/AAMI/IS0 11135, Medical devices-Validation and routine control of ethylene oxide sterilization for both medical device manufacturers that use contract sterilization facilities and contract sterilization operations. The TIR addresses how ANSI/AAMI/ISO 11135 applies to ethylene oxide sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135-1:2007 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135-1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence. Additional guidance on ANSI/AAMI/ISO 11135-1:2007 can be found in ANSI/AAMI/ISO 11135-2:2008.
This AAMI TIR provides additional guidance to augment ANSI/AAMI/ISO 11135û1:2007. This TIR addresses some of the physical aspects of ethylene oxide (EO) sterilization and provides guidance on sterilization equipment, considerations for preconditioning, how to calculate relative humidity, EO concentration, and flammability, as well as guidance on the use of statistics for process equivalence..
This technical information report (TIR) provides additional guidance to augment the ANSI/AAMI/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.
This technical information report (TIR) addresses various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process. It does not cover the various factors that can have an effect on the bioburden of the product and on the sterilization process. This TIR provides additional guidance to ANSI/AAMI/ISO11135-1:2007 and ANSI/AAMI/ISO TIR11135-2:2008 for medical device manufacturers, including those that use contract sterilization facilities or contract sterilization operations. Although the information presented was developed for application to medical devices, the content of this guideline may also be applied to other relevant products or materials.