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| Certification |
An ISO Quality Management System is a means of "managing the business". Micro Medical Ltd can proudly announce that they now meet all of the requirements of ISO 9001:2000 - the premier quality standard.
ISO 9001:2000 is superior to all other standards in that it incorporates Design and Development control in addition to production and inspection controls.
Click the images below to view our certificates:
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| CE 120 |
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ISO 9001:2000 |
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ISO 13485:1996 |
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ISO 13485:1996 CMDCAS |
ATS (American Thoracic Society) Certification
We have received confirmation letters from the LDS Hospital inUtah that the MicroLab, MicroPeak,
SuperSpiro and the Micro DiaryCard have been validated to the latest ATS Spirometry Standards. The LDS Hospital is the recognised independent
testing centre in America which undertakes validation for all manufacturers who submit their spirometers. The current standard is the 1994
ATS Update. Many manufacturers claim conformity with
ATS Standards and some can prove validation to 1987 ATS Update. The
difference is very important. The 1994 ATS Update is the most stringent to date and requires manufacturers to supply instruments which meet,
apart from the 24 Standardised Spirometry Waveforms, a further 26 Peak Flow Waveforms, testing with heated and humidified
air and testing with human subjects.
The only way of validating the accuracy of a spirometer is to see the official letter of compliance to the latest Diagnostic ATS
standard from the LDS hospital in Utah. Without this compliance is extremely doubtful.
The LDS hospital is the ONLY recognised testing institution in the World
for testing spirometers.
This gives you the assurance that our claims of proven accuracy are backed up by vigorous independent testing.
We manage to ensure the accuracy of our instruments using Pulmonary Waveform Generators. Here at Micro Medical we have four PWG's including
the latest temperature and humidity controlled device. These are used for testing the accuracy of our instruments at development
level, calibrating at production level and ensuring reliability at Quality control. It is this persistence to pay attention to long
term accuracy and reliability that has given Micro Medical the World beating image that we have today and it is therefore no surprise
to know that Micro Medical produce the World's No.1 spirometer.
LDS Certificates
Read about the LDS Certificates
Electrical Certification
Our electrical certificates cover the following guidelines:
EN60601-1 Medical Electrical Equipment - General requirements for safety (IEC601-1)
EN60601-1-2 Medical Electrical Equipment - Electromagnetic compatibility
Click on the relevant product to see the electrical certification:
Our instruments have also been proven independently world-wide
in some of the harshest conditions available. Only a
turbine spirometer can ensure that continuous accuracy is maintained independent of altitude
or air pressure.
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