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YY/T 0975-2016: Anaesthetic and respiratory equipment--User-applied labels for syringes containing drugs used during anaesthesia--Colours, design and performance
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YY/T 0975-2016	English	119	Add to Cart	3 days [Need to translate]	Anaesthetic and respiratory equipment--User-applied labels for syringes containing drugs used during anaesthesia--Colours, design and performance

YY/T 0975-2016: Anaesthetic and respiratory equipment--User-applied labels for syringes containing drugs used during anaesthesia--Colours, design and performance

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Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colors, design and performance ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Anesthesia and respiratory equipment during anesthesia for use in the containment The color, pattern and characteristics of the label on the drug syringe containingdrugsusedduringanaesthesia-color, designandperformance (ISO 26825..2008, MOD) 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard is modified using the international standard ISO 26825..2008 "Anesthesia and respiratory equipment during anesthesia for use in drug-containing syringes On the label color, pattern and characteristics "(English version). The technical differences between this standard and ISO 26825..2008 are as follows. --- modified the title of Chapter 3; --- 3.4.2 and Chapter 4 of ISO 26825..2008, which are amended to be included in the terms of 3.4.2 of this Standard, Chapter 4; --- in Figure 1 to Figure 5 in the English name of the label according to the Chinese Pharmacopoeia to Chinese name. This standard compares with ISO 26825..2008 with the following editorial changes. - the word "international standard" is changed to "this standard"; --- refers to the number with the decimal point symbol "." Instead of the symbol ","; --- Deleted the preface of ISO 26825..2008. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC116). The drafting of this standard. Shanghai Medical Devices Testing Institute. The main drafters of this standard. Chen Yijing, Li Min. Anesthesia and respiratory equipment during anesthesia for use in the containment The color, pattern and characteristics of the label on the drug syringe

1 Scope

This standard specifies the color, size, pattern and general characteristics of the label and specifies the printing characteristics of the drug name text. This standard applies to the label that the user affixes on the syringe so that the drug in the syringe can be identified before administration to the anesthesia. This standard does not apply to labels placed on a syringe or syringe by a manufacturer. Note. National or local regulations may require additional labeling, and the additional label may include a bar code, but its additional content is not covered by this standard. Note. The label color is used only to help identify different classes of drugs, but can not be exempted from the user before the need to read the label Content and confirmation of the duties of the drug.

2 Overview

2.1 The label shall be self-adhesive and shall be capable of withstanding the following tests. a) Attach the label to a 10 mL or 12 mL polyethylene syringe and allow for at least 12 h at a temperature of (23 ± 2) ° C. Note. polyethylene adhesive poor, can represent the most unfavorable situation, so the choice of polyethylene for the test syringe special materials. b) Immerse the syringe and label in an isopropyl alcohol solution at a volume of 50% for 5 min. c) After soaking, remove the syringe from the liquid, keep the syringe in a vertical state, and dry the air for 5 min. d) When the label is touched by hand, the label should not be displaced and should not be curled or raised at the edge. 2.2 If the label is in the form of tape, there should be perforations or marked markings between the labels. If the label has a back stick, then the label with the back Stickers and associated labels should be easily separated. 2.3 The material of the label should be suitable for the user to write additional information on the label (such as drug concentration), written with a ballpoint pen will not be blurred Or form a stain. 3 label color, size requirements 3.1 Overview It is recommended that the color, size and pattern of the label attached to the syringe or syringe by the manufacturer of the drug, and the transfer of the drug from the original container to The design of any label should be consistent with the provisions of this standard. 3.2 background color and pattern 3.2.1 The background color and pattern of the label shall comply with the requirements in Table 1. The background color of the label should not be too dark, otherwise it will affect the use of black circles The pen is written on the label to identify any additional information. 3.2.2 To label the opposite drugs (including antagonists), the background of the label should be of 1 mm wide, Stripes with 1mm wide white stripes (see Table 1). The stripes should extend from the lower left corner to the upper right corner and at an angle of 45 ± 5 ° with the long axis of the label. Drug name background and below the oblique stripes should be omitted (see 3.4.4 and Figure 1). 3.3 The size of the label The length of the label should be in the range of 25mm ~ 40mm, the width should be in the range of 10mm ~ 15mm. ...