Infusion access adapter - Part 2: Needleless access adapters English
1 Scope
This part of YY 0581 specifies the requirements and test methods of needless automatic closed access adapters (hereinafter referred to as access adapters) for single use.
This part may be referred to by the access adapter products, which are integrated with intravascular indwelling devices (such as intravenous indwelling needles).
The backflow preventers specified in YY 0286.6 are excluded from the scope of this part.
The switches specified in YY 0585.2 are excluded from the scope of this part.
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 8368 Infusion sets for single use - Gravity feed
GB 15810 Sterile syringes for single use
GB 15811 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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
positive displacement
flowing of the liquid in the system towards the body on the moment the infusion equipment is pulled out from the access port to avoid blood backflow due to pulling out the infusion equipment
3.2
access port
liquid inlet port composed of sealing components on the access adapter, which are applicable to be accessed to conical lock fitting with a 6% (Luer) taper of infusion equipment, with the expected sealing property during access and after separation
Note: Different from the backflow preventer, the adapted access port may make the liquid flow backward and forward.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Evaluation of microorganism invasion
9 Packaging
10 Marking
Annex A (Normative) Physical test
Annex B (Normative) Chemical test
Annex C (Informative) Clinical implication and method guide of microorganism invasion test of needleless access adapters
Bibliography
