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YY 0721-2009: Medical electrical equipment-Safety of radiotherapy record and verify systems
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Medical electrical equipment-Safety of radiotherapy record and verify systems
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YY 0721-2009
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Basic data | Standard ID | YY 0721-2009 (YY0721-2009) | | Description (Translated English) | Medical electrical equipment-Safety of radiotherapy record and verify systems | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 13,172 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Quoted Standard | GB 4943; GB 9706.1; GB 9706.16; GB/T 17857; GB/T 18987; YY 0505; IEC 60601-1-4-1996; IEC 61000 | | Adopted Standard | IEC 62274-2005, IDT | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard applies to medical records in the field of radiation therapy and verification system (RVS) the design, manufacture and installation of certain aspects. This recording and verification system (RVS): a) providing, define the treatment unit or the display setting data, from the manual input of data or to import data from other devices, b) to control the equipment operation, c) throughout the treatment phase of the data record, d) expected to be used: a) in the qualified personnel or personnel have the appropriate license under the authority of the relevant technologies and by a trained operator normal use, 2) in accordance with the instruction manual for maintenance recommendations, 3) in the technical description Description of environmental conditions and supply conditions. This standard does not involve the implementation of dynamic beam therapy. | YY 0721-2009: Medical electrical equipment-Safety of radiotherapy record and verify systems---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-Safety of radiotherapy record and verify systems
ICS 11.040.60
C43
People's Republic of China pharmaceutical industry standards
YY 0721-2009/IEC 62274.2005
Medical electrical equipment -
Security radiotherapy record and verify systems
(IEC 62274.2005, IDT)
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
This standard is identical with IEC 62274.2005 "Medical electrical equipment - Safety of radiotherapy record and verify systems."
For ease of use, this standard made the following editorial changes.
--- Deleting IEC 62274.2005 Foreword;
--- For other international standards quoted in the standard, if it has converted to our standards, this section replaces the corresponding international standards by the national number
Standard.
Appendix A of this standard is a normative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard by the National Radiological medical treatment appliances Standardization Technical Committee, the Technical Committee of nuclear science equipment Medical and radiation dose
(SAC/TC10/SC3) centralized.
This standard was drafted. Beijing Medical Device Testing.
The main drafters of this standard. Hu Jia, Feng Jian, Goofy, Chen Jing, Xu Yan.
YY 0721-2009/IEC 62274.2005
Introduction
Radiation treatment records and verification system (RVS) is a programmable medical electrical systems (PEMS) or subsystem, to help preventing
Subsystem only medical electron accelerators, γ-rays or other radiation therapy treatment device device error parameters, and record all treatment order
segment. If the (machine) the current parameters with preset parameters do not match, RVS verified these parameters to prevent the machine running. In the recording and verification
Process inaccuracies and erroneous data will pose a security risk to the patient. In order to provide protection against such security risk,
This standard defines the manufacturers to follow when designing and building RVS requirements.
YY 0721-2009/IEC 62274.2005
Medical electrical equipment -
Security radiotherapy record and verify systems
1 Scope and purpose
1.1 Scope
This standard applies to the medical field radiotherapy record and verify systems (RVS) the design, manufacture and installation of certain aspects. This
Kinds of recording and verification system (RVS).
a) providing a definition of the treatment machine or setting data display; manually enter data or import data directly from other devices;
b) controls the equipment operation;
c) recording data throughout the treatment period;
d) intended for.
1) under the authority of the appropriate license or have qualified personnel staff, having relevant technical and trained operators are
Often used;
2) in accordance with the instructions of recommendations for maintenance;
3) used in the technical specifications under the environmental conditions and supply conditions described.
This standard does not address the treatment of the implementation of dynamic ray beam.
Note. The implementation of dynamic beam treatment may be described in future versions of the standard.
However, it is directed to certain specific aspects connected with or other radiation therapy equipment RVS and connected to a network system, and make
With the communication protocol.
1.2 Purpose
This standard applies to any RVS, RVS and provides characteristics, relevant documentation and software testing requirements. Hardware security
Requirements not included in this standard, because the hardware security requirements vary with different hardware itself (see 1.3.1 and Appendix A
Section on hardware requirements).
This standard does not apply to user-developed and only RTPS own use, but developers are encouraged to use this standard in the development and use.
If such RTPS was developed by those who can not directly control its use by other users to use, and a description of this system is suitable for use, then
Developers will be considered for the manufacturer and must comply with this standard.
1.3 Relationship with other standards
1.3.1 Hardware Security Standard
This standard does not include hardware security requirements, such as to prevent electrical shock, fire, and electromagnetic compatibility of hardware security. Safety requirements in accordance with the manufacturer
Hardware environment and characteristics RVS use a separate statement of compliance with applicable relevant standards (standards for hardware security, see Appendix A).
1.3.2 software safety standards
IEC 60601-1-4 (see 4.1) all chapter shall apply.
The risk of using IEC 60601-1-4, the manufacturer should take into account the errors that may occur when using the RVS in.
Note. IEC 60601-1-6 describes the use of the wrong risk management process.
1.3.3 GB/T 18987
GB/T 18987 "Radiotherapy equipment Coordinates, movements and scales," apply. GB/T 18987 for use in the present standard applicable
When the article explained.
1.3.4 Other criteria
Because RVS likely to contain relevant information and other medical patient data, and confidentiality and security of electronic patient information recording phase
YY 0721-2009/IEC 62274.2005
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