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YY 0319-2008Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis (English PDF)

医用电气设备 第2部分: 医疗诊断用磁共振设备安全专用要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

April 25, 2008

Implementation date

December 1, 2009

Scope

YY 0319-2008 is the English-translated version of 医用电气设备 第2部分: 医疗诊断用磁共振设备安全专用要求.

YY 0319-2008 is the Chinese pharmaceutical industry standard setting the particular safety requirements for magnetic resonance equipment used in medical diagnosis, identical to IEC 60601-2-33:2002 and its 2005 amendment.

It is read together with GB 9706.1, and adds rules on protecting patients from gradient output, cardiac and peripheral nerve stimulation, specific absorption rate (SAR) and temperature limits, static magnetic fields, vibration, acoustic noise and electromagnetic compatibility.

It also defines the information that must be given to operators, staff and the public, with example warning and prohibition symbols. Uses of MR equipment outside its intended purpose are not covered.

It replaces YY 0319-2000. Issued on 25 April 2008, it has applied since 1 December 2009.

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Document preview — YY 0319-2008

National Standard of the People's Republic of China

ICS
11.040.55
Classification
C 43
Replacing
YY 0319-2000

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Introduction The first chapter Overview
  • 1 Scope and purpose
  • 2 Terms and definitions
  • 3 General requirements
  • 6 Identification, marking and documentation
  • 26 12 Vibration and Noise The fifth chapter unwanted or excessive radiation hazard protection
  • 36 13 Electromagnetic Compatibility Title VI of flammable anesthetic mixture ignition risk protection
  • 45 pressure vessels and pressure parts
  • 14 accuracy and prevent the risk of the output data of the eighth chapter of the work Chapter 9. abnormal operation and fault conditions; environmental testing
  • 52 abnormal operation and fault status
  • 59 and the wiring structure
  • Annex L (normative) References --- publications mentioned in this standard
  • Annex AA (informative) Warning symbols and prohibition symbols example
  • Appendix BB (informative) specific terms of guidance and Rationale
  • References
  • 101 gradient waveforms and effective stimulus duration
  • 103 heart and peripheral nerve stimulation limit
  • 105 SAR pulse energy measurement hardware devices, using an orthogonal RF transmit coil
  • 106 SAR pulse energy measurement hardware devices, using a linear RF transmit coil
  • 104 Table 18 Temperature Limits

Foreword

This standard is identical with IEC 60601-2-33:2002 "Medical electrical equipment - Part 2. Safety of magnetic resonance equipment for medical diagnosis professionals With the requirements "and in the No. 1 amendments (2005). This standard international standards made the following editorial changes.

--- Remove IEC 60601-2-33:2002 standard covers, foreword and introduction;

--- Use the decimal symbol replaces the decimal symbol ",". ",";

--- Due to Chinese layout, page numbers, change the font and font size, etc., shall not affect the degree of consistency.

This standard replaces YY 0319-2000 "Medical electrical equipment - Part 2. Safety of magnetic resonance equipment for medical diagnosis-specific requirements." The main difference between this standard and YY 0319-2000 follows.

--- Add to or modify some of the terms and definitions;

--- Add to or modify the requirements for random files;

--- Added a Chapter 36 "Electromagnetic Compatibility";

Requirements and test methods --- supplement or modify the eighth chapter, "accuracy and dangerous work output data to prevent" the improvement of the "gradient Output limits "," SAR limit "and other specific safety requirements for magnetic resonance equipment.

This standard is a normative appendix Appendix L, appendix AA, BB appendix is informative appendix.

1 Scope and purpose

Except as follows, common standards in this chapter apply.

1.1 Scope

Addition.

This standard applies to specific defined by the magnetic resonance apparatus 2.2.101 and 2.2.102 defined by the magnetic resonance system.

This standard does not cover the use of magnetic resonance equipment other than the intended purpose.

1.2 Purpose

replace.

This standard specifies the special safety requirements for magnetic resonance equipment, designed to provide protection for patients.

This standard specifies specific to the operator, staff and magnetic resonance apparatus and associated public requests for information.

The standard also provides specific proof method to meet these requirements.

1.3 Specific Standard

Addition.

The specific standard amendments and additions to the following publications, hereinafter referred to as "common standards", comprising.

GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT)

GB 9706.15-1999 Medical electrical equipment Part 1. General requirements for safety 1. Collateral standard. medical electrical systems security Requirements (idt IEC 60601-1-1:1995)

IEC 60601-1-4:1996 Medical electrical equipment - Part 1. General requirements for safety 4. Collateral standard. a programmable electrical medical Gas system For brevity, this standard will be dedicated in GB 9706.1 known as the "General Standard" or "General requirements", and the GB 9706.15

IEC 60601-1-4 called "collateral standard." The term "this standard" coverage of the specific standard, it is tied with common standards and any use of common standards.

The specific standard of articles, chapters and numbered in accordance with the provisions of the General Standard corresponding to the number. Use the following words when you change the text of the General Standard Department statement. "Replace" refers to the content of the General Standard chapters or articles dedicated entirely replaced by the contents of this standard; "Supplement" refers to the contents of this specific standards to common standards requirements; "Modify" refers to the content of the General Standard chapter or modify the terms of the cost of specific standard expressed it.

Added to the general standard terms and Figures are numbered starting from 101, with the addition of the Appendix AA, BB, etc. No, but the addition of the item with the aa), bb) and other numbers.

There are chapters explain the terms of the principle are marked with "*". These principles may be found in the informative annex BB. Appendix BB is not Part of this standard, which provides additional information only; it is not a topic tests.

Articles, chapters or provisions of the General Standard or specific mention of the specific standard is not the standard parallel those articles, chapters or terms without modification

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 65 pages — is available in the English PDF.

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Editions of YY 0319

EditionTitleRevisionStatus
YY 0319-2008Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosiscurrent editionCurrent
YY 0319-2000Medical Electrical Equipment - Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosisprevious editionSuperseded

This page sells the current edition, YY 0319-2008. Earlier editions are listed for reference only.

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