YY/T 0282-2024 (YY/T 0282-2009) PDF EnglishUS$150.00 · In stock · Download in 9 seconds
YY/T 0282-2009: Syringe needle Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0282: Historical versions
YY/T 0282-2009: Syringe needle---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0282-2009YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.20 C 31 Replacing YY/T 0282-1995, YY 91019-1999, YY 91020-1999, YY/T 91140-1999 Syringe needle 注射针 Issued on: JUNE 16, 2009 Implemented on: OCTOBER 1, 2010 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 Introduction... 4 1 Scope... 5 2 Normative references... 5 3 Classification and marks... 5 4 Materials... 7 5 Requirements... 7 6 Marks, instructions for use... 10 7 Packaging... 11 8 Transport and storage... 11 Annex A (Informative) Guidelines for syringe needle use... 13 Annex B (Informative) Needle tip geometry and naming marks... 14 Annex C (Informative) Needle puncture force and test methods... 15 Annex D (Normative) Type inspection rules... 18 Syringe needle1 ScopeThis Standard specifies the requirements for injection liquid, vaccine, anesthetic or intravenous infusion, blood transfusion needles with nominal diameters of 0.4mm ~ 1.6mm, used for human body subcutaneous, intradermal, muscle, oral and other parts.2 Normative referencesThe provisions in following documents become the provisions of this Standard through reference in this Standard. For dated references, the subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard, however, parties who reach an agreement based on this Standard are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 191, Packaging and storage marks GB/T 1962.1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1.General requirement GB/T 1962.2, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2.Lock fittings GB/T 18457, Stainless steel needle tubing for the manufacture of medical devices3 Classification and marks3.1 Structure type The structure type and part name of syringe needle are shown in Figure 1. The specifications of syringe needle product are represented in nominal diameter of needle × needle tube length and wall type and edge angle. The needle tube sizes are in mm. Tube wall type. normal wall in RW, thin wall in TW Edge angle. long bevel angle in LB, short bevel angle in SB Marking example. A syringe needle with tube nominal outer diameter of 0.7 mm, tube length of 32 mm, short bevel angle, thin wall is marked as. 0.7 × 32 TW SB NOTE. When tube wall is normal and edge angle is long bevel angle, it shall not be marked.4 MaterialsThe materials used to make syringe needle shall meet the requirements in Clause 5.5 Requirements5.1 Needle seat 5.1.1 Needle seat conical connector shall be consistent with requirements of GB/T1962.1 or GB/T1962.2. 5.1.2 With normal or corrected vision observation, the outer surface of the needle seat shall be smooth; there shall be no cracks, defects; the coating shall not fall off; the mark shall be clear. 5.2 Needle tube 5.2.1 Rigidity When testing according to the method specified in GB/T 18457, the needle deflection value shall not exceed the provisions of Table 2. NOTE. Needle material can also be tested if necessary. d) volume (length × width × height); e) product registration certificate number, the implementation standard number; f) production lot number or production date; g) "fragile", "afraid of rain", "up" and other words or pictorial signs in line with the relevant provisions of GB/T 191. 6.2 Instructions for use There shall be at least the following information in the instructions for use. a) product name b) license number for medical device manufacturer, product registration certificate number and implementation standard number; c) scope of application, main structure and product performance; d) use methods, precautions; e) other instructions and necessary warning information; f) storage conditions.7 Packaging7.1 Small package materials and design shall ensure that the quality of built-in products is not compromised during normal storage and transport. 7.2 Each or several syringe needles shall be packed in a small package, with a certificate and instructions for use. NOTE. If medium-size packaging is used, the instructions for use shall be put into the package.8 Transport and storage8.1 Transport Syringe needle in the transport shall prevent heavy pressure, direct sunlight and rain and snow dip. 8.2 Storage b) pressure sensor measuring range. 0~50 N, accuracy of ± 0.5% (full scale). C.3 Simulated skin material The simulated skin material shall meet the following requirements. a) material. polyurethane film; b) thickness. 0.35mm ± 0.05mm; c) hardness. Shore A85 ± 10; d) exposed area. (after clamping) equal to Φ10 mm. C.4 Testing program The testing shall be carried out according to the following steps. a) place the testing needle and simulated skin at 22°C ± 2°C for at least 24 h and test at the same temperature; b) measure the device according to Figure C.1; clamp an appropriately dimensioned simulated skin c on the jig without any significant tensile or compressive forces on the simulated skin; c) install the testing needle on equipment a, its axis perpendicular to the plane of the simulated skin c and the tip pointing to the center of the circular puncture area; d) set the moving speed to 100 mm/min; e) start the testing device; f) during the puncture-on-membrane process, measure the maximum peak force. NOTE. Do not use punctured membranes that have been punctured in a circular puncture area. C.5 Conformity assessment When the maximum peak force measured is less than or equal to the value specified in Table C.1, the piercing force of the testing needle shall meet the requirements. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
