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YY/T 1841-2022 English PDF

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US$559.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1841-2022: Cardiac electrophysiology mapping system
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1841-2022	559	Add to Cart	5 days	Cardiac electrophysiology mapping system	Valid

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Basic data

Standard ID: YY/T 1841-2022 (YY/T1841-2022)
Description (Translated English): Cardiac electrophysiology mapping system
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C39
Word Count Estimation: 27,269
Issuing agency(ies): State Drug Administration

YY/T 1841-2022: Cardiac electrophysiology mapping 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.
Cardiac electrophysiology mapping system ICS 11.040.50 CCSC39 People's Republic of China Pharmaceutical Industry Standard Cardiac Electrophysiological Mapping System Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 4.1 Working conditions 2 4.1.1 Test conditions 2 4.1.2 Test device 2 4.1.3 Test circuit 2 4.2 ECG 2 4.3 Positioning performance 6 4.3.1 Positioning range 6 4.3.2 Positioning accuracy 6 4.3.3 Positioning stability 6 4.3.4 Positioning Repeatability Accuracy 6 4.3.5 Positioning angle accuracy 6 4.4 Pressure performance 6 4.4.1 Pressure accuracy 6 4.4.2 Pressure range 6 4.5 System software functions 6 4.6 Environmental test requirements 6 5 Test method 7 5.1 Working conditions7 5.1.1 Test conditions 7 5.1.2 Test device 7 5.1.3 Test circuit 8 5.2 ECG 8 5.2.1 Surface ECG 8 5.2.2 Intracardiogram 14 5.3 Positioning performance 18 5.3.1 Positioning range 18 5.3.2 Positioning accuracy 18 5.3.3 Positioning stability 18 5.3.4 Positioning Repeatability Accuracy 19 5.3.5 Positioning angle accuracy 19 5.4 Pressure performance 19 5.5 System software functions 19 5.6 Environmental test requirements 19 Appendix A (Informative) Positioning Performance Test Method 20

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is approved by the National Medical Electrical Equipment Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) focal point. This document was drafted by. Shanghai MicroPort Electrophysiology Technology Co., Ltd., Shanghai Medical Device Testing Institute, Philips (China) Investment Co., Ltd. The main drafters of this document. Song Yuwen, Hu Sheng, Hong Wei, Yin Hao, Lu Lingfeng. Cardiac Electrophysiological Mapping System

1 Scope

This document specifies the requirements and test methods for the cardiac electrophysiological mapping system (hereinafter referred to as the system). This document applies to cardiac electrophysiological mapping systems.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB 9706.1-2020 Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance GB 9706.225-2021 Medical Electrical Equipment Part 2-25.Special Requirements for Basic Safety and Basic Performance of Electrocardiographs GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 A system that uses the information obtained by magnetic field, electric field or magnetoelectric hybrid positioning to build a three-dimensional heart model, and converts the collected ECG The number is integrated on the model of the anatomical site. 3.2 locationrange The cardiac electrophysiological mapping system satisfies the space of positioning accuracy. 3.3 location accuracy In the three-dimensional positioning range, the difference between the actual position of the catheter and the displayed position of the system. 3.4 location stability The difference between the measured position of the catheter and the actual position is the change value generated by the prolongation of the working time of the cardiac electrophysiological mapping system. 3.5 The difference between the catheter moving to another position within the positioning range and returning to the expected position after a period of time. 3.6 orientationaccuracy The system displays the difference between the orientation of the catheter and the actual orientation within the positioning accuracy. 3.7 pressure range contactforcerange The pressure range that the catheter can measure. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1841-2022_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1841-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1841-2022_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1841-2022_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+ countries

Question 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 Sales@ChineseStandard.net. 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.