|
US$2109.00 · In stock
Delivery: <= 11 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 9706.233-2021: Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 9706.233-2021 | English | 2109 |
Add to Cart
|
11 days [Need to translate]
|
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
| Valid |
YY 9706.233-2021
|
PDF similar to YY 9706.233-2021
Basic data | Standard ID | YY 9706.233-2021 (YY9706.233-2021) | | Description (Translated English) | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C43 | | Word Count Estimation | 114,172 | | Issuing agency(ies) | State Drug Administration | YY 9706.233-2021: Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance 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 basic safety and essential performance of magnetic resonance equipment for medical diagnosis
ICS 11.040.55
C43
People's Republic of China Pharmaceutical Industry Standards
Replacing YY 0319-2008
Medical Electrical Equipment Part 2-33.Medical
Basic safety and safety of diagnostic magnetic resonance equipment
Special requirements for basic performance
(IEC 60601-2-33.2015, MOD)
Released on 2021-03-09 and implemented on 2023-05-01
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
201.1 Scope, purpose and related standards 1
201.2 Normative references 2
201.3 Terms and Definitions 2
201.4 General requirements 8
201.5 General requirements for testing of medical equipment 8
201.6 Classification of medical electrical equipment and systems 8
201.7 Identification, marking and documentation of medical electrical equipment 8
201.8 Protection against the risk of electric shock 18
201.9 Protection against mechanical hazards 18
201.10 Protection against unnecessary or excessive radiation risks 19
201.11 Protection against over-temperature and other safety hazards 19
201.12 Accuracy of control, prevention of instrument and hazardous output 19
201.13 Abnormal operation and fault status 35
201.14 Programmable Medical Electrical System (PEMS) 35
201.15 ME equipment structure 35
201.16 Medical electrical system 35
201.17 *Electromagnetic compatibility of medical electrical equipment and systems 36
202 *Electromagnetic Compatibility---Requirements and Tests 36
Appendix D (informative appendix) Symbols 38
Appendix AA (informative appendix) Guide to special terms and explanation of principles 42
Appendix BB (informative appendix) Test method for acoustic noise of magnetic resonance system 82
Appendix CC (informative appendix) Magnetic resonance system SAR test method 88
References 97
Figure.201.101 Gradient waveform and effective stimulus duration 3
Figure.201.102 Limits of cardiac and peripheral nerve stimulation 23
Figure.201.103 Reduction of whole body SAR limit at high temperature 26
Figure.201.104 The volume used to confirm the maximum value of the gradient output space 31
Figure.201.105 Used to determine the volume of B1 stray field 32
Table.201.101 List of symbols and abbreviations 8
Table.201.102 Base strength of various types of gradient systems 23
Table.201.103 Weight factor 24 for the sum of the maximum output Oi of each type of gradient unit
Table.201.104 Temperature limits 24
Table.201.105 SAR limits for volume transmitter coils 25
Table.201.106 SAR limits for local transmitting coils 26
Table.201.107 FPO limits applicable to cylindrical magnetic resonance systems 34
Foreword
All technical content in this section is mandatory.
The "Medical Electrical Equipment" series of standards is divided into two parts.
---Part 1.General and parallel requirements;
---Part 2.Special requirements.
This part is part 2-33.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0319-2008 "Medical Electrical Equipment Part 2-33.Special Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
Compared with YY 0319-2008, the main technical changes in this part are as follows.
---Added the requirements of the compatibility technical specification sheet [see.201.7.9.3.101b)];
---Added functional requirements in the user interface [see.201.7.9.2.101w)];
---Modified the SAR limit (mainly for temperature and local SAR, see.201.12.4.103, 51.103 of YY 0319-2008);
---Modified the static magnetic field protection limit (see.201.12.4.104, 51.104 of YY 0319-2008);
--- Increased the maximum radio frequency absorbed energy dose limit (see.201.12.4.103.2 for details);
---Added the options of "Fixed Parameter Options" (see.201.12.4.106 for details);
---Modified the noise measurement method (see Appendix BB, 26 of YY 0319-2008).
This part uses the redrafting law to amend and adopt IEC 60601-2-33.2015 "Medical Electrical Equipment Part 2-33.For Medical Diagnosis
Special Requirements for the Safety of Magnetic Resonance Equipment.
The technical differences between this part and IEC 60601-2-33.2015 and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter.201.2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1-2.2014 with YY 9706.102 which is modified to adopt international standards;
● Replace IEC 60601-1.2012 with GB 9706.1 which is modified to adopt international standards;
● Due to non-standard quotation of IEC 60601-1-6.2013, IEC 60601-1-6.2013 was deleted;
● Due to non-standard quotation of IEC 60601-1-8.2012, IEC 60601-1-8.2012 is deleted;
● Deleted NEMAMS4.2010;
● Deleted NEMAMS8.2008.
---In order to match GB 9706.1-2020, the content of the electromagnetic compatibility part of the standard, IEC 60601-1-2 quoted by the original text.
2014 was revised to quote the content of IEC 60601-1-2.2007.
This section also made the following editorial changes.
---Informative appendix BB is added, and the content refers to NEMAMS4.2010;
---Informative appendix CC is added, and the content refers to NEMAMS8.2008.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Electrical Apparatus Standardization Technical Committee Medical Electronic Instrument Subcommittee (SAC/TC10/SC5).
Drafting organizations of this section. Siemens (Shenzhen) Magnetic Resonance Co., Ltd., Shanghai Medical Device Testing Institute, Shanghai United Imaging Medical Technology Co., Ltd.
the company.
The main drafters of this section. Wang Jun, Hu Sheng, He Qiang, Weng Dehe, Yang Yu, Xing Xiaocong.
The previous releases of the standards replaced by this part are as follows.
---YY 0319-2002, YY 0319-2008.
Medical Electrical Equipment Part 2-33.Medical
Basic safety and safety of diagnostic magnetic resonance equipment
Special requirements for basic performance
201.1 Scope, purpose and related standards
In addition to the following, Chapter 1 of the general standard 1) applies.
1) The general standard is GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Basic Performance".
201.1.1 Scope
replace.
This part specifies the special requirements for the basic safety and basic performance of magnetic resonance equipment for medical diagnostics. This part is applicable to medical diagnostics.
Magnetic resonance equipment (hereinafter referred to as ME equipment).
This section does not cover applications other than the intended use of magnetic resonance equipment.
If a clause or sub-clause is specifically expected to apply only to ME equipment, or only to ME systems, the subject of the clause or sub-clause
The questions and content will be explained. Otherwise, this clause or sub-clause applies to both ME equipment and ME system.
This section does not cover special requirements for the use of magnetic resonance equipment or magnetic resonance systems in interventional procedures.
201.1.2 Purpose
replace.
The purpose of this part is to put forward special requirements for basic performance and basic safety of magnetic resonance equipment (defined in.201.218 and.201.320).
Designed to provide protection for patients and MRI staff.
201.1.3 Parallel standards
supplement.
This section refers to the applicable parallel standards listed in Chapter 2 of the General Standard and Chapter.201.2 of this Part.
The application modification of YY 9706.102 is in Chapter 202.GB 9706.103, YY/T 9706.110, YY/T 9706.111 and
YY/T 9706.112 is not applicable. All other published parallel standards in the series of general requirements for medical electrical safety are in accordance with the published standards.
Implement.
201.1.4 Specific standards
replace.
In the series of medical electrical safety standards, considering the application of special ME equipment, special standards can be modified, replaced or deleted.
The requirements contained in the standard and parallel standards, and other basic safety and basic performance requirements can be added.
The requirements of specific standards take precedence over the requirements of general standards.
For brevity, GB 9706.1 is referred to as the general standard in this section. The parallel standard quotes its document number.
The numbering of the chapters and articles in this part corresponds to the general standard number plus the prefix "201" (for example,.201.1 in this part corresponds to the general standard number).
Corresponding to the content in Chapter 1 of the Standard), or the applicable parallel standard number plus the prefix "20x", where x is the end of the parallel standard document number
One digit (for example, 202.4 in this part corresponds to the content of Chapter 4 in the collateral standard YY 9706.102, 203.4 in this part
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.233-2021_English be delivered?Answer: Upon your order, we will start to translate YY 9706.233-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 7 ~ 11 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY 9706.233-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY 9706.233-2021_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+ countriesQuestion 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.
|