GB 8369.1-2019 Transfusion sets for single use—Part 1: Gravity feed

Scope: This part of GB8369 specifies the material, physical, chemical and biological requirements for single-use, gravity-fed medical blood transfusion sets. This section applies to single-use, gravity-fed blood transfusion sets used in conjunction with blood and blood component containers and pulse sets.

GB 15811 Sterile hypodermic needles for single use
GB/T 14232.2 Bag plastic containers for human blood and blood components - Part 2: Graphical symbols for labeling and instructions for use
GB/T 14233.1 Test methods for infusion, transfusion, injection equipments for medical use—Part 1: Chemical analysis methods*， 2022-10-14 Update
GB/T 14233.2 Test methods for infusion,transfusion,injection equipment for medical use.Part 2:Biological test methods
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
GB/T 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
GB/T 1962.2-2001 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
GB/T 25915.1 Cleanrooms and associated controlled environments—Part 1: Classification of air cleanliness by particle concentration*， 2021-08-20 Update
GB/T 6682-2008 Water for analytical laboratory use.Specification and test methods
ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
ISO 7864:1993 Sterile hypodermic needles for single use
YY/T 0466.1 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements

GB 8369.1-2019 Transfusion sets for single use—Part 1: Gravity feed has been changed from GB 8369-2005 Transfusion sets for single use.

GB 8369.1-2019Transfusion sets for single use—Part 1: Gravity feed