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YY 0885-2013: Medical electrical equipment-Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
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Medical electrical equipment-Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
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YY 0885-2013
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Basic data | Standard ID | YY 0885-2013 (YY0885-2013) | | Description (Translated English) | Medical electrical equipment-Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 34,341 | | Adopted Standard | IEC 60601-2-47-2001, MOD | | Regulation (derived from) | State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the special safety requirements apply to 2. 101 defined Holter system. Can give the same results when the tomb of a) continuous ECG recording and analysis system, and the system for a complete re-analysis of the ECG: The following | YY 0885-2013: Medical electrical equipment-Part 2: Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
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Medical electrical equipment-Part 2. Particular requirements for the safety, including essential performance of ambulatory electrocardiographic systems
ICS 11.040.55
C39
People's Republic of China pharmaceutical industry standards
Medical electrical equipment - Part 2.
Holter system safety and essential performance
Medicalelectricalequipment-Part 2. Particularrequirementsforthesafety,
(IEC 60601-2-47.2001, Medicalelectricalequipment-Part 2-47. Particular
requirementsforthesafety, includingessentialperformanceof
ambulatoryelectrocardiographicsystems, MOD)
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Table of Contents
Introduction Ⅲ
The first chapter Overview 1
1 Scope and purpose 1
2 Terms and definitions 2
5 Category 3
6 Identification, marking and documents 3
The second environmental conditions 4
10 4 environmental conditions
Third of the risk of electric shock protection 4
20 Dielectric strength 4
Title IV of the mechanical hazards Protection 5
21 Mechanical strength 5
The fifth chapter of unwanted or excessive radiation hazard protection 5
36 Electromagnetic compatibility * 5
Title VI of the danger of ignition of flammable anesthetic mixture Protection 6
Title VII of the ultra-mild other security risk protection 7
7 accuracy and prevent the risk of output data of the eighth chapter of the work
7 50 Operating data accuracy
1351 to prevent the risk of output
Chapter 9. abnormal operation and fault conditions; environmental testing 18
Tenth Canto structural requirements 18
56 components and assembly 18
Annex L (normative) Normative documents 23
Annex AA (informative) Theoretical and guidance 24
Conduction emission test apparatus of FIG. 101 (see this standard 36.201.1) 19
102 radiated emission and immunity test apparatus of FIG. (See this standard 36.201.1 and 36.201.2) 20
103 input dynamic range of the test signal (see 51.5.1 of this standard) 20
Figure 104 Universal Test circuit (see this standard 51.5) 21
The test circuit 105 common mode rejection (see 51.5.3 of this standard) 22
106 pacemaker pulse tolerance test circuit (see this standard 51.5.11) 22
Table 101 leads color code 3
Table 102 standard output analysis reporting requirements 8
Optional 103 sheet output analysis reporting requirements 8
Table 104 stroke - stroke alignment matrix 10
Foreword
Medical electrical equipment standard series of standards, the series standard consists of two parts.
--- Part 1. General requirements for medical electrical equipment safety;
--- Part 2. Safety requirements for medical electrical equipment.
The specific standard is "Medical electrical equipment - Part 2-47. Part 2 Medical electrical equipment. Holter system security and groups
This special performance requirements. " This is a specific standard GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety" of repair
Changes and additions to the specific standards take precedence over generic standards.
This dedicated drafting standards in accordance with GB/T 1.1-2009 given rules.
The use of specific standard redrafted law, amend the International Electrotechnical Commission standard IEC 60601-2-47.2001 "Medical Electrical Equipment
Part 2-47. Holter system safety and essential performance requirements "(in English).
This standard and IEC 60601-2-47.2001 main differences are.
--- IEC 60601-2-47.2001 in Chapter 36 is juxtaposed standard IEC 60601-1-2.1993 complements our current and electromagnetic
Compatibility YY 0505-2011 "Medical electrical equipment - Part 1-2. General requirements for safety - Collateral standard. Electromagnetic and
Capacity requirements and testing "identical with IEC 60601-1-2.2004. Thus, in this specific standard-setting process, technology standardization
Operation Committee believes that it is necessary to refer to the latest parallel standards, updates to electromagnetic compatibility requirements.
--- Other international standards quoted in the standard, if it has accordingly into our standards, places of reference standards prevail.
--- Remove IEC 60601-2-47.2001 Introduction, according to China's industry standards rewritten.
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.
The specific standard of medical equipment by the National Standardization Committee for Standardization Technical Committee of Medical Appliances (SAC/TC10/SC5)
And focal points.
The specific standard drafting units. Shanghai Medical Device Testing the Shanghai Food and Drug Administration certification assessment center.
The main drafters of this specific standard. Qian Hong, Xue Liang, Shi Wenli.
Medical electrical equipment - Part 2.
Safety and essential performance requirements for Holter System
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.
This standard specifies the special safety requirements applicable to specific definitions of 2.101 Holter system.
The following types of systems within the scope of this standard.
Gives basic when a) continuous ECG recording and analysis system, and the system for a complete re-analysis of ECG
The same results. The system can be recorded and stored electrocardiogram, and then in a separate unit for analysis or record
And analysis at the same time. This standard does not involve the use of the type of storage media;
b) to provide continuous analysis and partial or limited record, but not a complete re-ECG analysis system.
Meet any of these types of systems are applicable to the standard safety requirements.
If Holter ECG analysis system provides automated, the applicable minimum performance requirements of this standard of measurement and analysis functions.
By the GB 10793-2000 and GB 9706.25-2005 covered medical electrical equipment not within the scope of this standard.
This standard does not apply to the ECG can not be continuous recording and analysis system (for example, "intermittent event recorders").
1.2 Purpose
replace.
The specific standard is intended to develop specific requirements for Holter system safety and essential performance.
1.3 Specific Standard
Addition.
The specific reference standard GB 9706.1-2007.
It said in this specific standards in Part 1 of the "General Standard" or "General requirements."
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 provision.
"Supplement" means this specific standard provisions to increase the general standard.
"Modify" means to press the special provisions of this Standard to the General Standard or chapter shall be modified.
General Standard for additional terms or FIG numbered starting from 101, additional annexes are lettered as AA, BB, etc., increased column items
As aa), bb) and the like.
The term "this standard" is used to refer to the General Standard and this Particular Standard collectively.
When universal standard articles, chapters and bars without the corresponding articles, chapters and clauses in this specific standard, even may not be relevant, and no change to
Be applicable.
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