YY/T 1287.1-2016Intracranial external drainage system - Part 1: Collecting sets for external drainage by intracranial puncture (English PDF)

Foreword

YY/T 1287 "External Brain Drainage System" is divided into the following three parts.

--- Part 1. Brain puncture external drainage collection device;

--- Part 2. Lumbar puncture cerebrospinal fluid drainage device;

--- Part 3. Extracranial drainage catheter. This part is the first part of YY/T 1287.

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

Introduction

The extracranial drainage device is suitable for drainage of patients with cerebrospinal fluid and patients with less cerebral hemorrhage (or hematoma). Cerebrospinal fluid is in the brain The liquid in the spine that communicates with it can be clinically introduced into other parts of the body through shunting in the body, and can also be passed as appropriate.

Extracorporeal drainage (belonging to extracranial drainage) or extra-vertebral drainage leads it out of the body; cerebral hemorrhage (or blood outside the brain and under the skull)

Swelling can be taken out of the body by external drainage of the brain.

The device specified in this section is used for extraventricular drainage of the cerebrospinal fluid and external drainage of cerebral hemorrhage (or hematoma). The former needs ventricular pressure monitoring and Regulatory device.

For the in vivo shunt cerebrospinal fluid shunt, see YY/T 0487, "Single-use sterile hydrocephalus and its components." Extracranial drainage system Part 1. Brain puncture external drainage collection device

1 Scope

This part of YY/T 1287 specifies the requirements for the external drainage device for craniocerebral puncture in the extracranial drainage system. It is suitable for cerebrospinal fluid.

External drainage of the brain and external drainage of cerebral hemorrhage (or hematoma).

The requirements for devices for external drainage of the lumbar puncture, extracranial drainage catheters, and intracranial pressure monitoring devices are not within the scope of this section.

2 Normative references

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

GB/T 1962.2 Syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints (GB/T 1962.2-2001, ISO 594-2.:1998, IDT)

GB 8368-2005 Disposable infusion set gravity infusion (ISO 8536-4:2004, MOD)

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- 2011, ISO 10993-1.:2009, IDT)

GB 17257.2-2009 Urine collection bag Part 2. Requirements and test methods (ISO 8669-2:1996, IDT)

YY/T 0466.1 Medical devices for use in medical devices - signs, labels and symbols for information - Part 1. General requirements (YY/T 0466.1-2009, ISO 15223-1:2007, IDT)

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

YY 0581.2-2011 Infusion connection parts - Part 2. Needle-free connectors

YY 0585.2-2005 Disposable fluid circuits for pressure infusion devices and their accessories - Part 2. Accessories (ISO 8536-10. 2004, IDT)

YY/T 0615.1 Requirements for "sterile" medical devices - Part 1. Requirements for terminally sterilized medical devices

YY/T 1551 Air filtration material for infusion and blood transfusion apparatus

ISO 11607-1:2006 Packaging of terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems 1)

1) China's standard GB/T 19633.1 equivalent to ISO 11607-1:2006 is currently in the approval stage.

3 Terms and definitions

The following terms and definitions apply to this document.