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YY 0828-2011: ECG cables and leadwires
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ECG cables and leadwires
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YY 0828-2011
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Basic data | Standard ID | YY 0828-2011 (YY0828-2011) | | Description (Translated English) | ECG cables and leadwires | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 10.040.55 | | Word Count Estimation | 24,216 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | YY 1079-2008; ANSI/AAMI ES1-1993 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to YY 1079-2008 "ECG" defined by the standard ECG used for surface ECG (ECG) monitoring cables and patient leadwires. | YY 0828-2011: ECG cables and leadwires---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.
ECG cables and leadwires
ICS 10.040.55
C39
People's Republic of China pharmaceutical industry standards
ECG cables and lead wires
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 requires 2
Test Method 5 6
Appendix A (informative) introduced the basic reason of this standard 13
Annex B (informative) recommendations for ECG cables and lead wires 16 of the structural requirements
References 19
Figure 1 leads - leads (pair) dielectric strength test circuit (see 4.5.1 and 5.5.1) 7
Figure 2 leads - shield dielectric strength test circuit (see 4.5.1 and 5.5.1) 8
3 internal - external conductor dielectric strength test circuit (the course of a conductive material is exposed when using connection ① out; patients
When using unshielded connectors for connecting terminal ②) 8
4 sink current test circuit 8
Figure 5 Defibrillation Protection 9
Test noise measurement apparatus of FIG. 6 cable 9
7 bending life test set 10
B.1 connection 16 patients unshielded lead wires and the cable junction box between FIG.
Connection diagram B.2 shielded patient lead wires and the cable junction box between 17
Table 1 Device connectors, cable distributor, patient lead wire connector and flex life in patients with terminal tail curved net 4
Table 2 Tensile strength cable connection 4
Table 3 Connector Insertion/Removal number 5
Table 4 Patients with lead wire resistance 5
Foreword
This standard is not equivalent to the American National Standard ANSI/AAMIEC 53.1995 A1.1998 "ECG cables and lead wires."
This standard was proposed by the State Food and Drug Administration.
This standard by the National Standardization Medical Electrical Medical Electronic Instrument Standardization Technical Committee Technical Committee (SAC/TC10/SC5)
Centralized.
This standard was drafted. Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shanghai Medical Device detection.
The main drafters of this specific standard. Caojian Fang, Zhang Yi Dong, Shi Wenli, Zhang Xu.
Introduction
ECG monitoring equipment is widely used in clinical practice, design and patient safety and clinical effect of interest income and lead cable lines with its use
Off, and the country is not yet relevant standards. In order to ensure safe and effective products, while facilitating and international standards, this standard is not equivalent
ANSI/AAMIEC 53.1995 A1.1998, according to the mandatory implementation of industry standards.
The standard American Standard ANSI/AAMIEC 53.1995 A1.1998 the following changes were made.
--- To clarify the scope of the standard, the standard Chinese name changed to "ECG cables and lead wires";
--- Because of the actual situation, necessary and reasonable ECG cables and lead wires live longer than the original estimate AAMI standards, using
Frequency significantly higher than the estimate AAMI standard benchmarks. Determined according to the actual situation, a corresponding increase in ECG cables and leads
Line and the number of plug test durability and cleaning, sterilization cycles;
--- ANSI/AAMIEC 53.1995 A1. The 1998 Construction Requirements section is not conducive to innovation and product miniaturization trend, and
Currently interchangeability of different manufacturers ECG cable between whether the United States, other countries in the international arena, China has failed to achieve,
The section as a recommendation into Annex B;
--- Given standard recommended cables and lead wires durability test swing frequency;
Cables tensile strength of the force standard duration --- clear;
--- Remove ANSI/AAMIEC 53.1995 A1.1998 cover, foreword and introduction.
ECG cables and lead wires
1 Scope
Body surface ECG This standard applies to YY 1079-2008 "ECG" defined by the standard ECG used
(ECG) monitoring of patients with cables and lead wires.
1.1 Standard equipment includes
This standard includes a guide-line of disposable and reusable lead wires, some of the sections of this standard applies to two types of lead wires, which
Certain sections apply to only one type of lead wire (in the following manner in the corresponding chapter after chapter titles marked Scope. "Applies
Leads to two types of line "," suitable for disposable lead wires "or" suitable for reusable lead line ").
The standard test is for manufacturers to verify whether their products comply with the following safety and performance specifications and design. Above tests
Should not be performed by the end user device.
The standard cable in Appendix B to the junction box and the lead wire connector recommended a safe (no exposed metal pins), common
interface.
1.2 This standard does not include equipment
ECG cables and lead wires may be used in applications that require special performance, such as ambulance ECG equipment, telemetry equipment, operating room
And cardiac catheterization lab etc is not the scope of this standard. In addition to ECG monitoring function, this standard includes cables and lead wires patient
It can also support other functions such as impedance respiration monitoring. Unless otherwise specified, the patient cable and lead wires must comply with all of the standard
Claim.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member, undated references, the latest edition (including any amendments) applies to this document.
YY 1079-2008 ECG
ANSI/AAMIES1.1993 Medical Device Safety current limit (Safecurrentlimitsforelectromedicalapparatus)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Cable Assemblies cableassembly
For patient connected to ECG by a plurality of individual wires and/or beam components into the wiring harness inside a jacket. through
Typically, the cable assembly consists of a main cable and a set of patient leads lines. Lead wire may be separated from the main cable or main cable together constitute
A cable assembly (integrated cable and lead wire assembly).
3.2
Cable distributor cableyoke
Located at one end of the main cable, lead wires for patient access.
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