This standard specifies the marking, material, physical, chemical and biological requirements of gravity feed infusion set for single use.
This standard specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
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; ISO 594-2:1998, IDT)
GB/T 6682 Water for analytical laboratory use - Specification and test methods (GB/T 6682-2008, ISO 3696:1987, MOD)
GB/T 14233.1-2008 Test methods for infusion transfusion injection equipment for medical use - Part 1: Chemical analysis methods
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
GB 15811 Sterile hypodermic needles for single use (GB 15811-2016, ISO 7864:1993, NEQ)
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2011, ISO 10993-1, 2009, IDT)
GB/T 25915.1 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (GB/T 25915.1-2010, ISO 14644-1:1999, IDT)
YY/T 0466.1 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, 1SO 15223-1:2012, IDT) 2012, IDT)
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 are used for collapsible plastic containers. Infusion sets as illustrated in Figure 2 used with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, are used for rigid containers.
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.
Keys:
1——protective cap of closure-piercing device;
2——closure-piercing device;
3——air inlet with air filter and closure;
4——fluid channel;
5——drip tube;
6——drip chamber;
7——fluid filter;
8——tubing;
9——flow regulator;
10——injection site;
11——male conical fitting;
12——protective cap of male conical fitting.
a Closure of the air inlet is optional.
b The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has a nominal pore size of 15 μm.
