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YY 0828-2011ECG cables and lead wires (English PDF)

心电监护仪电缆和导联线

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

December 31, 2011

Implementation date

June 1, 2013

Scope

YY 0828-2011 is the English-translated version of 心电监护仪电缆和导联线.

YY 0828-2011 is the Chinese standard "ECG cables and lead wires". Its scope clause reads: 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. Its clauses include terms and definitions.

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Document preview — YY 0828-2011

National Standard of the People's Republic of China

ICS
10.040.55
Classification
C39

Issued by: National Medical Products Administration

Contents

  • Preface
  • Introduction
  • 1 Scope
  • 2 Normative references
  • 3 Terms and definitions
  • 4 requires
  • Appendix A (informative) introduced the basic reason of this standard
  • Annex B (informative) recommendations for ECG cables and lead wires 16 of the structural requirements
  • References
  • 4 sink current test circuit
  • 7 bending life test set

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 9 pages — is available in the English PDF.

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