气囊式体外反搏装置（英文版）
英文名称： The air-bag type sequential external counter-pulsation device
替代情况： 替代GB 10035-1994
中标分类： 医药、卫生、劳动保护>>医疗器械>>C45体外循环、人工脏器、假体装置
ICS分类： 医药卫生技术>>医疗设备>>11.040.60治疗设备
发布部门： 中华人民共和国国家质量监督检验检疫总局 中国国家标准化管理委员会
发布日期： 2006-03-13
实施日期： 2006-10-01
首发日期： 1988-12-10
归口单位： 全国医用体外循环设备标准化技术委员会
主管部门： 国家食品药品监督管理局
起草单位： 广州市华南医疗器械有限公司
起草人： 梁小明、张雪漫、梁志坚、李晶
页数： 平装16开/页数：23/字数：38千字
出版社： 中国标准出版社
出版日期： 2006-10-01
本标准规定了气囊式体外反搏装置的术语和定义、分类和标记、要求、试验方法、检验规则、标志、包装、运输、贮存；
适用于各种类型气囊式体外反搏装置。
该反搏装置供医疗单位用于临床治疗心、脑、肾等器官的缺血性疾病，并有康复、保健功能。
Content
1. Scope
2. Normative Reference
3. Terms and Definitions
4. Classification and Marking
5. Requirement
6. Test Methods
7. Test Rules
8. Marking, Packaging, Transport and Storage
Annex A (Normative) Safety Requirement, Test Method and Inspection Rules
1. Scope
This standard specifies terms and definitions, classification and symbol, requirement, test methods, test rules, markings, packaging, transport and storage of air-bag type sequential external counter-pulsation device.
This standard is applicable to all kinds of air-bag type sequential external counter-pulsation device (hereinafter referred to as counter-pulsation device). Counter-pulsation device can be used by medical treatment organizations to treat clinic ischemia diseases of organs, such as heart, brain and kidney, and it has functions of recovery and health protection.
2. Normative Reference
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to, or revisions of (excluding corrigendum), any of these publications do not apply. However, parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the normative document referred to applies.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods (GB/T 191-2000, eqv ISO 780:1997)
GB 5013.1-1997 Rubber Insulated Cables of Rated Voltages up to and including 450/750V Part 1: General Requirements (idt IEC 60601-1:1998)
GB 9706.1-1995 Medical Electrical Equipment -- Part 1: General Requirements for Safety
GB 9969.1 General Principles for Preparation of Instructions for Use of Industrial Products
GB/T 14710-1993 The Environmental Requirements and Test Methods for Medical Electrical Equipment
3. Terms and Definitions
The following terms and definitions are applicable hereto.
3.1
Air-bag type sequential external counter-pulsation device
An assistant circulation device that is used outside human body, synchronizes with cardiac electricity and can obviously improve diastolic pressure of human body and cancel pressure before systole to reduce systolic pressure through an air-bag providing appropriate air pressure to human body during diastole.
3.2
Sequential type
Applying degressive air pressures in sequence from far end to near end of the heart.
3.3
Positive pressure type
Making air-bag to discharge air naturally through opening the air-discharging electromagnetic valve before systole, based on the difference between air pressure in the air-bag and atmospheric pressure.
3.4
Negative pressure type
Using negative pressure to discharge air from the air-bag before systole.
3.5
Augmented type
Besides limb air-bags, buttocks air-bag is added to improve the effect of counter pulsation.
3.6
Operating pressure
Peak pressure in the air-bag during normal operation.
3.7
Counter-pulsation bed
A special bed used for external counter pulsation.
3.8
Counter-pulsation signal
Signal synchronized with cardiograph to control electromagnetic valve for charging and discharging air.
3.9
Air distributor system
A device composed of several electromagnetic valves and using counter-pulsation signal to control cut-off and get-through of operating air flow during counter pulsation.
3.10
Trigger wave
Cardiograph QRS waves that can trigger counter-pulsation signal (R wave is the trigger wave if available).
3.11
Air charging/discharging beginning time
The time from patient's cardiographic trigger wave (leading edge of simulative square wave during no counter pulsation) to the beginning of trigger signal for air charging/discharging during counter-pulsation treatment.
3.12
Pulse wave
Blood flow pulsatility diagram that can be detected by transducer at such positions as ear, neck, head and hand and can be used to monitor counter-pulsation effect.
3.13
Counter-pulsation rate
Proportion of counter-pulsation times to heart-beat times. 1:1 refers to one counter pulsation within every cardiographic cycle; 1:2 refers to one counter pulsation every two cardiographic cycles;
3.14
Worked normally
Screen has normal display, charging/discharging signal synchronizes with cardiograph and electromagnetic valve has normal operation under operating pressure.
4. Classification and Marking
No comments:
Post a Comment