YY/T 1287.2-2016Intracranial external drainage system - Part 2: Collecting sets for external drainage by lumbar puncture (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 2 of YY/T 1287.

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

Introduction

Cerebrospinal fluid is in the ventricle and interconnected with the liquid within the spinal canal, as the case may be through the body shunt to lead to the body Other parts, but also according to the situation through the ventricle drainage (belonging to the brain outside the drainage) or lumbar puncture outside the way to lead it in vitro.

This part of the device for the cerebrospinal fluid lumbar puncture external drainage, also known as the waist pool continued drainage.

In vivo diversion cerebrospinal fluid shunt see YY 0487 "disposable sterile hydrocephalus and its accessories".

1 Scope

This part of YY/T 1287 specifies the requirements for lumbar puncture cerebrospinal fluid drainage collection devices in the extracranial drainage system. Extracranial drainage catheters are not included in this section.

The requirements for intracranial pressure monitoring equipment are outside the scope of 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 8368 disposable infusion set gravity infusion type

GB/T 14233.2 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 2. Biological test methods

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management

YY/T 0466.1 Medical devices for medical device signs, labels and symbols for providing information

YY 0581.1-2011 Infusion connection Part 1. Piercing connector (heparin cap)

YY 0581.2-2011 Infusion connections - Part 2. Needle - free connectors Yiy0585.2-2005 Disposable liquid circuits and their accessories for pressure infusion sets - Part 2. Accessories

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

YY/T 1287.1-2016 Extracranial extracorporeal drainage system - Part 1. Brain drainage device for craniocerebral puncture

YY/T 1551.1 Air filters for infusion and transfusion apparatus - Part 1. Aerosol bacterial retention test method

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 1287.1-2016 and the following

terms and definitions apply to this document.