YY/T 0285.6-2020 Translated English of Chinese Standard. (YYT0285.6-2020): Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted portshttps://www.chinesestandard.net, 06.03.2022 - 29 Seiten This Part of YY/T 0285 specifies the relevant performance and safety requirements for sterile and single-use subcutaneous implanted ports. This Part applies to the subcutaneous implanted ports intended for long-term or persistent intravascular use, consisting of a subcutaneously implanted infusion port and catheter. |
Inhalt
| 3 | |
Annex A Normative Test method for no gas leakage | 14 |
Normative Test method for no leakage after multiple punctures | 20 |
Figure G 2 Bending test system | 27 |
Häufige Begriffe und Wortgruppen
Annex F bacterial endotoxin bending test tool Buchner funnel carried out according Central venous catheters colored solution compatibility for surgical Connect the catheter E.1 in YY effective surface area ethylene oxide F of YY Figure G.1 filter paper flushing volume following information GB/T given in Annex graduated cylinder Identification of subcutaneous implanted port according Intravascular catheters locking device Magnetic resonance compatibility magnetostrictive manufacturer manufacturer's instructions medical devices meet the requirements method given needle seat non-coring needle number of punctures outlet tube Patent Blue penetration and extraction ports and catheters power injection priming volume Puncture chips report shall contain report The test requirements of YY septum silicone rubber elastic single-use catheters Spectrophotometer split catheter Sterile and single-use Sterilization of health subcutaneous implanted port surgical implant Syringe test catheter component test in accordance test instrument test is carried Test method test report test solution tested according testing machine validation and routine YY/T