1. Scope This International Standard establishes the principles and procedures for developing Type I environmental labelling p rogrammes, including the selection of product categories, product environmental criteria and product function characteristics

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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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5.1 Medication errors by users sometimes occur due to difficulty in reading or understanding drug container labels. The objective of this specification is to facilitate correct drug product identification. It does not absolve the user from the duty to read the label and correctly identify the drug product prior to use.AbstractThis specification covers the requirements for labels used for small-volume parenteral drug containers, in particular, the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers. The label shall contain the proprietary name of the drug (optional), established or generic name of the drug (required), amount of drug per unit, and, for liquids, the total volume of the contents-all of which shall be printed in conformity with the type size (as large as possible), orientation (parallel to the long axis of the container), and legibility (provide contrast between the type used for proprietary and established names of the drug and amount of drug per unit, and avoid the use of pastel shades for label background) requirements. Legibility test shall be performed to assess the conformance of the label with the requirements specified.1.1 This specification covers the orientation, the size of type used, and the contrast of the copy with the label background on immediate drug containers having a volume of 100 mL or less.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.

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1. Scope 1.1 The purpose of this Standard is to facilitate identification, by class, of drugs in syringes filled by the user that are used in anaesthesia and critical care. 1.2 This Standard specifies design requirements for the size, shape, patte

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4.1 Medication errors occur when users are confused by the similar size, shape, color, typeface, and layout of labels that are used for a range of a manufacturer's drugs with widely dissimilar actions or potencies. The human visual system uses shape, size, color, and typeface in the initial recognition of a labeled drug. (See 9.1 – 9.3.) The use of this human visual system has been described in 21 CFR 429.12 for the labeling of insulin. Using the similar label design, color, and typeface throughout a product line makes identifying an individual drug more difficult.4.2 The objective of this practice is to provide guidance for the design of drug labels which will enable users to easily distinguish between drugs of differing action or potency. See Note 1.Note 1—For specific requirements for these labels and other features of labels for OTC human drugs, see 21 CFR 201.66.1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers.1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers.1.2 This practice does not apply to over-the-counter drug product labeling.1.3 This practice does not apply to retail product labeling.1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.

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5.1 This practice is provided to develop and maintain uniformity in practices for use, selection, location, placement, and content of labels on treestands and climbing sticks, particularly with regard to quality assurance and safety.5.2 It is emphasized that the use of these practices will not alter the validity of data determined with specific tests, but provides guidance in the interpretation of test results (valid or invalid) and guidance in the selection of a reasonable general provision in those instances where no standard exists today.1.1 This practice provides guidance for providing user labels on treestands.1.2 The values stated in inch-pound units are to be regarded as standard. No other units 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 and health practices and determine the applicability of regulatory limitations prior to use.

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