This part of YY/T 1287 specifies the requirements for external cranial drainage catheters (hereinafter referred to as drainage catheters) intended for craniocerebral puncture and lumbar puncture in external cranial drainage systems to ensure their use in external cranial drainage systems. Safe and effective. Guiding instruments and puncture instruments in extracranial drainage systems are not included in the scope of this section.
YY/T 1287.3-2016 Referenced Document
GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 15812.1-2005 Catheters other than intravascular catheters-Part 1:Test methods for common properties
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
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
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY 0334 General specification for surgical implants made of silicone elastomer
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 0586 Medical polymer products-Test methods of radiopacity
YY/T 0615.1 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
YY/T 1287.1 Intracranial external drainage system.Part 1:Collecting sets for external drainage by intracranial puncture*， 2016-03-23 Update
YY/T 1287.2 External Cranial Drainage System Part 2: Lumbar Puncture Cerebrospinal Fluid External Drainage Collection Device