GB 9706.254-2020Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (English PDF)

Foreword

GB 9706 "Medical Electrical Equipment" is divided into the following parts:

---Part 1: General requirements for basic safety and basic performance;

---Part 1-3: General requirements for basic safety and basic performance Parallel standard: Radiation protection of diagnostic X-ray equipment;

---Part 2-1: Specific requirements for the basic safety and basic performance of electron accelerators with energy from 1MeV to 50MeV;

---Part 2-2: Special requirements for the basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories;

---Part 2-3: Special requirements for basic safety and basic performance of shortwave treatment equipment;

---Part 2-4: Special requirements for the basic safety and basic performance of cardiac defibrillators;

---Part 2-5: Special requirements for the basic safety and basic performance of ultrasonic physical therapy equipment;

---Part 2-6: Special requirements for the basic safety and basic performance of microwave therapy equipment;

---Part 2-8: Special requirements for the basic safety and basic performance of therapeutic X-ray equipment with an energy of 10kV to 1MV;

---Part 2-11: Special requirements for basic safety and basic performance of gamma beam therapy equipment;

---Part 2-12: Special requirements for basic safety and basic performance of intensive care ventilators;

---Part 2-13: Special requirements for basic safety and basic performance of anesthesia workstations;

---Part 2-16: Specific requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment;

---Part 2-17: Special requirements for basic safety and basic performance of automatic control brachytherapy after-installation equipment;

---Part 2-18: Specific requirements for basic safety and basic performance of endoscopic equipment;

---Part 2-19: Special requirements for basic safety and basic performance of infant incubators;

---Part 2-22: Special requirements for basic safety and basic performance of laser equipment for surgery, plastic surgery, treatment and diagnosis;

---Part 2-24: Specific requirements for basic safety and basic performance of infusion pumps and infusion controllers;

---Part 2-25: Special requirements for basic safety and basic performance of electrocardiograph;

---Part 2-26: Specific requirements for the basic safety and basic performance of EEG machines;

---Part 2-27: Special requirements for basic safety and basic performance of ECG monitoring equipment;

---Part 2-28: Special requirements for the basic safety and basic performance of medical diagnostic X-ray tube components;

---Part 2-29: Specific requirements for the basic safety and basic performance of radiotherapy simulators;

---Part 2-36: Specific requirements for the basic safety and basic performance of in vitro lithotripsy equipment;

---Part 2-37: Special requirements for the basic safety and basic performance of ultrasonic diagnostic and monitoring equipment;

---Part 2-39: Specific requirements for the basic safety and basic performance of peritoneal dialysis equipment;

---Part 2-43: Special requirements for the basic safety and basic performance of interventional X-ray equipment;

---Part 2-44: Special requirements for the basic safety and basic performance of X-ray computed tomography equipment;

---Part 2-45: The basic safety and basic performance of mammography equipment and mammography stereotaxic devices Claim;

--- Part 2-54: Specific requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment;

---Part 2-60: Special requirements for basic safety and basic performance of dental equipment;

---Part 2-63: Special requirements for the basic safety and basic performance of extraoral imaging dental X-ray machines;

---Part 2-65: Specific requirements for the basic safety and basic performance of intraoral imaging dental X-ray machines;

---Part 2-66: Special requirements for basic safety and basic performance of hearing equipment and hearing equipment system:

This part is part 2-54 of GB 9706:

This section was drafted in accordance with the rules given in GB/T 1.1-2009:

This part uses the redrafting law to amend and adopt IEC 60601-2-54:2018 ``Medical Electrical Equipment Part 2-54: X-ray Photography Special requirements for basic safety and basic performance of fluoroscopy equipment:

The technical differences between this part and IEC 60601-2-54:2018 and the reasons are as follows:

---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments:

The situation is collectively reflected in:201:2 "Normative Reference Documents", and the specific adjustments are as follows:

- Replace IEC 60601-1:2012 (see:201:2 and related clauses Text);

- Replace IEC 60601-1-3:2013 (see:201:2 and related Provisions);

- Replace IEC 60580:2000 (see:201:2) with GB/T 20012-2005 which is equivalent to adopting international standards;

- Replace IEC 60336 with YY/T 0063 which is equivalent to adopting international standards;

- Replace IEC 60806 with YY/T 0479 equivalent to adopting international standards;

- Replace IEC 60601-1-2 with YY0505 which is equivalent to adopting international standards (see:201:1:3 and related provisions);

- Replace IEC 60601-1-8:2003 (see:201:1:3) with YY0709-2009, which is equivalent to the international standard;

- Removed IEC 62220-1-1:2015 (not cited in the standard):

--- Delete the last sentence of the third paragraph in the International Standard:201:1:3 "Alotherpublishedcolateralstandardsinthe IEC 60601-1seriesapplyaspublished":

This section has made the following editorial changes:

---All terms are represented in bold;

--- Amend "Meet local regulations" in 203:6:3:101 to "Meet Chinese regulations";

---The term index of the international standard has been deleted:

Please note that certain contents of this document may involve patents: The issuing agency of this document is not responsible for identifying these patents:

This part is proposed and managed by the State Drug Administration:

Medical Electrical Equipment Part 2-54:

Basic safety and safety of X-ray photography and fluoroscopy equipment Special requirements for basic performance

201.1 Scope, purpose and related standards in addition to the following, Chapter 1 of the general standard 1) applies:

1) The general standard is GB 9706.1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance":

201.1.1 Scope

replace:

This section applies to the basic safety and basicity of ME equipment and ME systems that are expected to be used for projection and indirect fluoroscopy:

can: GB 9706.23 applies to ME equipment and ME systems used for interventional operations, and refers to the applicable requirements of this special standard:

This section does not apply to ME intended for bone or tissue absorption densitometer, computed tomography, mammography, dentistry or radiotherapy:

Equipment and ME system: This section does not apply to radiation therapy simulators:

If a certain chapter is only applicable to ME equipment, or only applicable to ME systems, the title and content of the chapter will be explained: If not in this case, the regulations apply to both ME equipment and ME systems:

201.1.2 Purpose

replace:

The purpose of this section is to establish specific requirements for basic safety and basic performance for ME equipment and ME systems for photography and perspective:

201.1.3 Parallel standards Supplement:

This special standard refers to Chapter 2 of the general standard and applicable parallel standards listed in:201:2 of this special standard:

YY0505 and GB 9706.103 are applicable after Chapter 202 and Chapter 203 are revised:

YY0709, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 are not applicable:

Note: The operator of X-ray equipment is accustomed to the auditory signals required by this section, rather than the concept in YY0709: Therefore YY0709 is not applicable:

201.1.4 Specific standards Supplement:

Special standards can modify, replace or delete requirements contained in general standards or parallel standards to apply to the ME equipment under consideration, or Increase other basic safety and basic performance requirements:

Specific standard requirements take precedence over general standards:

In this section, GB 9706.1 is called the general standard: Parallel standards are indicated by their standard numbers:

The numbering of the chapters and articles in this part corresponds to the general standard by adding the prefix "201" (for example,:201:1 in this special standard corresponds to the general standard Standard Chapter 1), or by adding the prefix "20×" to correspond to the applicable parallel standard, where × is the international standard corresponding to the parallel standard:

The last digit of the number (for example, 202:4 in this special standard corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-2, in this special standard 203:4 corresponds to the content of Chapter 4 in the parallel standard IEC 60601-1-3, etc:):