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YY/T 0492-2017 (YYT 0492-2017)

YY/T 0492-2017_English: PDF (YYT0492-2017)
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YY/T 0492-2017English439 Add to Cart 5 days Implantable cardiac pacing lead YY/T 0492-2017 Valid YY/T 0492-2017

BASIC DATA
Standard ID YY/T 0492-2017 (YY/T0492-2017)
Description (Translated English) Implantable cardiac pacing lead
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.40.040
Word Count Estimation 22,241
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Older Standard (superseded by this standard) YY/T 0492-2004
Drafting Organization Shanghai Medical Device Testing Institute
Administrative Organization National Medical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Technical Committee (SAC/TC 10/SC 5)
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 0492-2017
Implantable cardiac pacing lead
ICS 11.40.040
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0492-2004
Implantable cardiac pacemaker electrode lead
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 term 1
4 Technical requirements 2
4.1 Physical size 2
4.2 Appearance 3
4.3 Measurement of electrical characteristics of electrode wires 3
4.4 Protection against mechanical damage 6
4.5 Protection against temperature change damage 9
4.6 X-ray detectability 9
4.7 Accelerated aging life experiment 9
4.8 Chemical performance requirements 10
4.9 Sterilization 10
4.10 Protection against biological effects 11
4.11 Packaging, marking 12
4.12 Random File 13
Appendix A (Normative) Chemical Performance Test 15
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0492-2004 "Implanted cardiac pacemaker lead".
Compared with YY/T 0492-2004, the main changes of this standard are as follows.
--- Change the name of the standard to "Implanted cardiac pacemaker electrode lead";
--- Increased electrode lead pacing impedance and perceptual impedance requirements;
--- Increased the requirements for ray detectability;
---Modified the method of life test;
--- Modified the requirements for sterilization residues;
--- Increased particle release requirements;
--- Increased biological evaluation requirements for hemolysis;
--- Revised the requirements for random files with reference to the ISO 14708 series of standards.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is determined by the National Medical Electrical Apparatus Standardization Technical Committee Medical Electronic Instrument Standardization Subcommittee (SAC/TC10/SC5)
Return to the mouth.
This standard was drafted. Shanghai Medical Device Testing Institute.
The main drafters of this standard. Zhang Yidong, Xia Jie.
The previous versions of the standards replaced by this standard are.
---YY/T 0492-2004.
Implantable cardiac pacemaker electrode lead
1 Scope
This standard specifies the technical requirements, test methods and markings of implantable cardiac pacemaker electrode leads (hereinafter referred to as "electrode leads").
Packaging, transportation and storage requirements.
This standard applies to implantable cardiac pacemaker electrode leads. The characteristics of the electrode wire connector are YY/T 0491-2004 and
YY/T 0972-2016 (ISO 27186). This standard applies to a pacemaker system consisting of different electrode leads and pulse generators.
There is no requirement for functional compatibility or reliability.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
Preparation of GB/T 601 chemical reagent standard titration solution
GB/T 2423.22-2012 Environmental testing - Part 2. Test methods Test N. Temperature change (IEC 60068-2-14.
2009, IDT)
GB/T 7408-2005 Data element and exchange format information exchange date and time representation (ISO 8601.2000, IDT)
GB/T 16175-2008 Medical silicone material biological evaluation test method
GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
GB/T 16886.7 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residues (ISO 10993-7.1995, IDT)
GB/T 16886.18-2001 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005,
IDT)
GB 18279 Medical device ethylene oxide steri