YY/T 1287.1-2016 (English Version) PDF

Scope: This part of YY/T 1287 specifies the requirements for craniocerebral puncture external drainage collection devices in external cranial drainage systems, and is applicable to external ventricular drainage of cerebrospinal fluid and external drainage of cerebral hemorrhage (or hematoma). Requirements for devices for external lumbar puncture drainage, external cranial drainage catheters, and intracranial pressure monitoring equipment are outside the scope of this Part.

YY/T 1287.1-2016 Referenced Document

GB 8368-2005 Infusion sets for single use,gravity feed
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 17257.2-2009 Urine collection bags.Part 2:Requirements and test methods
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 0581.1-2011 Infusion access adapters.Part 1:Needle access adapters(Heparin plugs)
YY 0581.2-2011 Infusion access adapter.Part 2:Needleless access adapters
YY 0585.2-2005 Fluid lines for use with pressure infusion equipment and accessories for single use-Part 2:Accessories
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 0615.1 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices

2016 YY/T 1287.1-2016 Intracranial external drainage system.Part 1:Collecting sets for external drainage by intracranial puncture