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NEPLATNÁ ASTM D6398-08(2014) 1.4.2014 náhľad

Doplňujúce informácie

ASTM D6398-08(2014)

Standard Practice to Enhance Identification of Drug Names on Labels (Withdrawn 2022)

Automaticky preložený názov:

Štandardné Practice pre zvýšenie Identifikácia drog mien na štítkoch

NORMA vydaná dňa 1.4.2014

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Dostupnosť	SKLADOM
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Informácie o norme:

Označenie normy: ASTM D6398-08(2014)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.4.2014
Kód tovaru: NS-34980
Počet strán: 3
Približná hmotnosť: 9 g (0.02 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM

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Anotácia textu normy ASTM D6398-08(2014) :

Keywords:

color contrasts, labeling, labels, legibility, ICS Number Code 11.120.10 (Medicaments),35.040 (Character sets and information coding)

Doplňujúce informácie

Significance and Use

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.

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.

2. Referenced Documents

ISO 3864	Safety Colors and Safety Signs Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
D4267-07	Standard Specification for Labels for Small-Volume (100 mL or Less) Parenteral Drug Containers
D996-23	Standard Terminology of Packaging and Distribution Environments
D7298-06(2017)	Standard Test Method for Measurement of Comparative Legibility by Means of Polarizing Filter Instrumentation
D4774-11	Standard Specification for User Applied Drug Labels in Anesthesiology
21 CFR 429.12	Packaging and Labeling of Insulin Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://www.dodssp.daps.mil.
21 CFR 201.66	Format and Content Requirements for Over-the-Counter (OTC) Drug Product Labeling