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YY 0637-2013 English 260 Add to Cart 0--15 minutes. Auto immediate delivery. Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems Valid YY 0637-2013
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Detail Information of YY 0637-2013; YY0637-2013
Description (Translated English): Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
Word Count Estimation: 29,264
Older Standard (superseded by this standard): YY 0637-2008
Quoted Standard: GB 9706.17-2009; IEC 60601-1-2005; IEC 60601-1-2; IEC 60601-2-1-2009; IEC/TR 60788-2004; IEC 60950-1; IEC 61000-4-1; IEC 61000-4-2; IEC 61000-4-3; IEC 61000-4-4; IEC 61217; IEC 62304; IEC 62366-2007; ICRU REPORT 42-1987
Adopted Standard: IEC 62083-2009; IDT
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Summary: This standard applies to: radiation treatment planning system (hereinafter referred to as the RTPS) design, manufacture, installation and use, etc, applied in medical practice radiation therapy treatment planning, input input data either by the operator,
YY 0637-2013/IEC 62083:2009
Replacing YY 0637-2008
Safety requirements for radiation treatment planning system
Medicalelectricalequipment-Requirementsforthesafetyofradiotherapy
treatmentplanningsystems
(IEC 62083:2009, IDT)
3 Terms, definitions and abbreviations 2
3.2 Acronyms 3
4 Summary 3
4.1 Development 3
4.2 Installation of Test 3
5 random file 3
6 General requirements for the safe operation of 5
6.1 distance and linear, angular dimensions 5
6.2 the amount of radiation 5
6.3 Date and time format 5
6.4 to prevent the unauthorized use 5
6.5 Data Range 6
6.6 Unauthorized modification of protection 6
6.7 6 accuracy of data transmission
6.8 coordinate system and scale 6
Save and archive data 7 6.9
7 Radiation therapy equipment configuration data and brachytherapy source data configuration 7
7.1 Device Data 7
7.2 brachytherapy source data 7
7.3 dosimetric parameters 8
7.4 device data, acceptance brachytherapy source data 8
7.5 device data, delete brachytherapy source data 8
8 virtual patients to establish 8
8.1 Data Acquisition 8
8.2 coordinate system and the scale 9
8.3 the outline of the region of interest 9
8.4 Acceptance anatomical data of 10 patients
Remove patient anatomical data 10 8.5
9 treatment planning 10
9.1 General requirements 10
9.2 prepare a treatment plan 10
11 9.3 Identification of the treatment plan
Delete treatment plan 11 9.4
11 9.5 Electronic Signatures
10 absorbed dose distribution calculation 11
10.1 algorithm used 11
Accuracy 10.2 Algorithm 11
11 Treatment Project Report 12
11.1 Incomplete treatment plan report 12
Treatment planning report 11.2 12
11.3 treatment plan information transmission 13
12 13 General hardware diagnostic requirements
Data and code 13 13
14 13 Software Design of human error
15 software version 14 changes
16 Using human error 14
Appendix A (normative) hardware security 15
Input and output Annex B (informative) data 17
This standard replaces YY 0637-2008 "Safety requirements for medical electrical equipment Radiation Treatment Planning System", and YY 0637-2008
Compared to the main technical changes are as follows:
--- Increased 3.2 Acronyms;
--- Delete the original standard in Chapter 3;
--- Original standard-based decomposed 8.1 standard 7.1 and 7.2;
--- Delete the original standard Chapter 14;
This standard is identical with IEC 62083:2009 "Safety requirements for electrical equipment for medical radiation treatment planning system."
Correspondence between the consistency of the standards of international documents and normative references of the following documents:
For ease of use, this standard made the following editorial changes:
--- The "international standard" be replaced by "this standard";
"." --- With a decimal point instead of a comma as the decimal point, "";
--- Delete foreword international standards;
This standard by the National Standardization Technical Committee appliances medical radiotherapy, nuclear medicine science equipment at the Technical Committee and the radiation dose
(SAC/TC10/SC3) centralized.
Drafting of this standard: Beijing Medical Device Testing, Shandong Xinhua Medical Instrument Co., Ltd., Shanghai Shi Peng Lab
Science and Technology Development Company Limited.
The main drafters of this standard: SONG Lian Yes, Wangpei Chen, Yin Xiaohui, Caoguo Gang.
This standard was first published in 2008.
Radiation treatment planning system (RTPS) usually is a programmable medical electrical systems used to simulate radiation therapy for the purpose of acting
Application of radiation patients. Typically (but not necessarily), the use of a particular algorithm or more algorithms to provide human tissue absorbed dose points
Cloth estimates. Estimated absorbed dose distribution as defined in this standard, can only be used by qualified personnel in the design of radiation therapy process.
The output RTPS as radiation treatment planning of important information for qualified personnel. Inaccurate input data, calculation
The limitations of law, improper use of treatment planning process errors, or output data, the use of these results may lead during treatment
Causing safety hazards to patients. This standard specifies the manufacturers in the design and construction RTPS process should comply with the requirements in order to prevent these
The standard does not specify the type of input data and calculation algorithms, because it depends on many factors such as: technical conditions, the responsibility of the organization habits,
Design type of treatment and the like. Nevertheless, this standard to establish a common safety requirements for the algorithm, and the establishment of minimum requirements for random files,
In order to make known to the operator to select the treatment planning process.
Since RTPS does not act directly on the patient, and therefore does not belong to RTPS Medical electrical equipment as defined in IEC 60601-1, so
Unlike using IEC 60601-1 independent writing format.
Basic security hardware, such as protection against electric shock, fire, and electromagnetic compatibility protection, are not included in this standard. Radiation treatment planning system is not based on
With the hardware environment and characteristics specified by the manufacturer alone to apply the appropriate standard. See Appendix A hardware security standards.
RTPS is used in medical software systems, IEC 62304 standard applies (see Chapter 14).
IEC 61217 gives an indication of the movement of medical electrical equipment, the scale of the scale, zero and guide the direction of the mobile value added.
IEC 61217 compliance verification test methods in terms of this standard is relevant to specify in detail.
IEC 62366 standard applies (see Chapter 16).
This standard applies to radiation treatment planning system (hereinafter referred to RTPS) the design, manufacture, installation and use of such areas;
--- Used in medical practice in radiation therapy treatment planning;
--- Data input either by an operator input, can also be obtained directly from other devices;
--- Output data can print Ventura reading can also be exported directly to other devices;
--- And expectations:
● under the authority of the appropriate license or qualified personnel, normally used by the operator with the required skills and training;
● Follow the instructions for use recommended maintenance methods, and;
● in the technical specification prescribed environmental and power supply conditions.
GB 9706.17-2009 Medical electrical equipment - Part 2: γ beam therapy equipment requirements for the safety (IEC 60601-2-11:
1997, IDT)
IEC 60601-1:2005 Medical electrical equipment: Part 1: Basic safety and essential performance General requirements (Medicalelectrical
equipment-Part 1: Generalrequirementsforbasicsafetyandessentialperformance)
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility requirements and tests
(Medicalelectricalequipment-Part 1-2: Generalrequirementsforbasicsafetyandessentialperform-
ance-Colateralstandard: Electromagneticcompatibility-Requirementsandtests)
IEC 60601-2-1:2009 Medical electrical equipment - Part 2: energy 1MeV safety of electron accelerators designed to 50MeV
With requirements (Medicalelectricalequipment-Part 2-1: Particularrequirementsforthebasicsafetyandes-
sentialperformanceofelectronacceleratorsintherange1MeVto50MeV)
IEC /T R60788:2004 Medical imaging academic language (Medicalelectricalequipment-Glossaryofde......