EMC China Lab

Which products require ISO 18562 testing?

Views :
Update time : 2024-08-07

Since August 2018, all medical devices, components, or accessories containing gas pathways, where the gas can be inhaled by the user—such as ventilators, oxygen concentrators, anesthesia machines, nebulizers, breathing tubes, and respiratory masks—must provide an ISO 18562 series standard testing and assessment report when applying for FDA registration.

 Which products require ISO 18562 testing?(图1)

ISO 18562 includes the following four standards:

1. ISO 18562-1: Biocompatibility evaluation of breathing gas pathways in medical devices - Part 1: Evaluation and testing within a risk management process.

2. ISO 18562-2: Biocompatibility evaluation of breathing gas pathways in medical devices - Part 2: Particle emission testing.

3. ISO 18562-3: Biocompatibility evaluation of breathing gas pathways in medical applications - Part 3: Volatile organic compounds (VOC) emission testing.

4. ISO 18562-4: Biocompatibility evaluation of breathing gas pathways in medical applications - Part 4: Extractables testing from condensates.

 

Products applicable for ISO 18562 include but are not limited to:

- Anesthesia machines and anesthesia workstations (including gas mixers);

- Oxygen concentrators, oxygen storage devices, and oxygen concentrators;

- Ventilators, nebulizers, sprayers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, masks, and resuscitators;

- Respiratory systems, respiratory gas monitors, respiratory monitors, breathing tubes, respiratory system filters, Y-connectors, and any respiratory accessories intended for use with such medical devices.

 

China JJR Laboratory is an IEC 17025 and GLP accredited laboratory that offers iso 18562 testing services. Located in China, the laboratory can help you save 30% on testing costs. Please contact us for a quote."ISO 18562 COST"


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
How to get the Amazon SOR/2016-169 Test Report? How to get the Amazon SOR/2016-169 Test Report?
03 .20.2025
To sell children‘s sleepwear on Amazon Canada, SOR/2016-169 testing is required. JJR Laboratory prov...
How to get the UL 1559 Test Report? How to get the UL 1559 Test Report?
03 .20.2025
To sell mosquito killer lamps in North America, a UL 1559 test report from JJR Laboratory is require...
How to get EN 12790 Test Report? How to get EN 12790 Test Report?
03 .20.2025
Get an EN 12790 test report, submit a product sample to JJR Lab for testing. The report ensures comp...
What are the Amazon ASTM F1004 and 16 CFR 1239 Tes What are the Amazon ASTM F1004 and 16 CFR 1239 Tes
03 .20.2025
Amazon requires child safety gates to meet ASTM F1004 & 16 CFR 1239 standards, including lead li...
How to get a UL2056 Test Report? How to get a UL2056 Test Report?
03 .20.2025
JJR Lab provides UL2056 testing for portable power banks, ensuring safety in overcharge, short-circu...
USB-C Port Korea KC EMC Certification USB-C Port Korea KC EMC Certification
03 .20.2025
From Feb 14, 2025, USB-C products need KC-EMC certification in Korea; laptops from Apr 1, 2026. Cove...
In-Vehicle DAB Product Certification Standards In-Vehicle DAB Product Certification Standards
03 .20.2025
In-vehicle DAB products must meet various global standards for market access. JJR Laboratory provide...
Outdoor Surveillance Equipment Protection Level Te Outdoor Surveillance Equipment Protection Level Te
03 .20.2025
JJR Laboratory offers protection level testing for outdoor surveillance equipment, ensuring durabili...

Leave Your Message