Foreword
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the parts of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the Subcommittee of Medical X-ray Equipment of the National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 1).
Particular specifications for CT injector
1 Scope
This standard specifies the terms and definitions, classification and composition, requirements and test methods of the CT (X-ray computed tomography) injector (hereinafter referred to as "injector").
This standard is applicable to injectors. This standard does not involve disposable syringes and other accessories for injectors.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety
GB 9706.15-2008 Medical electrical equipment - Part1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
YY 0076-1992 Coating classifications for metal product - Technical conditions
YY 0505-2012 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY/T 0708-2009 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 10149-1988 and the following apply.
3.1
CT contrast enhanced scan
CT scan after injection of contrast agent into blood vessels
3.2
CT injector
device for injecting contrast agent into human body according to a set flow rate and injection dose
3.3
injector head
interface part for injection push mechanism and mounting matching syringe
3.4
flow rate
dose of contrast agent injected per unit time
In mL/s
3.5
maximum injection pressure
maximum pressure that the injector may reach during injection
In MPa
3.6
pressure limit
maximum allowable pressure of the injector is set during injection
In MPa
3.7
injection delay
after receiving the start signal, the injector starts injection after a set delay time
3.8
scan delay
after starting injection, the injector sends out a trigger signal after a set delay time
3.9
inject time
time from starting injection to stopping injection
3.10
fill rate
dose of contrast agent suctioned by the injector per unit time
In mL/s
4 Composition and classification
4.1 Composition
The injector is at least composed of a driving and control system, a supporting fixed part and accessories.
4.2 Classification
The injector may be structurally divided into:
a) Single-syringe injector;
b) Double-syringe injector;
c) Syring-free injector.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Composition and classification
5 Requirements
6 Test methods
