|
US$1159.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 9706.247-2021: (Medical electrical equipment - Part 2-47: Specific requirements for basic safety and basic performance of Holter system)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 9706.247-2021 | English | 1159 |
Add to Cart
|
7 days [Need to translate]
|
(Medical electrical equipment - Part 2-47: Specific requirements for basic safety and basic performance of Holter system)
| Valid |
YY 9706.247-2021
|
PDF similar to YY 9706.247-2021
Basic data | Standard ID | YY 9706.247-2021 (YY9706.247-2021) | | Description (Translated English) | (Medical electrical equipment - Part 2-47: Specific requirements for basic safety and basic performance of Holter system) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C39 | | Word Count Estimation | 57,589 | | Issuing agency(ies) | State Drug Administration | YY 9706.247-2021: (Medical electrical equipment - Part 2-47: Specific requirements for basic safety and basic performance of Holter system)
---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.
(Medical electrical equipment Part 2-47.Specific requirements for basic safety and basic performance of Holter system)
ICS 11.040.55
C39
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0885-2013
Medical Electrical Equipment Part 2-47.
Basic Safety and Essential Performance of Holter Systems
Dedicated requirements
(IEC 60601-2-47.2012, MOD)
2021-09-06 Released 2024-05-01 Implementation
Released by the State Drug Administration
directory
Preface III
Introduction V
201.1 Scope, Purpose and Related Criteria1
201.2 Normative References 2
201.3 Terms and Definitions 2
201.4 General Requirements 4
201.5 General Requirements for ME EQUIPMENT Testing 5
201.6 Classification of ME EQUIPMENT and ME SYSTEM 5
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 5
201.8 ME EQUIPMENT PROTECTION FROM ELECTRIC SHOCK HAZARD7
201.9 Protection of me equipment and me systems against mechanical hazards 7
201.10 Protection against unwanted or excessive radiation hazards7
201.11 Protection against ultra-temperature and other hazards 7
201.12 Accuracy of controllers and instruments and protection of hazardous outputs 7
201.13 Hazardous situations and fault states 27
201.14 Programmable Medical Electrical System 27
201.15 Structure of ME equipment 27
201.16 ME System 28
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 28
202 Electromagnetic Compatibility --- Requirements and Tests 28
Appendix AA (Informative Appendix) Theory and Guidance 31
Reference 48
index 49
Generic Test Circuit 20 for Figures.201.101.201.12.4.4
Figure.201.102 Test signal 21 for input dynamic range test according to.201.12.4.4.101
Figure.201.103 Test circuit for testing common mode rejection according to.201.12.4.4.103 23
Figure.201.104 Test circuit for pacing pulse tolerance according to.201.12.4.4.109 26
Figure 202.101 Conducted emissions for 202.6.1.1.2, radiated emissions for 202.6.1.1.2 and 202.6.2.3.2, and radiated immunity
Test device 29
Table.201.101 Supplementary basic performance requirements 5
Table.201.102 Lead Color Code 6
Table.201.103 Requirements for all arrhythmia algorithms 9
Table.201.104 Algorithm requirements with optional features 10
Table.201.105 Classification of beat markers 14
Table.201.106 Example of calculation result of noise floor 16
Table.201.107 HRV Test Results Example 16
Table.201.108 Summary of Burst Sensitivity Matrix 17
Table.201.109 Summary of burst positive predictive value matrix 17
Table AA.1 Records used in the complete test32
Table AA.2 Tabulated beat-to-beat performance report example 35
Table AA.3 11 elements of the stroke-to-beat comparison summary matrix36
Table AA.4 Summary of beat-to-beat comparisons (matrix) 36
Table AA.5 Non-analytical interval tabular report example 37
Table AA.6 Tabular report example 38
Table AA.7 VF Report Example 38
Table AA.8 Fake VF report example 38
Table AA.9 Tabular Pair and Burst Report Example 39
Table AA.10 Comprehensive test mode example for equipment measurement 40
Table AA.11 Examples of ideal values predicted under the comprehensive test mode 40
Table AA.12 Test mode selection example 41
Table AA.13 Root Mean Square Example of Interval Difference 43
Table AA.14 Summary example of frequency components 44
foreword
All technical content of this part is mandatory.
"Medical Electrical Equipment" is divided into two parts.
--- Part 1.General and side-by-side requirements;
--- Part 2.Specific requirements.
This part is part 2-47.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0885-2013 "Medical Electrical Equipment Part 2.Special Requirements for Safety and Basic Performance of Holter Monitoring Systems"
Compared with YY 0885-2013, the main technical changes other than editorial changes are as follows.
--- Added normative references (see.201.2);
--- Added some terms and definitions (see.201.3.201,.201.3.205,.201.3.207~209,.201.3.214,.201.3.216~
224);
--- Modified the terms and definitions of "continuous recorder" and "playback device" (see.201.3.204,.201.3.215, 2.110 of the.2013 edition,
2.103);
--- Deleted the term and definition of "patient electrode" (see 2.106 of the.2013 edition);
--- Added general requirements (see.201.4);
--- Introduce the concept and requirements of basic performance (see.201.4.101);
--- Supplemented the classification of ME EQUIPMENT and ME SYSTEMS (see.201.6);
--- Supplemented ME EQUIPMENT identification, marking and documentation (see.201.7);
--- Added requirements for arrhythmia algorithm (see.201.12.1.101.1.5.2);
--- Supplement the requirements for algorithms with optional functions (see.201.12.1.101.1.5.3);
--- Added requirements for heart rate, heart rate variability or RR interval variability (see.201.12.1.101.2.3.3);
--- Added the requirement for segment-segment comparison (see.201.12.1.101.2.4);
--- Removed the requirement for the minimum detection signal (see 51.5.10 of the.2013 edition);
--- Added requirements for Programmable Medical Electrical Systems (PEMS) (see.201.14);
--- Revised the drop height requirement for drop test under working condition, from 75mm to 5cm (see.201.15.3.4.2,.2013 edition
21.5);
--- Increased the requirements for the ME system (see.201.16);
--- Deleted the requirements for dielectric strength (see 20 of the.2013 edition);
--- Increased electromagnetic compatibility requirements and tests for ME EQUIPMENT and ME SYSTEMS (see 202);
--- Added index of references and terms.
This section uses the redrafted method to modify and adopt IEC 60601-2-47.2012 "Medical Electrical Equipment Part 2-47.Holter
Particular requirements for basic safety and basic performance of systems.
The technical differences between this part and IEC 60601-2-47.2012 and their reasons are as follows.
--- Regarding normative reference documents, this part has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in the chapter "Normative References", and the specific adjustments are as follows.
● Added reference to GB 4824;
● Replacing IEC 60601-1-2.2007 with YY 9706.102 which has been modified to adopt the international standard.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5)
focal point.
This section is drafted by. Shanghai Optoelectronics Medical Electronic Instrument Co., Ltd., Shanghai Medical Device Testing Institute.
The main drafters of this section. Zhou Yuanyi, Yang Yongbin, Zhao Yang.
The previous versions of the standards replaced by this part are as follows.
---YY 0885-2013.
Introduction
This section deals with the basic safety and essential performance of the Holter monitor system. This part modifies and supplements GB 9706.1-2020 "Medical
Electrical equipment - Part 1.General requirements for basic safety and basic performance", hereinafter referred to as the general standard.
The requirements of this section take precedence over the general standard.
A "General Guidance and Rationale" for the more important requirements of this part is contained in Appendix AA.
In this section, the terms marked with an asterisk (*) are explained in Appendix AA.
We believe that understanding these requirements not only facilitates the correct application of this part, but also expedites timely due to changes in clinical practice or
The process of revising standards as technology evolves. However, Appendix AA is not part of the requirements of this section.
Medical Electrical Equipment Part 2-47.
Basic Safety and Essential Performance of Holter Systems
Dedicated requirements
201.1 Scope, Purpose and Related Standards
Clause 1 1) of the General Standard applies, except for the following.
1) The general standard refers to GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance".
201.1.1 Scope
replace.
This section specifies the specific requirements for the basic safety and basic performance of Holter monitoring systems.
This section applies to the basic safety and basic performance of the Holter electrocardiogram system (hereinafter referred to as the ME system).
If a chapter or an article applies only to ME EQUIPMENT or ME SYSTEM, the title and content of these chapters or articles will give a clear statement. Such as
If not stated, this clause or clause applies to both ME EQUIPMENT and ME SYSTEMS.
In addition to 7.2.13 and 8.4.1 of the general standard, inherent hazards to the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this part
harm is not covered by the specific requirements of this section.
NOTE. See General Criteria 4.2.
The following types of systems are within the scope of this section.
a) A system that continuously records and analyzes the electrocardiogram, and which gives the basic
Same result. The system can record and store ECGs for analysis in a separate unit, or record
concurrently with the analysis. This standard does not address the type of storage medium used.
b) Systems capable of providing continuous analysis and only partial or limited recording. The system cannot perform a complete reanalysis of the ECG.
Systems that meet any of the above types are applicable to the safety requirements of this section.
If the Holter monitoring system provides automatic ECG analysis, the minimum performance requirements for the measurement and analysis functions specified in this section apply.
By GB 9706.225 "Medical Electrical Equipment Part 2-25.Special Requirements for Basic Safety and Basic Performance of ECG Machines" and
Covered by GB 9706.227 "Medical Electrical Equipment Part 2-27.Special Requirements for Basic Safety and Basic Performance of ECG Monitoring Equipment"
Medical electrical equipment is not within the scope of this section.
This section does not apply to systems that cannot continuously record and analyze the ECG (eg, "intermittent event recorder").
201.1.2 Purpose
replace.
The purpose of this section is to specify specific requirements for the basic safety and essential performance of Holter monitoring systems.
201.1.3 Tied standards
Replenish.
This section refers to Chapter 2 of the General Standard and the applicable collateral standards listed in.201.2 of this section.
YY 9706.102 Section 202 as amended applies. GB 9706.103-2020, YY 9706.108-2021 and
IEC 60601-1-10 does not apply.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.247-2021_English be delivered?Answer: Upon your order, we will start to translate YY 9706.247-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 7 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY 9706.247-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY 9706.247-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|