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Health Technology, Medical Equipment, Transfusion, Infusion and Injection Equipments, Blood Bag Standards, Blood Bag Standards

Since it has a direct impact on human life, we are transferring Transfusion, Infusion and Injection Equipment testing, inspection and certification services in this sector. Our company performs the testing, auditing and certification of all the standards mentioned below. 

 

TS 3521-1 EN 20594-1 Conical fittings for 6% (luer) thinning syringes used in medicine, needles and other medical materials Part 1-General features

TS EN ISO 7886-2 Disposable hypodermic syringe - Part 2: Syringes for use with a powered syringe pump

TS EN 1618 Catheters other than intravenous catheters- Test methods for common properties

TS EN 14820 Sample containers-For collecting human venous blood sample - One use

TS EN ISO 8871-2 Elastomeric parts for parenteral and pharmaceutical use devices - Part 2: Introduction and properties

TS EN ISO 8871-3 Elastomeric parts for parenteral and pharmaceutical use devices - Part 3: Determination of the number of particles released

TS EN ISO 8871-4 Elastomeric parts for parenteral and pharmaceutical use devices - Part 4: Biological properties and test methods

TS EN ISO 21649 Needle-free injectors for medical use - Properties and test methods 

TS EN ISO 8536-3 Medical use infusion equipment-Part 3: Aluminum caps for infusion bottles  

TS 3521-1 EN 20594-1 / AC Conical fittings, 6% (luer) taper - For syringes, needles and other medical materials used in medicine - Part 1: General characteristics

S EN ISO 8536-2 Infusion equipment for medical use - Part 2: Caps for infusion bottles  

TS EN ISO 8536-4 Infusion equipment for medical use - Part 4: Disposable infusion sets operating under the effect of gravity (ISO 8536-4: 2010)

TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable drugs (ISO 9187-1: 2010)  

TS EN ISO 9187-2 Injection equipment for medical use-Part 2: Single point cut (TNK) ampoules (ISO 9187-2: 2010) +

TS EN ISO 8362-6 Injection containers and accessories-Part 6: Caps made of aluminum-Plastic combinations for injection vials 

TS EN ISO 9187-1 Injection equipment for medical use - Part 1: Ampoules for injectable drugs  

TS EN ISO 9187-2 Injection equipment for medical use-Part 2: Single point cut (opc) ampoules

TS EN 60601-2-41 / A11 Electrical medical equipment - Part 2-41: Specific features regarding the basic safety and required performance of lighting fixtures used in surgical procedures and diagnosis 05.06.2012 11.040.20

TS EN ISO 8362-4 Injection containers and accessories - Part 4: Injection bottles made of molded glass 

TS EN ISO 8536-1 Infusion equipment for medical use - Part 1: Glass infusion bottles