Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: ASTM D4774-11(2017)
• Năm ban hành / Publication date: 2017
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Standard Specification for User Applied Drug Labels in Anesthesiology
• Chỉ số phân loại Quốc tế (ICS) / By field: 11.040.20 - Thiết bị truyền máu, tiêm truyền và tiêm
• Số trang / Page: 3

Phạm vi áp dụng / Scope of standard

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 Labels

FIG. 2 Label for an Antagonist Drug

FIG. 3 Reversed Plate Printing Used to Identify "SUCCINYLcholine," "EPINEPHrine," and Beta Blockers, "ESMOlol," "LABATolol," and "METOprolol"

FIG. 4 Optional Printing

Note-Bold upper-case type is shown for first or first and second syllables of the drug name.

FIG. 5 Drug Name and Dosage

FIG. 6 Alternative Label Showing Concentration in Percent and mg/mL

1.2 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.