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YY/T 1842.6-2022 English PDF

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YY/T 1842.6-2022: Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications
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YY/T 1842.6-2022English174 Add to Cart 3 days [Need to translate] Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications Valid YY/T 1842.6-2022

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Basic data

Standard ID YY/T 1842.6-2022 (YY/T1842.6-2022)
Description (Translated English) Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.25
Word Count Estimation 10,155
Date of Issue 2022-08-17
Date of Implementation 2023-09-01
Issuing agency(ies) State Drug Administration
Summary This standard specifies requirements for connectors recommended for use on the outlet end of a neurological application reservoir and on the inlet end of a neurological delivery device.

YY/T 1842.6-2022: Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications


---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.
ICS 11.040.25 CCSC30 People's Republic of China Pharmaceutical Industry Standard Connectors for the delivery system of medical liquid storage containers for medical devices Part 6.Neural Applications applications-Part 6.Neuralapplications Published on 2022-08-17 2023-09-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document is part 6 of YY/T 1842 "Connectors for Medical Devices and Medical Fluid Storage Container Delivery Systems". YY/T 1842 has The following sections have been published. --- Part 1.General requirements and general test methods; --- Part 6.Neurological applications; --- Part 7.Connectors for intravascular infusion; --- Part 8.Application of apheresis citrate anticoagulant. This document is equivalent to ISO 18250-6.2019 "Connectors for medical device medical fluid storage container delivery systems - Part 6.Neurological application". A chapter "Terms and Definitions" has been added to this document. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Infusion Devices (SAC/TC106). This document was drafted by. Shandong Institute of Medical Device and Drug Packaging Inspection, Henan Tuoren Medical Device Group Co., Ltd., Jinan Huanzheng Technology Development Co., Ltd., Beijing National Medical Equipment Huaguang Certification Co., Ltd. The main drafters of this document. Gao Na, Zhang Chong, Lu Wenbo, Ai Yingying, Fang Yuan, Zhang Lei.

Introduction

During the development of the ISO 80369 series of standards "Small Bore Connectors for Medical Liquids and Gases" it was found that the risk of incorrect connections is not limited to The connections to the patient, the connections for the reservoir portion at the end of the system also have a potentially high risk of wrong connections. for many reasons Since these reservoir connections are not suitable for the scope of application of the ISO 80369 series, it was decided to specially develop these reservoir connections. Issue a separate standard series. The 18250 series takes into account the risk of incorrect connection of reservoir connections in different applications, including in Standardized venous infusion sets specified in ISO 8536-4 and ISO 1135-4. Note. Even if there is no requirement in the current special standards related to medical devices, manufacturers are encouraged to apply the connectors specified in this document to medical devices. expect repair When ordering a special medical device standard, the dimensional requirements for connectors specified in this document will be included. YY/T 1842 "Connectors for Medical Liquid Storage Container Delivery Systems for Medical Devices" is intended to consist of the following parts. --- Part 1.General requirements and general test methods; --- Part 3.Gastrointestinal application; --- Part 6.Neurological applications; --- Part 7.Connectors for intravascular infusion; --- Part 8.Application of apheresis citrate anticoagulant. Connectors for the delivery system of medical liquid storage containers for medical devices Part 6.Neural Applications

1 Scope

This document specifies requirements for recommended connectors for use on the outlet end of a neurological application reservoir and on the inlet end of a neurological delivery device.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. ISO 18250-1 Connectors for medical device medical fluid storage container delivery systems - Part 1.General requirements and general test methods Note. YY/T 1842.1-2022 Connectors for medical device medical liquid storage container delivery systems - Part 1.General requirements and general test methods (ISO 18250-1.2018, IDT) ISO 80369-6 Small bore connectors for medical liquids and gases - Part 6.Connectors for shaft applications (Smal bore tions) Note. YY/T 0916.6-2022 Small bore connectors for medical liquids and gases Part 6.Connectors for shaft applications (ISO 80369-6.2016, IDT)

3 Terms and Definitions

Terms and definitions defined in ISO 18250-1 and ISO 80369-6 apply to this document.

4 Neural application reservoir outlet connector

4.1 The outlet end of the nerve application reservoir shall be a male axon locking connection (N2) in accordance with ISO 80369-6. 4.2 The connector should not be removed from the liquid container by the user.

5 Inlet connector of nerve drug delivery device

5.1 The inlet end of the nerve delivery device shall be a female axonal locking connection (N2) in accordance with ISO 80369-6. 5.2 The connector should not be removed from the drug delivery device by the user. Note. See Appendix A for relevant instructions, and Appendix B for the record of the analysis results of incorrect connections.

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