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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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