YY 0721-2009Medical electrical equipment - Safety of radiotherapy record and verify systems (English PDF)
医用电气设备 放射治疗记录与验证系统的安全
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
June 16, 2009
Implementation date
December 1, 2010
Scope
YY 0721-2009 is the English-translated version of 医用电气设备 放射治疗记录与验证系统的安全.
YY 0721-2009 is the Chinese standard "Medical electrical equipment - Safety of radiotherapy record and verify systems". Its scope clause reads: 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.
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.
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). Its clauses include scope and purpose.
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Document preview — YY 0721-2009
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C43
Issued by: National Medical Products Administration
Contents
- Foreword
- Introduction
- 1 Scope and purpose
- 1.1 Scope
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
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