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Medical electrical equipment. Part 2; Particular requirements for the safety ofexternal cardiac pacemakers with internal power source
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Basic data
| Standard ID | YY 0945.2-2015 (YY0945.2-2015) |
| Description (Translated English) | Medical electrical equipment. Part 2; Particular requirements for the safety ofexternal cardiac pacemakers with internal power source |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard |
| Classification of Chinese Standard | C35 |
| Classification of International Standard | 11.040.01 |
| Word Count Estimation | 22,222 |
| Date of Issue | 2015-03-02 |
| Date of Implementation | 2017-01-01 |
| Adopted Standard | IEC 60601-2-31-1994+A1-1998, MOD |
| Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This Standard specifies requirements for the safety of external cardiac pacemakers with internal power supply. This Standard applies to the patient cable 2.1.104 defined. This Standard does not directly or indirectly connected to the device for the grid. This Standard does not apply to electrodes or other devices for cardiac pacing simulation: 1) become internal components with other functions of the device; or 2) the city of stimulation from the outside through the chest, or esophagus; or 3) in the high-speed pacing provide anti-tachycardia energy; or 4) provide pacing system analysis. Dual-chamber devices each chamber shall comply with the requirements of this standard. |
YY 0945.2-2015: Medical electrical equipment. Part 2; Particular requirements for the safety ofexternal cardiac pacemakers with internal power source
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Medical electrical equipment Part 2. Particular requirements for the safety of external cardiac pacemakers with internal power source
ICS 11.040.01
C35
People's Republic of China pharmaceutical industry standards
Medical electrical equipment - Part 2. with internal power supply
Requirements for the safety of external cardiac pacemakers
Medicalelectricalequipment-Part 2. Particularrequirementsforthesafetyof
(IEC 60601-2-31.1994 A1.1998, MOD)
Issued on. 2015-03-02
2017-01-01 implementation
China Food and Drug Administration released
Table of Contents
Preface Ⅰ
The first chapter Overview 1
1 Scope and purpose 1
2 Terms and definitions 2
5 Category 2
6 Identification, marking and documents 2
7 * 5 Input Power
The second environmental conditions 5
Third of the risk of electric shock protection 5
14 relevant for classification claim 5
19 Continuous leakage currents and patient auxiliary current 5
Title IV of mechanical hazard protection 6
The fifth chapter of unwanted or excessive radiation hazard protection 6
36 Electromagnetic compatibility * 6
Title VI of flammable anesthetic mixture ignition hazard protection 7
Title VII of the ultra-mild other security risk protection 7
44 overflow, liquid spill, leak, damp, into the liquid, cleaning, sterilization and disinfection 7
49 power supply interruption 7
7 accuracy and prevent the risk of output data of the eighth chapter of the work
7 50 Operating data accuracy
851 output to prevent dangerous
Chapter 9. abnormal operation and fault conditions; environmental testing 9
Tenth Canto structural requirements 9
56 components and subassemblies 9
Annex L (normative) Normative documents 11
Annex AA (informative) overall guidelines and guidance 12
Foreword
Medical electrical equipment standard series of standards, the series standard consists of two parts.
--- Part 1. General requirements for safety of medical electrical equipment;
--- Part 2. Medical electrical equipment requirements for the safety.
This section requirements for the safety of medical electrical equipment - Part 2 with internal power supply of external cardiac pacemakers. This part is
GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" changes and additions, this section takes precedence over the general requirements in
The corresponding provisions.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This section uses the translation method, modify the International Electrotechnical Commission standard IEC 60601-2-31.1994 A1.1998 "Medical electrical equipment
Preparation Part 2. external cardiac pacemakers with internal power source requirements for the safety. "
This part of IEC 60601-2-31.1994 A1.1998 main differences are as follows.
--- Remove the IEC 60601-2-31 standard introduction;
--- Remove the IEC 60601-2-31 standard informative annex BB;
--- IEC 60601-2-31 references in chapter 36 on the basis of standard IEC 801-2 has been updated to IEC 61000-4-2, this section by reference
Corresponding to the latest national standard GB/T 17626.2-2006;
--- Other international standards quoted in the standard, replace the corresponding international standard number conversion Ruoyi for our standard, then referenced relative
Should the national standard number, and indicate the relationship between the use of the Appendix L;
Provisions on the right edge of the asterisk "*" indicates that there is supplementary information in Annex AA.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Medical Electrical Medical Electronic Instrument Standardization Technical Committee of Standardization Technical Committee (SAC/TC10/SC5)
Centralized.
This section is drafted. Shanghai Medical Device detection.
The main drafters of this section. high school.
Medical electrical equipment - Part 2. with internal power supply
Requirements for the safety of external cardiac pacemakers
The first chapter outlines
Except as follows, common standards Benpian apply.
1 Scope and purpose
Except as follows, common standards in this chapter apply.
1.1 Scope
Addition.
The special provisions applicable to standard 2.1.101 defined external cardiac pacemakers with internal power requirements for the safety.
This standard applies to the patient cable 2.1.104 defined.
This standard does not directly or indirectly connected to the device for the grid.
This standard does not apply to the pacing electrodes or other devices for ECG simulation.
1) becomes the internal components with other functions of the device; or
2) stimulus from the outside through the chest, or esophagus; or
3) to provide anti-tachycardia pacing energy at high speed; or
4) provide pacing system analysis.
Each chamber dual-chamber device shall comply with the requirements of the standard.
1.2 Purpose
replace.
The specific standards for the purpose of the provisions of Security 2.1.101 requirements for defined external cardiac pacemaker.
1.3 Specific Standard
Addition.
This is a set of specific standard IEC Publication (hereinafter referred to as "General Standard" by GB 9706.1-2007, GB 9706.15-
2008, YY 0505-2012, YY 0708-2009 etc.) the amendments and additions.
For simplicity, GB 9706.1 in this specific standard is referred to as "General Standard" or "General requirements" and GB 9706.15,
YY 0505 YY 0708 are juxtaposed and standards.
The term "this Standard" covers this specific standard, which together with the General Standard and Collateral Standard.
The specific standards of each chapter, and all chapters of the number corresponding to the General Standard, General Standard for changes in the terms expressed by the following provisions.
"Replace" indicates that common standards chapter or completely replaced by the terms of this specific standard clauses;
"Supplement" means increased specific provisions of this standard for general requirements of the standard;
"Modify" means to press the special provisions of this Standard to the General Standard or modify the terms of Chapter.
General Standard for additional terms or FIG numbered starting from 101, additional annexes are numbered AA, BB, etc., additional items for the aa,
bb so on.
...
