YY 0319: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0319-2008 | English | RFQ |
ASK
|
8 days [Need to translate]
|
Medical Electrical Equipment. Part 2-33: Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis
| Obsolete |
YY 0319-2008
|
| YY 0319-2000 | English | RFQ |
ASK
|
6 days [Need to translate]
|
Medical electrical equipment. Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
| Obsolete |
YY 0319-2000
|
PDF similar to YY 0319-2008
Basic data | Standard ID | YY 0319-2008 (YY0319-2008) | | Description (Translated English) | Medical Electrical Equipment. Part 2-33: Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 71,758 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-12-01 | | Older Standard (superseded by this standard) | YY 0319-2000 | | Quoted Standard | GB 9706.1-2007; GB 9706.15-1999; IEC 60601-1-4-1996 | | Adopted Standard | IEC 60601-2-33-2002, IDT | | Regulation (derived from) | SFDA [2008] No. 192 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to the definition of magnetic resonance equipment and 2. 2. 101 2. 2. 102 defined by the MRI system. This standard does not cover the intended use of magnetic resonance equipment for applications outside. This standard specifies the safety requirements for magnetic resonance equipment, designed to provide protection for patients. This standard provides the operator with magnetic resonance equipment related to staff and public information requirements. The specific standard that meets both of these requirements. | YY 0319-2008: Medical Electrical Equipment. Part 2-33: Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis
---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 2-33. Particular Requirements for the Safety of Magnetic Reconance Equipment for Medical Diagnosis
ICS 11.040.55
C43
People's Republic of China pharmaceutical industry standards
YY 0319-2008/IEC 60601-2-33.2002
Replacing YY 0319-2000
Medical electrical equipment -
Part 2-33. magnetic resonance equipment for medical diagnosis
Requirements for safety
(IEC 60601-2-33.2002, IDT)
Posted 2008-04-25
2009-12-01 implementation
State Food and Drug Administration issued
Table of Contents
Introduction Ⅲ
The first chapter Overview 1
1 Scope and purpose 1
2 Terms and definitions 2
3 General requirements 6
6 Identification, marking and documentation 6
The second environmental conditions 12
Third of the risk of electric shock protection 12
Title IV of the mechanical hazards Protection 12
26 12 Vibration and Noise
The fifth chapter unwanted or excessive radiation hazard protection 13
36 13 Electromagnetic Compatibility
Title VI of flammable anesthetic mixture ignition risk protection 13
Title VII of the ultra-moderate risk of other aspects of security protection 14
45 pressure vessels and pressure parts 14
Interrupt the power supply 49 14
14 accuracy and prevent the risk of the output data of the eighth chapter of the work
1451 to prevent the risk of output
Chapter 9. abnormal operation and fault conditions; environmental testing 28
52 abnormal operation and fault status 28
Tenth Canto structural requirements 28
59 and the wiring structure 28
Annex L (normative) References --- publications mentioned in this standard 29
Annex AA (informative) Warning symbols and prohibition symbols example 30
Appendix BB (informative) specific terms of guidance and Rationale 31
References 57
The term index 65
101 gradient waveforms and effective stimulus duration 5
Figure 102 for measuring the gradient noise output waveform 13
103 heart and peripheral nerve stimulation limit 17
Figure 104 at high temperature and humidity reduces the body SAR limit of 19
105 SAR pulse energy measurement hardware devices, using an orthogonal RF transmit coil 23
106 SAR pulse energy measurement hardware devices, using a linear RF transmit coil 24
Figure BB. 1 static magnetic field. the potential flow and arrest 40
Figure BB. 2 experimental data to human body magnetic resonance apparatus volunteers PNS threshold 48
Figure BB. 3 double logarithmic plot of experimental peripheral nerve stimulation threshold 48
YY 0319-2008/IEC 60601-2-33.2002
Figure BB. Eight pairs of patients exposed to quality SAR limit 55
Table 101 list of symbols 5
Table base value of 102 various types of intensity gradient system 16
104 Table 18 Temperature Limits
Table 105 SAR limit 18
Table BB. 1 static field professional standards 39
YY 0319-2008/IEC 60601-2-33.2002
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.
This standard was proposed by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard by the National Standardization Technical Committee on Medical Electrical Medical Electronic Instrument Standardization Technical Committee.
This standard was drafted. the Shanghai Medical Device Testing, Siemens Mindit (Shenzhen) Co., Ltd. MR.
The main drafters of this standard. Yu and Ni Cheng, Heai Qin, smart weapons.
This standard replaces the standard for the previous editions.
--- YY 0319-2000.
YY 0319-2008/IEC 60601-2-33.2002
Medical electrical equipment -
Part 2-33. magnetic resonance equipment for medical diagnosis
Requirements for safety
The first chapter outlines
Except for the following chapter and the General Standard Terms apply this Title.
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
YY 0319-2008/IEC 60601-2-33.2002
|