This Decision promulgates 10 industry standards for medical equipment applicable to healthcare facilities and enterprises producing medical equipment. These standards specify the technical quality of products such as sterile hand washing units, vaginal speculums, cervical forceps, vaginal dilators, tissue clamps, and surgical knife handles.
适用范围
Healthcare facilities and enterprises producing medical equipment
要点
- Healthcare facilities and enterprises producing medical equipment must comply with 10 industry standards regarding the technical quality of products such as sterile hand washing units, vaginal speculums, cervical forceps, vaginal dilators, tissue clamps, and surgical knife handles.
- This Decision takes effect fifteen days from the date of signature.
🌐 本文件的社会影响
- Positive impact: Ensuring the quality of medical equipment, enhancing safety and effectiveness during diagnosis and treatment.
- Negative impact: May increase investment costs for healthcare facilities and manufacturing enterprises.
❓ 常见问题
Which types of medical equipment does this industry standard apply to?
This industry standard applies to ten types of medical equipment including sterile hand washing units, vaginal speculums, cervical forceps, vaginal dilators, tissue clamps, and surgical knife handles.
When does this Decision take effect?
This Decision takes effect fifteen days from the date of signature.
What standards must healthcare facilities and enterprises producing medical equipment comply with?
Healthcare facilities and enterprises producing medical equipment must comply with 10 industry standards concerning the technical quality of products such as sterile hand washing units, vaginal speculums, cervical forceps, vaginal dilators, tissue clamps, and surgical knife handles.
How does this Decision affect the investment costs of healthcare facilities and enterprises?
This Decision may increase investment costs for healthcare facilities and manufacturing enterprises to ensure compliance with new industry standards.
When were these industry standards promulgated?
These industry standards were promulgated along with Decision No. 1629/2001/QD-BYT dated May 23, 2001.
全文
Pursuant to …;
Regarding the issuance of 10 Industry Standards for Medical Equipment
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THE MINISTER OF HEALTH
Pursuant to Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to the Quality of Goods Ordinance dated January 4, 2000;
Based on the proposals of the Heads of the Science and Training Department, the Medical Equipment and Health Works Department.
DECISION:
Article 1: Issued together with this Decision are the Industry Standards for 10 medical equipment products (with attached list).
Article 2: THIS DECISION SHALL TAKE EFFECT 15 DAYS FROM THE DATE OF SIGNATURE.
Article 3: The Director of the Office, Heads of the Science and Training Department, Medical Equipment and Health Works Department - Ministry of Health, Director of the Institute of Medical Equipment and Health Works, Heads of related units shall be responsible for implementing this Decision./.
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DEPUTY MINISTER OF HEALTH |
LIST
10 INDUSTRY STANDARDS FOR MEDICAL EQUIPMENT
(Issued together with Decision No. 1629/2001/QĐ-BYT dated May 23, 2001)
1. 52 TCN - TTB 0002 : 2001 Sterile Hand Washing Unit
2. 52 TCN - TTB 0003 : 2001 Cusco-type Vaginal Speculum
3. 52 TCN - TTB 0004 : 2001 Grave-type Vaginal Speculum
4. 52 TCN - TTB 0005 : 2001 Two-pronged Uterine Clamp
5. 52 TCN - TTB 0006 : 2001 Bozeman-type Disinfection Clamp
6. 52 TCN - TTB 0007 : 2001 Vas Deferens Retaining Clamp
7. 52 TCN - TTB 0008 : 2001 Allis Tissue Forceps
8. 52 TCN - TTB 0009 : 2001 Single-ended Vaginal Dilator
9. 52 TCN - TTB 0010 : 2001 Double-ended Vaginal Dilator
10. 52 TCN - TTB 0011 : 2001 Handle for Scalpel Nos. 3 and 4
关系图
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