YY/T 1287.3-2016Intracranial external drainage system - Part 3: Intracranial external drainage catheter (English PDF)

Foreword

YY/T 1287 "craniocerebral drainage system" is divided into three parts. Part 1. Brain drainage device for craniocerebral puncture;

- Part 2. Lumbar puncture cerebrospinal fluid drainage collection device; Part 3. Extracranial drainage catheters. This part is part 3 of YY/T 1287.

This part is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

Intracranial fluid (including cerebrospinal fluid, cerebral hemorrhage, hematoma), brain cyst fluid and so on. Cerebrospinal fluid is in the ventricle and connected with the spinal canal Of the liquid, the clinical can be as appropriate through the body shunt to other parts of the body, but also as the case through the ventricle drainage (belonging to Extracranial extracranial drainage) or lumbar puncture outside the way of drainage will be derived from the body. Cerebral hemorrhage other than cerebrospinal fluid can be punctured by brain Drain the way to drain to the outside.

Craniocerebral drainage catheter according to puncture, drainage of different parts of the fluid is divided into cranial puncture and external lumbar puncture external drainage catheter Two categories.

Craniocerebral puncture and external drainage catheter drainage according to the different brain fluid is divided into two categories, one can be inserted into the ventricle (craniotomy)

Drainage of cerebrospinal fluid (CSF) drainage catheter, that is, craniocerebral cerebrospinal fluid drainage catheter; one can be inserted into the brain epidural, subdural or brain Internal and other (craniotomy) drainage in addition to cerebrospinal fluid outside the brain fluid drainage catheter, that is, craniocerebral non-cerebrospinal fluid drainage catheter. Extracranial drainage system Part 3. Extracranial drainage catheters

1 Scope

This part of YY/T 1287 specifies the extracorporeal drainage catheter intended for craniocerebral lumbar puncture and lumbar puncture in the extracranial drainage system (Hereinafter referred to as drainage catheter) requirements to ensure its use in the extracranial drainage system is safe and effective.

Guidance devices and puncture devices in the craniofacial drainage system are not included in this section.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 1962 syringes, syringes and other medical devices 6% (Ruhr) conical joints

GB/T 14233.2 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 2. Biological test methods Non - vascular catheters - Part 1. General performance test methods GB/T 15812.1-2005

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management General requirements for silicone rubber surgical implants YY 0334

YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements Test method for X - ray impermeability of medical polymer products YY/T 0586

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for final sterilization of medical devices

YY/T 1287.1 Extracranial drainage system Part 1. Brain drainage device for craniocerebral puncture

YY/T 1287.2 Extracranial drainage system Part 2. Lumbar puncture Cerebrospinal fluid drainage collection device

ISO 11607-1.:2006 Packaging of final sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems 1) (Packagingforterminalysterilized medical devices-Part 1. Requirementsfor materials, sterile barriersystemsandpackagingsystems)

1) ISO 11607-1.:2006 equivalent to our standard GB/T 19633.1 is currently in the approval stage.

3 Terms and definitions

YY/T 1287.1, YY/T 1287.2 and the following terms and definitions apply to this document.