Today's medical arena is more tightly regulated than ever before. Atlas Copco's medical air systems come pre-certified to simplify your certification process on installation.
Certificates and standards ensure that our medical equipment meets minimum requirements in safety and operating criteria. For example the HTM standard requires medical vacuum and medical air plants to have built-in redundancy and monitoring and alarm functions.
Atlas Copco designs its products to not only comply with these requirements, but also surpass them, without compromising on quality, reliability and consistent performance. Read more on regulations and how Atlas Copco deals with them in this article in Health Estate Journal:
Atlas Copco's medical air systems surpass the requirements of the most demanding standards and regulations such as:
- Medical Devices Directive MDD 93/42/EEC
- European pharmacopoeia
- EN ISO 7396-1
- ISO 14971
- Health Technical Memorandums HTM 02-01 and HTM 2022
Our PDp filters have been tested and certified by an external laboratory, proving that they can be considered as bacterial filters. Find the certificate for download below.
Our quality management systems for the design, manufacture, installation and testing of medical air and medical vacuum devices are according to:
- ISO 9001
- ISO 14001
- ISO 13485:2003 quality management system
With dedicated medical production facilities in three countries (Belgium, United Kingdom and United States), Altas Copco is ideally positioned to offer solutions in line with differentiating legislations.
Download some of these certificates below.