When precision matters – without risks or side effects When precision matters – without risks or side effects | HBM

When precision matters – without risks or side effects: SLS lifter scale

For exact dosages of medication corresponding to the patient's weight or pressure control during a heart/lung massage: Precise measurement results are a must in medical applications. Products used in this field are subject to especially high requirements because doctors, medical personnel and patients must be able to trust them at all times. That's why medical technology companies worldwide use HBM measurement technology. The SLS lifter scale is approved as a medical product and is one example of this.

The entire compact SLS lifter scale was developed by HBM together with manufacturers of patient lifters in 2005. The lifter manufacturers were responsible for evaluating the requirements derived from Directive 93/42/EEC (Medical Products Directive) for the scale in terms of safety. The scale itself was designed according to the current EC Directive 2009/23/EC as a legal-for-trade scale. Now HBM is responding to the lifter manufacturer's wish and taking responsibility for the scale as a medical product.

Certified as a medical product

Manufacturers of medical devices must comply with the Medical Devices Act (MPG - Medizinproduktegesetz) in Germany and Austria. This is the implementation into national law of Directive 93/42/EEC regarding medical devices. The directive known as the Medical Devices Act is one of three mandatory directives for medical products in the EU. It is the most important instrument for demonstrating the safety and reliability of the technical medical capability of medical devices in Europe.

To obtain approval of the lifter scale as a medical product, HBM demonstrated its suitability for use in a medical application in accordance with DIN EN 60601-1-6 and DIN EN 62366 (fitness for purpose as applied to medical devices). A risk analysis as per DIN EN 14971, an EMC test report as per DIN EN 60601-1-2 and EN45501/OIML R76 plus a clinical assessment were submitted. HBM also expanded its existing integrated management system to meet the requirements of EN ISO 13485:2003 + AC 2009 for medical devices. Implementation of the requirements in accordance with the standard for quality management system of medical devices was appropriately documented. And of course the company personnel involved in the production of the SLS lifter scale, approved in accordance with the Medical Devices Act 90/385/EEC, was also trained.

SLS sling scale