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Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0666-2008: Method for the test of sharpness and strength of needles tips Status: Obsolete
Basic dataStandard ID: YY 0666-2008 (YY0666-2008)Description (Translated English): Method for the test of sharpness and strength of needles tips Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C30 Classification of International Standard: 11.040.30 Word Count Estimation: 8,889 Date of Issue: 2008-10-17 Date of Implementation: 2010-06-01 Regulation (derived from): SFDA [2008] No. 605 Issuing agency(ies): State Food and Drug Administration Summary: This standard applies to medical suture needles, suture needles and acupuncture with needles (hereinafter referred to as the test pin) and other products of the tip sharpness and strength test method. YY 0666-2008: Method for the test of sharpness and strength of needles tips---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Method for the test of sharpness and strength of needles tips ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Tip sharpness and strength test Posted 2008-10-17 2010-06-01 implementation State Food and Drug Administration issued ForewordThis standard replaces GB 4506-1984 "tip sharpness and strength test methods." This standard compared with GB 4506-1984 The main changes are as follows. --- Application to make the appropriate adjustments, remove the needle tip sharpness and strength test methods; --- Scope increased with suture needle. The standard surgical instrument by the National Standardization Technical Committee and centralized. The standard medical suture needle by the Shanghai Co., Ltd. is responsible for drafting. The main drafters of this standard. Yuguo En, Jinyao Ming, Zhou Yaping. The standard standard replaces the previous editions. --- GB/T 4506-1984; --- WS2/Z-17-74. Tip sharpness and strength test1 ScopeThis standard applies to medical suture needle with suture needles and acupuncture needles (hereinafter referred to as the test pin) products such as needle sharpness and strength test Test methods. Principle 2 Piercing with a needle so that the measured force test device at a predetermined speed by a vertical aluminum foil is, the maximum peak force measured to evaluate the test needle Tip sharpness puncture force.3 Definitions3.1 After the tip loading force, the force of the hook does not appear. 3.2 Needle puncture force.4 test device4.1 shown in Figure 1, may also be used on other devices with the same performance, accuracy (including a printer, a floppy disk device, etc.). 1 --- Power switch; 2-4 --- Job control switch; 5 --- aluminum fixture; 6 --- needle clamp; 7 --- adjusting pendulum; 8 --- Level. Figure 1 Test Schematic ...... |
