YY/T 1291-2016: Translated English of Chinese Standard. (YYT 1291-2016, YY/T1291-2016, YYT1291-2016): Single use subcutaneous infusion sets for use with insulin pump [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 2018/04/23 - 23 ページ
This Standard specifies the requirements for the subcutaneous infusion set for use with insulin pump that consists of interface, piping, piercing assembly. This product is a single use sterile product. This Standard does not include the requirements for insulin-filled devices (e.g., drug reservoirs, pre-filled cassette bottles) in insulin pumps.
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10N of axial 7000 to indicate According to A.3.1 and/or distributor's name apply 10N atmospheric pressure axial static tensile batch number blocking alarm threshold catheter assembly catheter base connector contain the substance distilled water volume effective length endotoxin ethylene oxide exceed flow reduction rate Flow V1 force for 15s given in YY/T graphic symbols given hypodermic needle insulin pump introducer needle unit isolation film kink layer if equipped leakage Locking device manufacturer and/or distributor's medical devices meet the requirements mm/min needle and catheter needle handle needle or catheter needle tip oblique insertion type output distilled water Peel strength pill volume pipeline pressure 20kPa higher protector if equipped puncture needle separate adhesive tape single use subcutaneous special socket protector specifies the requirements Standard static tensile force steel needle tubes subcutaneous infusion set substance of concern Test methods tested according trocar waterproof protective layer words of single words of sterile