FAQs - on Blood Bags and its Testing Picture: Pixabay Q. 1: Whether Blood Bags are notified under Medical Devices Rules 2017 ? Ans: Single, double, as well as quadruple Blood bags used for blood collection and component preparation are notified "Medical Devices" as per Medical Devices Rules 2017. Click for more articles on Medical Devices Q. 2: Where to purchase the Blood Bags from ? Ans: Blood centers has to purchase these blood bags from licensed dealers, distributors or manufacturer only. Q. 3: Whether every batch of Blood Bags is required to be tested ? Ans: 1. Yes, every batch of these blood bags required to be tested by the manufacturer of the blood bags 2. CoA of the blood bags supplied by the manufacturer is to be kept by the Blood Centres.3. Blood Centres has to follow SOP submitted to LA of the state regarding testing of blood bags Also read More FAQs, click here Q. 4: Where the Blood Bags are to be tested from ? Ans: Blood bag is to be tested from FDA Approved private Medical Device testing Laboratories only having approval under Medical Devices Rules 2017 on Form MD-40. Click to download MD-40 Q. 5: Whether Test report of Blood Bag on Form 39 is legal ? Ans: Test Reports issued on Form 39 by the drug testing Laboratories under Drugs and Cosmetics Rules 1945 is not legally valid. To read all FAQs of the author, click here Q. 6: ON which Form the Test report of Blood bag is to be issued ? Ans: The test report must be issued under Medical Devices Rules on Form MD-32. Clcik to download MD-32 Q. 7: Whether sterility testing of Whole Human Blood and its components are mandatory ? Ans: Yes, Whole Human Blood and its components are "Drug" and required to be tested for Sterility in addition to other tests. Also read More FAQs, click here Procedure to obtain license for Blood Centre (Blood Bank) Latest Notifications: Blood Centre / Bank Blood Centre (Bank) – requirements at a glance FAQs – on Blood Bank / Centre (Part-1) FAQs – on Blood Bank / Centre (Part-2) FAQs – on Blood Bank / Centre (Part-3) Blood Storage Centre Mandatory requirements for Blood donation camps FAQs on Legal Metrology & Blood Bags Bombay Blood Group Pharmacopoeial status of Blood and its components Your Guide to Preventing and Treating Blood Clots Adequate and safe blood transfusion for all: Article Why India needs more blood donors: Article
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