GB 8368-2018 Active National standards force_standard

GB 8368-2018 Infusion sets for single use—Gravity feed

GB 8368-2018 Infusion sets for single use—Gravity feed

Publish Date: 2018-03-15 Implement Date: 2021-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 8368-2018
Standard Type: National standards
Standard Status: Active
is_force_gb: yes
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2018-03-15
Implement Date: 2021-04-01
Pages: 25 pages

Scope

This standard specifies the marking, material, physical, chemical, and biological requirements for single-use gravity infusion pumps.
This standard applies to single-use gravity infusion pumps used in conjunction with infusion containers and venous devices.

Development Information

Word Count: 48 Thousand words Pages: 25 pages

Replace the following standards

Referenced Standards

GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods 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 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods GB 15811-2001 Sterile hypodermic needles for single use GB 15811-2016 Sterile hypodermic needles for single use GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness GB/T 25915.1-2021 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness by particle concentration YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements GB 15811-2025 Sterile hypodermic needles for single use GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

Adopt standards

ISO 8536-4:2010

Related Standards

Contact Us