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GB/T 15214-2008 English PDF

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GB/T 15214-2008: Requirements and methods of reliability test for ultrasonic diagnostic equipment
Status: Valid

GB/T 15214: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB/T 15214-2008529 Add to Cart 4 days Requirements and methods of reliability test for ultrasonic diagnostic equipment Valid
GB/T 15214-1994679 Add to Cart 5 days Requirements and methods of reliability test for medical B mode ultrasonic diagnostic equipment Obsolete

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Basic data

Standard ID: GB/T 15214-2008 (GB/T15214-2008)
Description (Translated English): Requirements and methods of reliability test for ultrasonic diagnostic equipment
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C41
Classification of International Standard: 11.040.50
Word Count Estimation: 23,255
Date of Issue: 2008-11-03
Date of Implementation: 2009-10-01
Older Standard (superseded by this standard): GB/T 15214-1994
Quoted Standard: GB/T 3187; GB/T 3358.2; GB/T 5080.1; GB/T 5080.4; GB/T 5080.7; GJB 899-1990
Regulation (derived from): National Standard Approval Announcement 2008 No.18 (Total No.131)
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the basic requirements and test methods for ultrasound diagnostic equipment reliability test. And provides statistical reliability test pilot program and parameter estimation method. This standard applies to the failure to obey the law of exponential distribution reliability test ultrasound diagnostic equipment.

GB/T 15214-2008: Requirements and methods of reliability test for ultrasonic diagnostic equipment

---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.
Requirements and methods of reliability test for ultrasonic diagnostic equipment ICS 11.040.50 C41 National Standards of People's Republic of China Replacing GB/T 15214-1994 Ultrasound diagnostic equipment reliability testing Requirements and Methods Posted 2008-11-03 2009-10-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Foreword

This standard replaces GB/T 15214-1994 "B-type ultrasonic medical diagnostic equipment reliability test requirements and methods." Compared with the standard GB/T 15214-1994 The main changes are as follows. --- Since this standard applies to all ultrasound diagnostic equipment, it removed the standard name of "medical B mode"; --- Added some descriptive text; --- An increase of 2 Normative references (GJB899 and GB/T 3358); --- According to GB/T 3187 and GB/T 3358, regulate some terminology. the judgment of risk, consumer's risk producers and risk, And increases the English term, adds a terminology. the reliability of laboratory tests; --- Supplemented α = β = 30% of the test program; --- Amendments and supplements the "Select 4.3 Test Project"; --- Complement the relevant forms. censoring programs 5.9 and 4.9 truncated sequential test program; --- Supplemented confidence level of confidence when C = 40% of the limit factor; --- Fixed some numbers related to errors in the table; --- Effective bit Unified related table after the decimal point is four. This standard Annex A, Annex B, Annex C and Annex D is informative appendix. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee on Medical Electrical (SAC/TC10) medical ultrasound equipment standardization Technical Committee (SAC/TC10/SC2) centralized. This standard was drafted by the national medical ultrasound equipment Wuhan Quality Supervision and Inspection Center. The main drafters of this standard. Jiang Shilin. This standard replaces the previous standard release version. --- GB/T 15214-1994. Ultrasound diagnostic equipment reliability testing Requirements and Methods

1 Scope

This standard specifies the basic requirements and test methods for testing the reliability of ultrasound diagnostic equipment, and provides a statistical test of the reliability test Programs and methods of parameter estimation. This standard applies to the failure to obey the law of Exponential Distribution Reliability Test ultrasound diagnostic equipment.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 3187 reliability, maintainability terms The second part of the statistical quality GB/T 3358.2 statistical terms control term GB/T 5080.1 Equipment reliability testing - General requirements (GB/T 5080.1-1986, idt IEC 60605-1. 1978) GB/T 5080.4 Equipment reliability testing reliability test of the measurement point estimates and confidence intervals method (exponential distribution) GB/T 5080.7 Equipment reliability testing efficiency constant failure rate assumption under the MTBF of test plans (GB/T 5850.7-1986, idt IEC 60605-7. 1978) GJB899-1990 Reliability Qualification and Acceptance Test

3 Terms and Definitions

GB/T 3187 and GB/T 3358.2 and established the following terms and definitions apply to this standard. 3.1 No mean time between failures. 3.1.1 M1 is the true value unacceptable MTBF MTBF value, the device is close to m1, the standard recommended this test program will be high probability Rejected. 3.1.2 M1 0 is acceptable MTBF MTBF value of the true value, the device is close to m1 0.00, this standard recommends testing program will be high probability receive. 3.1.3 M1 p is in accordance with design, process equipment and operating environment is expected MTBF value method to determine with reliability. 3.1.4 Total accumulated equipment failures related to test time divided by the total number of related. Calculate the cumulative test time associated See GB/T 5080.4.
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