|
US$1369.00 · In stock
Delivery: <= 8 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1763-2021: Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1763-2021 | English | 1369 |
Add to Cart
|
8 days [Need to translate]
|
Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
| Valid |
YY/T 1763-2021
|
PDF similar to YY/T 1763-2021
Basic data | Standard ID | YY/T 1763-2021 (YY/T1763-2021) | | Description (Translated English) | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C43 | | Word Count Estimation | 74,778 | | Issuing agency(ies) | State Drug Administration | YY/T 1763-2021: Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
---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 - Medical light ion beam equipment - Performance characteristics
ICS 11.040.50
C43
People's Republic of China Pharmaceutical Industry Standards
Medical electrical equipment Medical light ion beam equipment
Performance characteristics
(IEC 62667.2017, MOD)
Released on 2021-03-09
2022-10-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions 1
4 Environmental conditions 8
4.1 Overview 8
4.2 Transportation and storage 8
4.3 Facility stability 8
5 Information provided to users 8
5.1 Overview 8
5.2 Expected parameters 9
6 Beam distribution 9
6.1 Light ion type 9
6.2 Energy 9
6.3 Beam gating 9
6.4 Frame 9
6.5 Bracket for beam limiting tube 11
6.6 Light ion beam limiting tube 11
6.7 Adjustable beam limiting devices (BLDs) 11
6.8 Isocenter 12
6.9 Horizontal expansion device (LSD) 13
6.10 Time constraints 14
6.11 Maintenance 16
7 Dose monitoring system 16
7.1 Overview 16
7.2 Standard test conditions for testing the dose monitoring system 17
7.3 Repeatability of MU output 17
7.4 Linearity of MU output 18
7.5 Off-axis response for modulated scanning beam flux monitoring 19
7.6 The effect of angular position on MU output 19
7.7 Stability of MU output 20
8 Depth dose characteristics 21
8.1 Non-range modulation field depth dose distribution 21
8.2 Range modulation technology 22
8.3 Range modulation depth dose distribution 23
8.4 Light ion range stability 23
9 Lateral distribution of light ion radiation field 25
9.1 Transverse curve of light ion field using scatterer or uniform scanning system 25
9.2 Transverse curve of light ion field using modulated scanning system 28
10 Light ion field with energy and fluence modulation (EFM) 29
10.1 User Information 29
10.2 Beam characteristics and dose system performance for delivering small doses 29
11 Irradiation time for a specified volume 29
11.1 User Information 29
11.2 Test 30
12 Instructions for the radiation field 30
12.1 Limiting tube bracket extension indicator 30
12.2 Indication of the position of multiple BLD components 30
12.3 Indication of light ion reference axis 30
12.4 Light field indicator 32
13 Patient support device 32
13.1 Overview 32
13.2 Bed surface 32
13.3 Coordinate system 35
13.4 Range of motion of the patient support device 35
Appendix A (informative appendix) provides the format of performance values 37
Reference 67
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method to amend and adopt IEC 62677.2017 "Medical Electrical Equipment Performance Characteristics of Medical Light Ion Beam Equipment".
The technical differences between this standard and IEC 62677.2017 and the reasons are as follows.
--- Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1.2005 AMD1.2012 with GB 9706.1 modified to adopt international standards;
● Replace IEC 60580.2000 with GB/T.20012 which is equivalent to adopting international standards;
● Since there are no specific clauses cited in the main body of this standard, IEC 60601-2-1.2009, IEC 60601-2-1.2009/
AMD1.2014.
--- Added terms and definitions "patient support device" (see 3.49).
The Chinese documents that have a consistent correspondence relationship with the normatively cited international documents in this standard are as follows.
---GB/T 18987-2015 radiotherapy equipment coordinates, movement and scale (IEC 61217.2008, IDT)
This standard has made the following editorial changes.
--- In order to supplement the explanation that the bed surface includes both the bed surface and the seat surface, to avoid causing ambiguity on the bed surface, 3.40 adds Note 2;
---Position accuracy and position repeatability should be in mm, 6.7.1e) 8), 9) editing errors, modify "cm" to "mm",
Consistent with Appendix A;
---Revised the editing error of 6.6 in Appendix A of IEC 62677.2017, and changed "30mm" to "300mm";
--- Deleted the "Terms and Definition Index" in IEC 62677.2017.
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 standard was proposed by the State Drug Administration.
This standard is organized by the National Medical Electrical Appliance Standardization Technical Committee, Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment Sub-Technical Committee (SAC/
TC10/SC3) Centralized.
Drafting organizations of this standard. Beijing Institute of Medical Device Inspection, Institute of Modern Physics, Chinese Academy of Sciences, Shanghai Aipuqiang Particle Equipment Co., Ltd.
the company.
The main drafters of this standard. Wang Peichen, Jiao Chunying, Fu Guotao, Feng Jian, Xie Binjun, Li Qiang, Liu Xinguo, Dai Zhongying, Shen Liren, Du Hanwen,
Dong Pengcheng.
Introduction
This standard specifies the performance characteristics and publication methods of radiation therapy light ion beam equipment. In addition to the performance characteristics required to be announced
In addition to the indicators, the corresponding test conditions and test methods are also included for the type test of light ion beam equipment. Through the performance characteristics in accordance with this standard
The sexual publication method enables direct comparison between the performance data of equipment of different manufacturers.
The test methods specified in this standard are recommended and can be replaced by other equivalent and appropriate methods. However, it should be fully realized that this standard
The performance characteristics of light ion beam equipment specified by the standards are closely related to its test methods and test conditions. The tests specified in this standard cannot ensure
Any light ion beam equipment meets its claimed performance during its working life. Due to the differences in equipment produced by different manufacturers, the system
Manufacturers can add more detailed information and special tests for each performance characteristic in their accompanying documents. This standard stipulates
The performance, test methods, and performance announcement methods are as basic and universal as possible.
Medical electrical equipment Medical light ion beam equipment
Performance characteristics
1 Scope
This standard specifies the performance characteristics and test procedures of medical light ion beam equipment.
This standard applies to light ion beam equipment with a single nuclear energy range of 10MeV~500MeV for the purpose of radiotherapy.
This standard does not apply to ion beam equipment other than light ion.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (GB 9706.1-2020,
IEC 60601-1.2012, MOD)
GB/T.20012 Medical electrical equipment dose area product meter (GB/T.20012-2005, IEC 60580.2003, IDT)
IEC 60601-2-64.2014 Medical Electrical Equipment Part 2-64.Basic Safety and Basic Performance of Light Ion Beam Medical Electrical Equipment
Special requirements (Medicalelectricalequipment-Part 2-64.Particularrequirementsforthebasicsafetyandes-
sentialperformanceoflightionbeammedicalelectricalequipment)
IEC TR60788.2004 Medical electrical equipment term definition compilation (Medicalelectricalequipment-Glossaryof
definedterms)
IEC 61217.2011 Radiotherapy equipment-coordinates, movement and scale (Radiotherapy equipment-Coordinates,
movementsandscales)
3 Terms and definitions
GB 9706.1, GB/T.20012, IEC 60601-2-64.2014, IEC TR60788.2004 and the following terms and definitions
Applies to this document.
3.1
Acceptance test
After new equipment is installed, or after a major modification of existing equipment, tests are carried out at the user’s site in order to verify compliance with the contract.
Note 1.During or after the acceptance test, immediately collect reference data as the standard for future routine tests.
Note 2.Rewrite IEC TR60788.2004, rm-70-01, modify-add "on user site".
3.2
Accompanyingdocmentation
Materials that accompany medical devices and contain user information, or medical device installation, use, or maintenance, especially information about safe use.
Note 1.The accompanying documents may be operating instructions, technical instructions, installation manuals, quick reference guides, etc.
Note 2.The accompanying documents may include auditory, visual or tactile materials, as well as multimedia-type materials.
Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1763-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 1763-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 5 ~ 8 working days. The lengthier the document the longer the lead time. Question 2: Can I share the purchased PDF of YY/T 1763-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1763-2021_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.
|