YY/T 1287.2-2016 English PDF

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YY/T 1287.2-2016: Intracranial external drainage system--Part 2: Collecting sets for external drainage by lumbar puncture
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1287.2-2016	279	Add to Cart	3 days	Intracranial external drainage system--Part 2: Collecting sets for external drainage by lumbar puncture	Valid

Similar standards

YY/T 1437   YY/T 1292.4   YY/T 1465.2   YY/T 1287.3   YY/T 1292.3   YY/T 1287.1   

Basic data

Standard ID: YY/T 1287.2-2016 (YY/T1287.2-2016)
Description (Translated English): Intracranial external drainage system--Part 2: Collecting sets for external drainage by lumbar puncture
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.40
Word Count Estimation: 14,164
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Intracranial external bus system - Part 2. Collecting sets for external drainage by lumbar puncture ICS 11.040.40 C30 People's Republic of China Pharmaceutical Industry Standard Extracranial drainage system - Part 2. Lumbar puncture Cerebrospinal fluid drainage device Part 2. Colectingsetsforexternaldrainagebylumbarpuncture 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 Structure and Naming 4.1 Structure 2 4.2 named 2 5 material 2 6 physical requirements 2 6.1 patient interface 2 6.2 Drainage piping 2 6.2.1 Transparency 2 6.2.2 Particulate contamination 2 6.2.3 Connection strength 2 6.2.4 Sealing 2 6.2.5 Anti-kink 3 6.2.6 Flow reduction rate 3 6.3 multi-channel switch 3 6.4 Dosing/Sampling Port 3 6.4.1 General 3 6.4.2 puncture connector 3 6.4.3 Needleless connector 3 6.5 drops of bottles (if any) 3 6.5.1 Appearance 3 6.5.2 dropper 3 6.5.3 Capacity and scale 3 6.5.4 Pressure indicator 3 6.6 intracranial pressure scale (if any) 4 6.6.1 scale unit 4 6.6.2 scale and indexing 4 6.6.3 zero reference line 4 6.6.4 Adjusting reliability 4 6.7 Collect container 4 6.7.1 Rated capacity 4 6.7.2 Falling leaks 4 6.7.3 Suspension reliability 4 6.7.4 drain 4 6.8 Exhaust filter 4 6.8.1 Filter integrity 4 6.8.2 Filter antibacterial 5 6.8.3 Filter hydrophobic or waterproof 5 6.9 protective cover 5 Chemical Requirements 5 Biology Requirements 5 8.1 Biocompatibility 5 8.2 Sterile 5 8.3 Bacterial endotoxin 5 9 type test 5 10 logo 5 10.1 single package 5 10.2 Outer packing 6 11 Packing 6 Appendix A (normative) Physical test method 7 Reference 10 Figure A.1 Schematic diagram of the test device Table 1 Drop bottle capacity and scale 3

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. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This part of the National Medical Pipeline Standardization Technical Committee (SAC/TC106) centralized. This part of the main drafting unit. Shandong Province, medical equipment product quality inspection center. This part participates in the drafting unit. Shandong Dazheng Medical Equipment Co., Ltd., Medtronic (Shanghai) Management Co., Ltd., Shandong Medical Equipment Co., Ltd., Weihai Shichuang Medical Technology Co., Ltd. The main drafters of this part are. Li Ming, Li Kefang, Li Yanping, Li Zhipeng, Wan Min, Han Wenkun, Zhang Haijun, Du Lanping.

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". Extracranial drainage system - Part 2. Lumbar puncture Cerebrospinal fluid drainage device

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 article Pieces. 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. 3.1 Lumbar puncture cerebrospinal fluid effusion CSFexternaldrainagebylumbarpuncture Through the lumbar puncture into the drainage catheter will be cerebrospinal fluid (CSF) drainage to the process of in vitro, also known as the waist pool continued external drainage. 3.2 Drain line The interface between the patient interface and the collection container inlet. Note. If the lumbar puncture cerebrospinal fluid drainage device is equipped with a drop bottle, the drainage pipe for the patient interface and the bottle between the bottle. ......

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