YY 0881-2013: Translated English of Chinese Standard. YY0881-2013: Single-use Huber needles used for implantable drug-supplying devices
https://www.chinesestandard.net, 2017 M02 27 - 20 páginas
This Standard specifies the requirements for single-use Huber needles used for implantable drug-supplying devices (including infusion needles and hypodermic needles) to ensure the compatibility of implantable drug-supplying devices and infusion and injection devices.
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informative Relevant information on further evaluation of the quality
accordance with Clause address of manufacturer Annex bacterial endotoxin batch number bending angle catheter check valve Color coding comply with GB configuration connecting seat coordinate figure equivalent words evaluating the puncture F2 and F4 failure date Figure A.1 Figure C.2 GB/T given in YY/T graphic symbols given hose Huber hypodermic needle Huber infusion needle implantable drug-supplying device injection seat Leakage least the following length of needle lubricant manufacturer and/or distributor mark in accordance Medical Device meet the requirements method for evaluating mm/min needle handle needle is puncturing needle shall comply needle tubing axis needles for single nominal length nominal outer diameter peak force polymer film pressure infusion apparatus primary packaging product name protective cap protective cover puncture debris performance puncture forces puncture process pyrogen free rinse solution shown in Figure specification mark test method tested according type inspection type of Huber visual acuity word Batch words of single-use words of sterile