“We (BSN) expect this regulation to be applied by local producers, experts, and other stakeholders to keep innovating to fulfill the rising oxygen demand and improve the competitiveness of the industry amid this COVID-19 pandemic,” standard development acting deputy at BSN, Donny Purnomo, said here on Friday.
“It (The regulation) does not aim to supervise domestic circulation of imported medical gas products since the supervision can be conducted by giving requirements for the importers to meet the origin or international standards,” he added.
The jump in the number of COVID-19 patients in the second wave of the pandemic has led to a rise in the demand for medical oxygen, medical gas cylinders, regulators, flow meters, as well as oxygen concentrators, he said. Hence, the BSN is trying to identify international standards that can be adopted as SNI, he added.
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He said nine international standards will be adopted under the medical gases SNI:
1. ISO 10524-1:2018 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices;
2. ISO 10524-3:2018 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs);
3. ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators.
4. ISO 9809-1:2019 Gas cylinders - Design, construction and testing of refillable seamless steel gas cylinders and tubes - Part 1: Quenched and tempered steel cylinders and tubes with tensile strength less than 1,100 MPa;
5. ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems;
6. ISO 9809-2:2019 Gas cylinders - Design, construction and testing of refillable seamless steel gas cylinders and tubes - Part 2: Quenched and tempered steel cylinders and tubes with tensile strength greater than or equal to 1,100 MPa;
7. ISO 9809-3:2019 Gas cylinders - Design, construction and testing of refillable seamless steel gas cylinders and tubes - Part 3: Normalized steel cylinders and tubes;
8. ISO 80601-2-69:2020 Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment; and,
9. ISO 80601-2-67:2020 Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment.
As the first step, BSN said it will establish an SNI Formulation Technical Committee along with experts. After the committee is formed, a technical or consensus meeting will take place through the Republication Reprinted Adoption method. Then, a survey will be conducted for 20 days. Finally, the targeted SNI will be rolled out by the end of August, 2021, Purnomo said.
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