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YY/T 0491-2004 English PDF

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YY/T 0491-2004: Cardiac pacemakers. Low-profile connectors (IS-1) for implantable pacemakers
Status: Valid

Standard ID	Contents [version]	USD	STEP2	[PDF] delivered in	Standard Title (Description)	Status	PDF
YY/T 0491-2004	English	294	Add to Cart	3 days [Need to translate]	Cardiac pacemakers. Low-profile connectors (IS-1) for implantable pacemakers	Valid	YY/T 0491-2004

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Basic data

Standard ID	YY/T 0491-2004 (YY/T0491-2004)
Description (Translated English)	Cardiac pacemakers. Low-profile connectors (IS-1) for implantable pacemakers
Sector / Industry	Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C31
Classification of International Standard	11.040.40
Word Count Estimation	13,125
Date of Issue	2004-10-10
Date of Implementation	2005-09-01
Adopted Standard	ISO 5841-3-2000, IDT
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies for the implantable cardiac pacemaker electrode catheter connected to a pulse generator implanted cardiac pacemaker connector assembly, and provides basic dimensions, performance requirements and the corresponding test methods. Other plug performance, fastening methods and materials in this standard does not provide for, nor related to the different composition of the lead to the pacemaker pulse generator function of the system compatibility or reliability issues on various aspects.

YY/T 0491-2004: Cardiac pacemakers. Low-profile connectors (IS-1) for implantable pacemakers

---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.
Cardiac pacemakers.Low-profile connectors (IS-1) for implantable pacemakers ICS 11.040.40 C31 People's Republic of China Pharmaceutical Industry Standard YY/T 0491-2004/ISO 5841-3.2000 Cardiac pacemaker Small section connector for implantable cardiac pacemakers (ISO 5841-3.2000, Implantsforsurgery-Gardiacpacemakers- Part 3. Low-profileconnectors[IS-1]forimplantablepacemakers, IDT) Released on October 10,.2004 2005-09-01 implementation State Food and Drug Administration released

Foreword

This standard is equivalent to ISO 5841-3.2000 "Pacemakers -- Part 3. Small-section connections for implantable cardiac pacemakers 》. Appendix A of this standard is a normative appendix; Appendix B is an informative appendix. This standard is proposed and managed by the Technical Committee for Standardization of Medical Electronic Instruments of the National Medical Electrical Equipment Standardization Technical Committee. This standard was drafted. Shanghai Medical Device Testing Institute. The main drafters of this standard. Yu Hongjun, Zhong Zhizhen. YY/T 0491-2004/ISO 5841-3.2000

Introduction

Because clinicians are very concerned about the diversity of a variety of well-similar but incompatible small-section straight pacing leads, this is driven by this This part was developed (because these electrodes have an outer diameter of 3.2 mm, these connectors are often referred to as 3.2 mm leadses). This section The purpose is to specify a standard connector component, IS-1, that allows the lead and pulse generators produced by various manufacturers to be interchangeable. The safety, reliability and functionality of a particular connector is the responsibility of the manufacturer. Appendix A provides a test method for the impedance of the lead connector. Appendix B provides a description of the principle. It is recommended that you read Appendix B before using this section so that users can learn about its limited purpose. YY/T 0491-2004/ISO 5841-3.2000 Cardiac pacemaker Small section connector for implantable cardiac pacemakers

1 Scope

This standard specifies a connector set for connecting an implantable cardiac pacemaker lead to an implantable cardiac pacemaker pulse generator. And specify the basic dimensions, performance requirements and corresponding test methods. Other plug performance, fastening methods and materials in this standard No provision has been made, nor is it related to the functional compatibility or reliability of a different pacer and pulse generator to form a pacemaker system. Various aspects of the problem. If the implantable pulse generator can introduce a dangerous non-pacing signal (such as a defibrillation signal) through the IS-1 connector (see 4.3.3), then this standard The connector cavity specified by the standard is not applicable. This standard supplements GB 16174.1 and is only applicable to the requirements of the IS-1 connector component according to the identification instructions. Beater parts. This does not replace the various requirements specified in GB 16174.1. Note. Pace connector connectors that do not meet this standard may also be safe and reliable, and may have clinical advantages.

2 Normative references

The terms in the following documents become the terms of this standard by reference to this standard. All dated references, followed by all Modifications (not including errata content) or revisions do not apply to this standard, however, parties to agreements based on this standard are encouraged to study Is it possible to use the latest version of these files? For undated references, the latest edition applies to this standard. GB 16174.1-1996 Cardiac pacemakers - Part 1. Implantable cardiac pacemakers

3 definition

For the purposes of this standard, the definitions given in GB 16174.1 and the following definitions apply. 3.1 Includes a lead connector and a lumen with a connector for electrical and mechanical connection to the pulse generator Connected device. 3.2 A portion of the connector assembly that engages the lead. 3.3 A portion of the connector assembly that interfaces with the pulse generator. 3.4 An annular insulating layer that is electrically insulated between the electrical isolation components of the connector assembly when implanted. 3.5 YY/T 0491-2004/ISO 5841-3.2000

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