HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 0987.4-2016 English PDF

US$479.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0987.4-2016: Implants for surgery--Magnetic resonance compatibility--Part 4: Radio frequency induced heating on or near passive implants test method
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0987.4-2016English479 Add to Cart 4 days [Need to translate] Implants for surgery--Magnetic resonance compatibility--Part 4: Radio frequency induced heating on or near passive implants test method Valid YY/T 0987.4-2016

PDF similar to YY/T 0987.4-2016


Standard similar to YY/T 0987.4-2016

YY/T 0987.2   YY/T 0987.1   YY/T 0987.3   YY 0989.3   YY/T 0989.5   

Basic data

Standard ID YY/T 0987.4-2016 (YY/T0987.4-2016)
Description (Translated English) Implants for surgery--Magnetic resonance compatibility--Part 4: Radio frequency induced heating on or near passive implants test method
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 24,290
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 0987.4-2016: Implants for surgery--Magnetic resonance compatibility--Part 4: Radio frequency induced heating on or near passive implants test method


---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.
Implations for surgery - Magnetic resonance compatibility - Part 4. Radio frequency induced heating on or near passive implants test method ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical Implants Magnetic Resonance Compatibility Part 4. radio frequency test method Implantsforsurgery-Magneticresonancecompatibility-Part 4. Radio 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Overview of test methods 3 5 meaning and application 3 Equipment and equipment 3 7 Test sample 3 8 Step 4 9 calorimetric measurement of saline solution body (body mold) average SAR value 11 10 Report 12 Appendix A (informative) Principle of test method 13 References 19

Foreword

YY/T 0987 "Surgical Implants Magnetic Resonance Compatibility" is divided into the following sections. - Part 1. Safety markings; - Part 2. Magnetic flux force test method; Part 3. Image artifact evaluation method; - Part 4. Radiofrequency test method; - Part 5. Magneto - induced torque test method. This part is part 4 of YY/T 0987. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section uses the re-drafting method for reference to ASTM F2182-2011a "Magnetic Resonance Environment in Passive Implants and Surrounding Tissues Radio Frequency Heat test method "preparation. The technical differences between this section and ASTM CF2182-2011a are as follows. --- on the normative reference documents, this part has made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. ● Replacement with ASTM Y2503-08 with YY/T 0987.1; YY/T 0987.2 instead of ASTM F2052-06; YY/T 0987.3 instead of ASTM F2119-07; ● Replacement with ASTM Y2213-06 with YY/T 0987.5; Replace Y 601-2-33..2002 with YY 0319-2008; --- remove the content of polyacrylic acid partial sodium salt and hydroxyethyl cellulose brand; - Remove Chapter 11, Chapter 12 and Appendix X1.10 of ASTM F2182-11a. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This section is proposed by the State Food and Drug Administration. This section is under the jurisdiction of the National Standardization Technical Committee on Surgical Implants and Orthopedic Instruments (SAC/TC110). This part of the drafting unit. the State Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, minimally invasive medical equipment (Shanghai) Limited company. The main drafters of this part. Miao Hui, Li Jia, Ma Jinzhu, Li Junfei, Shi Haifeng. Surgical Implants Magnetic Resonance Compatibility Part 4. radio frequency test method

1 Scope

This part of YY/T 0987 specifies tests for radiofrequency (RF) heating on passive implants or surrounding tissue by magnetic resonance imaging (MRI) method. This part of the test method is to determine whether the presence of medical devices in the MR imaging process will lead to injury to the patient one of the test methods. Other safety issues that need to be addressed include magnetic flux and torque and the functional realization of various configurations of medical devices in the MR environment. At a given specific absorptivity (SAR), the temperature rise caused by radio frequency depends on the frequency of the radio frequency, which in turn depends on the Magnetic field strength. The test methods in this section focus on the 1.5T or 3T cylindrical MR system, the MR system for other static magnetic field strengths Or magnet design, this part of the test method can be modified to evaluate the RF caused by the temperature rise. This part of the test hypothesis is carried out when the implant is completely in the body. For other implant conditions (such as external fixation equipment, puncture needle, guide Tube or tethered equipment such as ablation probe), the need to modify the test method. This part of the test method is applicable to a whole body magnetic resonance device with a whole body radio frequency transmitting coil, which is defined in YY 0319-2008 2.2.103, the definition of the whole body radio frequency transmitter coil see 2.2.100. Assume that the RF coil is an orthogonal excitation coil. This part uses the international unit value as the standard, this part does not contain other units of measurement.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Medical electrical equipment - Part 2-33. Particular requirements for the safety of magnetic resonance devices for medical diagnostics (IEC 60601-2 - 33..2002, IDT) YY/T 0987.1 Surgical implants - Magnetic resonance compatibility - Part 1. Safety signs YY/T 0987.2 Magnetic resonance compatibility of surgical implants - Part 2. Magnetic susceptibility test method YY/T 0987.3 Magnetic resonance compatibility of surgical implants - Part 3. Image artifact evaluation method YY/T 0987.5 Surgical implants - Magnetic resonance compatibility - Part 5. Magnetic torques test method NEMAMS8-2008 magnetic resonance imaging system specific absorption rate characteristics (Characterizationofthespecificabsorp- tionrate

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Salt gelatin geledsaline Sodium chloride and polyacrylic acid or sodium chloride and hydroxyethyl cellulose were dissolved in water in this part of the test medium. 3.2 Implant Medical means an object, device, or instrument that is intended to remain in the body for the purpose of diagnosis, repair, or other treatment.

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0987.4-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0987.4-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0987.4-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0987.4-2016_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 [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.