BS EN ISO 8536‑4:2020 pdf download.Infusion equipment for medical use.
3 Terms and definitions
No terms and definitions are listed in this document.
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5 Designation
Designation shall follow label requirements according to Clause 10.
6 Materials
The materials from which the infusion set, its components and the stand‑alone air‑inlet device are
manufactured (as described in Clause 4) shall comply with the requirements specified in Clause 7.
Where components of the infusion set come into contact with solutions, the materials shall also comply with the requirements specified in Clauses 8 and 9.
7 Physical requirements
7.1 Particulate contamination
The infusion set and stand‑alone air‑inlet device shall be manufactured under conditions that minimize particulate contamination. All parts shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.2, the number of particles shall not exceed the contamination index limit.
7.2 Leakage
The infusion set, when tested in accordance with A.3, shall show no signs of air leakage.
7.3 Tensile strength
When tested as specified in A.4, the infusion set, excluding protective caps, shall withstand a static tensile force of not less than 15 N for 15 s.
7.4 Closure‑piercing device
The dimensions of the closure‑piercing device shall conform to the dimensions shown in Figure 4. The cross‑section of the closure‑piercing device over the length of 15 mm shall be a circle.
NOTE The dimension of 15 mm in Figure 4 is a reference measurement.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container without pre‑piercing. No coring should occur during this procedure.
7.5 Air‑inlet device The air‑inlet device can be an integral part of the infusion set (Figure 1) or a stand‑alone device (Figure 3). The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the container into which the device is to be inserted. When the air‑inlet device is in use the air admitted into the container shall not become entrained in the liquid‑entry of the closure‑piercing device. The air filter and the design of the air-inlet device shall be such that all air entering the rigid container passes through it, and such that the flow of fluid is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with A.5.2 and A.5.3. The closure‑piercing device or needle of the stand‑alone device shall be capable of piercing and penetrating the closure of a fluid container without pre-piercing. No coring should occur during this procedure.BS EN ISO 8536‑4 pdf download.