ISo9360 tests at TIM TestLab

ISO 9360 testing by certified 13485 TestLab for Heat and moisture exchanger (HMEs)

HME and HME-Filter Tests

...according to ISO 9360-1 or ISO 9360-2


Survey:


Based an standard requirement ISO 9360-1 and ISO 9360-2

Testing of Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 1: HMEs for use with minimum tidal volumes of 250 ml and esting of Anaesthetic and respiratory equipment -- Heat and moisture exchangers (HMEs) for humidifying respired gases in humans. Part 2: HMEs for use with tracheostomized patients

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Basic goals to achieve with HMEs

One of the main goals during development of a Heat and Moisture Exchanger or HME Filter is having a satisfying ability to store moisture. On the other hand development of HMEs could focus on a balanced resistance to flow ratio. For spontaneous breathing patients it is mandatory to ease breathing work as much as possible. For mechanical ventilated patients resistance also should be as low as possible to get best respiratoy care concept results when using the mandatory machine sided Heat and Moisture Exchanger. Of course - with moisture storing capacity in mind.

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Necessity of testing during development a hme

More Information or quoation needed:

Do not hesitate to contact us to get more information on Heat and moisture exchanger (HME) and HME-Filter. Or enquiry quotation for a very case.

Request quotation from certified test house.

Experience clearly shows that a testing of

  • materials inteded to be used with Heat and Moisture Exchangers
  • HME and filter material
  • HME housing form
  • material for the Heat and Moisture Exchanger housing
  • HME and filter material
  • interdependency of all hme components or
  • mutual reaction of some hme components or
  • combination of all hme or hme/filter components

in an early stage has become mandatory when thinking about a proper time-to-market time frame. To eliminate bad surprises in the final verfication and validation.

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HME: Marketing and Development goals

Depending on the marketing and/or the development strategy behind the HME or Heat and Moisture Exchanger Filter, a testing according to ISO 9360-1 or ISO 9360-2 also in an early stage is reasonable. An early stage testing according to the ISO 9360 standard can help to find out if development and marketing goals might be missed. Important questions based on materials and/or housing must be answered:

  • Will the HME pass the user requirements?
  • Will the HME pass the intended use?
  • Will the HME pass the specification requirements?
  • Will there be limitations?
  • Will there be problems?

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HME/Filter Testing in Verfication

Sustainable and reliable ISO 9360-1 and ISO 9360-2 testing and - the testing outcome - test reports are mandatory for successful products. Products with a long-term market and marketing strategy. HME Products accepted by clinicians and nursing staff. With a perfect user acceptence. And Heat and moisture products with a real benefit for the patient when used in respiratory care concepts in hospitals wordwide.

  • Will the HME pass the user requirements?
  • Will the HME pass the intended use?
  • Will the HME pass the specification requirements?
  • Will there be limitations?
  • Will there be problems?

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13485 certified test house at your side

HME ISO 9360 certified TestLab. By TÜV Nord certified according to ISO 13485:AC2012

A reliable partner therefore is needed. Experienced in ISO/standard testing. Testing of ventilation and anesthesia devices and - last but not least - airway management equipment.

  • Most HME types could be tested
  • Automated test bench
  • Over 25 years experience in testing
  • Certified 13485 company site

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More Information or quoation needed:

Do not hesitate to contact us to get more information on Heat and moisture exchanger (HME) and HME-Filter. Or enquiry quotation for a very case.

Request quotation from certified test house.
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  2. ISO 9360 tests acc. to the standard

    We perform your HME ISO 9360 tests. Fast and professional procession of your order.

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