HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1287.3-2016 English PDF

US$219.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1287.3-2016: Intracranial external drainage system. Part 3: Intracranial external drainage catheter
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1287.3-2016English219 Add to Cart 3 days [Need to translate] Intracranial external drainage system. Part 3: Intracranial external drainage catheter Valid YY/T 1287.3-2016

PDF similar to YY/T 1287.3-2016


Standard similar to YY/T 1287.3-2016

YY/T 1437   YY/T 1292.4   YY/T 1465.2   YY/T 1287.2   YY/T 1292.3   YY/T 1287.1   

Basic data

Standard ID YY/T 1287.3-2016 (YY/T1287.3-2016)
Description (Translated English) Intracranial external drainage system. Part 3: Intracranial external drainage catheter
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.40
Word Count Estimation 11,145
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB/T 1962; GB/T 14233.2; GB/T 15812.1-2005; GB/T 16886.1; YY 0334; YY/T 0466.1; YY/T 0586; YY/T 0615.1; YY/T 1287.1; YY/T 1287.2; ISO 11607-1-2006
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements for craniocerebral drainage catheters (hereinafter referred to as drainage catheters) intended for use in craniocerebral puncture and lumbar puncture in the extracranial tract drainage system to ensure safe and effective use in the extracranial drainage system. Guidance devices and puncture devices in the craniofacial drainage system are not included in this standard.

YY/T 1287.3-2016: Intracranial external drainage system. Part 3: Intracranial external drainage catheter


---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 ICS 11.040.40 C30 People's Republic of China Pharmaceutical Industry Standard Extracranial drainage system Part 3. Extracranial drainage catheters Part 3. Intracranialexternaldrainagecatheter 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

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. 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. Wan Min, Li Kefang, Li Zhipeng, Yi Ying, Wang Jinhong, Han Wenkun, Zhang Haijun, Du Lanping.

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 article Pieces. 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. 3.1 Patient end patientend The drainage catheter is inserted into the forefront of the patient. 3.2 Use state condition forusing The craniocerebral drainage catheter was placed in the final condition for the patient for at least 24 hours after the (23 ± 2) ° C test conditions. If the product With a separate fastening device, a separate connector or a guiding device, the guide device is operated from the catheter (placed At least 24 hours after the removal of the separation device and/or the separation of the connector after the state.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1287.3-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1287.3-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1287.3-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1287.3-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.