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5.1 The user-level calibration process may be used to verify that the DF tester is functioning properly, that it is within manufacturer specifications, and to perform minor adjustments to bring the unit back into conformance with manufacturer specifications.5.2 The DF tester user-level calibration described herein does not eliminate all error sources, nor does it guarantee the proper operation of the device. Several adjustments and repairs are beyond the scope of this standard, and manufacturer-approved calibrations are still recommended on an annual basis.1.1 This test method describes the equipment and procedure to ensure that the calibration performed by various dynamic friction tester (DF tester) users is uniform and in accordance with manufacturer specifications. There are three models of the DF tester in use: (1) USB/personal computer, (2) controller, and (3) X-Y plotter. Procedures specific to the different models are noted. User-level calibration software is separate from the operation software and must be obtained from the manufacturer for the USB/personal computer model.1.2 This test method is a static calibration of the vertical load, friction (µ) force, and speed of the DF tester. Compliance to this user-level calibration procedure ensures a higher level of repeatable and reproducible performance of the DF tester when used in accordance with Test Method E1911.1.3 The user-level calibration doesn’t include the replacement of the mu spring or the adjustment of linearity of the DF tester. It is recommended that DF testers be inspected by a manufacturer-approved laboratory on an annual basis to replace the mu spring, ensure linearity, and to identify other non user-serviceable wear.1.4 The values stated in SI (metric) units are to be regarded as standard. The inch-pound equivalents are rationalized, rather than exact mathematical conversions.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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Preface This is the first edition of CSA A344.1, User guide for steel storage racks, and CSA A344.2, Standard for the design and construction of steel storage racks. These Standards, in conjunction with CSA B335, establish the requirements for a saf

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This PDF includes Update No. 1 Preface This is the fourth edition of CSA A440.2/A440.3, Energy performance of windows and other fenestration systems/User guide to CSA A440.2-04, Energy performance of windows and other fenestration systems. It superse

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4.1 This guide has three purposes:4.1.1 To serve as a guide for developers of computer software that provides or makes use of authentication and authorization processes,4.1.2 To serve as a guide to healthcare providers who are implementing authentication and authorization mechanisms, and4.1.3 To be a consensus standard on the design, implementation, and use of authentication and authorization mechanisms.4.2 Additional standards will define interoperable protocols and message formats that can be used to implement these mechanisms in a distributed environment, using specific commercial technologies such as digital signatures.1.1 This guide covers mechanisms that may be used to authenticate healthcare information (both administrative and clinical) users to computer systems, as well as mechanisms to authorize particular actions by users. These actions may include access to healthcare information documents, as well as specific operations on those documents (for example, review by a physician).1.2 This guide addresses both centralized and distributed environments, by defining the requirements that a single system shall meet and the kinds of information which shall be transmitted between systems to provide distributed authentication and authorization services.1.3 This guide addresses the technical specifications for how to perform user authentication and authorization. The actual definition of who can access what is based on organizational policy.

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1.1 Scope IEC 60825-1 is applicable to safety of laser products. For convenience it is divided into three separate sections: Section One (General) and the annexes; Section Two (Manufacturing requirements); and Section Three (User's guide ). A laser

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Update #2 was published as notification that this is now a National Standard of Canada This PDF includes Update #2 A440-00 Windows 1. Scope 1.1 This Standard applies to both fixed and operable windows that are factoryand intended for vertic

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Information technology - Multimedia content description interface - Part 5: Multimedia description schemes AMENDMENT 2: Multimedia description schemes user preference extensions

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4.1 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types.3 At present label design and layout is developed by a given manufacturer and represents balancing internal needs (such as manufacturing, distribution, and marketing), regulatory requirements within various markets, and end user needs (as identified by individual manufacturers performing “voice of the consumer” feedback on their label designs).4.2 At no fault to any given manufacturer, this process, along with the manner in which label information competes for available “real estate” on a package, often leads to variable prioritization of label information and highly variable label designs. The impact of this variability on patient care is not well documented within the published literature. An article from AAOS Now in 2009 described potential issues around label variability and gave anecdotal evidence of its impact.34.3 No published literature demonstrating a clear and conclusive impact on patient safety resulting from implant label variability was identified. Despite this lack of evidence, anecdotal observations and input from various involved individuals and organizations (surgeons, operating room nurses, hospital administrators, product representatives, and manufacturers) suggests a potential, although unproven, benefit for an increased standardization of implant labeling.4.4 The authors of this guide believe it is important to highlight that no universally accepted method for validation of a label’s effectiveness exists. Current validation methods consist of varying methods of customer feedback on an existing label design using formal customer questionnaires, informal customer feedback through individual polling, and internal manufacturer-driven studies. The label recommendations presented within this guide have not been validated as more or less effective than other existing implant labels currently in use.4.5 These recommendations have been developed through the collaboration of an ASTM-sponsored task group with representation from large and small orthopedic implant manufacturers, orthopedic surgeons (specifically the Biomedical Engineering Committee from the American Academy of Orthopedic Surgeons), healthcare facility administrators, operating room nurses, the U.S. Food and Drug Administration (FDA), and the Canadian Healthcare System. The task group utilized “voice of consumer” feedback from previous manufacturer label initiatives combined with input from various end users on the task group. This process did not identify any given implant label format as being more or less effective but only attempts to prioritize information and recommend a universal format for this information. A manufacturer may determine that an alternative format may be more effective for its internal processes and elect not to follow these recommendations.1.1 The goal of this guide is to recommend a universal label format (across manufacturers and various implants) of content and relative location of information necessary for final implant selection within an implant’s overall package labeling.1.2 This guide recommends package labeling for musculoskeletal based implants individually processed and packaged with the intent of being opened at the point of use, typically in the operating room.1.3 This guide identifies the necessary, “high priority” label content and recommendations for the layout and location of information for accurate implant identification by the end users in the operating room environment.1.4 This goal is achieved by creating a partitioned, secondary area of an implant’s package label or a separate label to present this information uniformly.1.5 The authors of this guide identified the competing needs of regulatory requirements, manufacturing/distribution, and implant identification. It is recognized through our task group’s efforts that, if a manufacturer elects to implement these recommendations, balancing these competing needs may necessitate changing a manufacturer’s internal processes, relabeling their entire inventory (either at a single point in time or over a defined time period), or accepting duplicate information on an implant’s package label. No additional compromises that would allow the primary goal of uniform implant label design across manufacturers were identified.1.6 It is not the intent of this guide to limit or dictate overall package labeling content.1.7 It is not the intent of this guide to supplant existing regulatory requirements (only to augment or complement existing regulatory label requirements).1.8 The use or application of multiple languages is not prevented by this guide; however, use of more than one language is discouraged on the implant selection sublabel (ISSL) defined in this guide. The language of choice is left to the manufacturer and should be dictated by the end user and regulatory requirements in the jurisdictions where the device is marketed. International symbols should also be considered to avoid the need for multiple ISSLs where possible.1.9 Use and implementation of this guide is optional and at the sole discretion of the implant’s manufacturer. It shall be implemented with the following considerations:1.9.1 The content and layout of any orthopedic implant label should be influenced by risk management activities and all label formats should be validated.1.9.2 If internal risk management activities recommend deviation from this guide, the manufacturer is discouraged from implementing a hybrid label that partially applies the principles and recommendations in this guide.1.10 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.11 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.1.12 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 There are several live animal or carcass evaluation devices or systems used or under development for use in determination of economic value of live animals, carcasses, or individual cuts of meat. The correct use of these devices or systems may affect the reliability of the data.4.2 This practice provides user requirements for installation, operator training, operation, verification, inspection, maintenance, and retention of original data.1.1 This practice covers the requirements for users of livestock, meat, and poultry evaluation devices or systems used to measure and record composition or quality constituents of live animals, carcasses, and individual cuts of meat, when those devices or systems provide data that is used to determine economic value. Areas covered include: installation, operator training, operation, verification, inspection and maintenance of these evaluation devices or systems, and documentation of procedures for retention of original data.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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5.1 The objective of this specification is to facilitate identification of drugs in syringes filled by the user. The use of colors is intended only as an aid in identification of drug groups and does not absolve the user from the duty to read the label to correctly identify the drug prior to use.5.2 The user may alternatively use black and white labels rather than these colored labels.AbstractThis specification covers the size, color and pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer. The size and background color requirements of drug labels are presented in details. The type and color requirements of printing for drug labels are presented in details.1.1 This specification covers the size, color, pattern, and type used on labels applied to unlabeled syringes filled by the users or their agents to identify the drug content. This specification is not intended to cover labels applied by the drug manufacturer.FIG. 1 Standard Background Colors for User Applied Syringe Drug LabelsFIG. 2 Label for an Antagonist DrugFIG. 3 Reversed Plate Printing Used to Identify "SUCCINYLcholine," "EPINEPHrine," and Beta Blockers, "ESMOlol," "LABATolol," and "METOprolol"FIG. 4 Optional PrintingNote—Bold upper-case type is shown for first or first and second syllables of the drug name.FIG. 5 Drug Name and DosageFIG. 6 Alternative Label Showing Concentration in Percent and mg/mL1.2 The values stated in SI units are to be regarded as the recommended values. The use of inch-pound system values, not being exact equivalents, may result in nonconformance with the 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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