of September 5, 2014 No. 880
About the list of the interconnected national standards
Based on article 20 of the Law on medical products No. 92 of April 26, 2012, and also based on Item 9 of the Regulations on the organization and functioning of the Ministry of Health approved by the Order of the Government No. 397 of May 31, 2011 I ORDER:
1. Approve:
The list of the interconnected national standards, according to appendix.
2. The list of the interconnected national standards is updated as required.
3. Publish this order in the Official monitor of the Republic of Moldova.
4. To impose control over execution of this order on the deputy minister Mr. Mikhail Chokana.
Minister of Health
Andrey Usaty
Appendix
to the Order of the Ministry of Health of the Republic of Moldova of September 5, 2014 No. 880
1. For implementation of the Regulations on the placement conditions in the market of medical products approved by the Order of the Government No. 418 of June 5, 2014
|
№ |
Standard |
Name |
|
1. |
SM SR EN 285+A2:2010 |
Sterilization. Steam sterilizers. Big sterilizers. |
|
2. |
SM SR EN 455-1:2010 |
Gloves are medical one-time. Part 1: Detection of openings. Requirements and testing. |
|
3. |
SM SR EN 455-2+A2:2012 |
Gloves medical one-time Part 2: Requirements and test methods of physical properties. |
|
4. |
SM SR EN 455-4:2012 |
Gloves medical one-time Part 4: Requirements and testing for determination of storage life. |
|
5. |
SM STB EN 556-1:2009 |
Sterilization of medical products. Requirements to the medical products marked "STERILELY". Part 1: Requirements to the medical products which are subject to finishing sterilization. |
|
6. |
SM SR EN 556-2:2010 |
Sterilization of medical products. Requirements to the medical products marked "STERILELY". Part 2: Requirements to the aseptic processed medical products. |
|
7. |
SM EN 794-3+A2:2014 |
"Anparaty for artificial ventilation of lungs. Part 3. Additional requirements to the devices for artificial ventilation of lungs used in case of emergency and in case of transportation of the patient"). |
|
8. |
SM SR EN 980:2010 |
The symbols used for marking of medical products |
|
9. |
SM SR EN 1041:2013 |
Information provided by the manufacturer of medical devices |
|
10. |
SM EN 1060-3+A2:2014 |
Sphygmomanometers noninvasive. Part 3. Additional requirements to electromechanical systems of measurement of pressure of blood. |
|
11. |
SMV EN 1060-4:2009 |
Sphygmomanometers noninvasive. Part 4. Procedures of testing for determination of accuracy of all system of automatic noninvasive sphygmomanometers |
|
12. |
SM EN ISO 1135-4:2014 |
Medical systems for transfusions. Part 4: One-time sets for intravenous injections. |
|
13. |
SMV EN 1282-2+A1:2009 |
Tubes trakheostomichesky. Part 2. Pediatric tubes. |
|
14. |
SM EN 1422:2014 |
Sterilizers of medical appointment. Sterilizers on the basis of ethylene oxide. Requirements and test methods. |
|
15. |
SM SR EN 1618:2010 |
Catheters, except intra vascular. Test methods of general properties. |
|
16. |
SM SR EN 1639:2011 |
Stomatology. Products are medical dental. Tools. |
|
17. |
SM SR EN 1640:2011 |
Stomatology. Products are medical dental. Equipment. |
|
18. |
SM SR EN 1641:2011 |
Stomatology. Products are medical dental. Materials. |
|
19. |
SM SR EN 1642:2013 |
Stomatology. Products are medical dental. Implants tooth. |
|
20. |
SM SR EN 1707:2010 |
Connections conic 6% (Lyuer) for syringes, needles and other medical equipment. Lock connections. |
|
21. |
SMV EN 1782:2009 |
Tubes trakhealny and connectors |
|
22. |
SM SR EN 1789+A1:2011 |
Transport medical and its equipment. Ambulance cars. |
|
23. |
SM EN 1820+A1:2014 |
Cylinders are respiratory, applied in case of anesthesia. |
|
24. |
SM EN 1865-3:2014 |
Transport medical and its equipment. Part 3: Stretcher. |
|
25. |
SM EN 1865-4:2014 |
Transport medical and its equipment. Part 4: Folding-chairs. |
|
26. |
SM EN 1865-5:2014 |
Transport medical and its equipment. Part 5: Supports under the Stretcher. |
|
27. |
SM SR EN 1985:2010 |
Supportive applications for walking. General requirements and test methods. |
|
28. |
SMV EN ISO 3826-2:2010 |
Plastic folding containers for human blood and components of blood. Part 2: Graphical symbols for use on labels and in instructions. |
|
29. |
SM EN ISO 3826-3:2014 |
Plastic folding containers for human blood and components of blood. Part 3: Systems of packets for blood with the built-in elements |
|
30. |
SM EN ISO 4074:2014 |
Condoms from natural latex. Requirements and test methods. |
|
31. |
SM EN ISO 4135:2014 |
Devices narcotic and respiratory. Dictionary |
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