Nebulizers in home health-care: Additional requirements with regard to product standardization
article
As result of new European legislation many standards have been developed recently or are currently under development. These standards are based on the Medical Device Directive (MDD) 93/42/EEC. One of the standards under development is 'Nebulizing Systems' by Technical Committee TC 215 of CEN, the European standardization body. In the past quality guidelines have been developed because international standards were not available for the majority of products. In addition, the home health-care situation can pose several demands different from those that occur in hospitals. The Netherlands Organization for Applied Scientific Research (TNO) quality guideline 'Nebulizers in Home Health Care' was published in July 1994. Important aspects covered by this guideline are functional aspects such as measurement of the size distributions of the aerosol particles, cleaning aspects, technical aspects such as electrical safety and electromagnetic susceptibility, durability, ergonomics, instruction and service aspects. The cleaning aspects of the guideline include the effectiveness of cleaning, the residue of cleaning agent after cleaning and resistance to cleaning agents. This guideline will be rewritten in relation to the Medical Device Directive, the future European Committee for Standardization (CEN) standard Nebulizing Systems, covering the technical and functional requirements, and the future quality guideline for health-care suppliers, covering the service requirements.
Topics
TNO Identifier
235374
ISSN
09059180
Source
European Respiratory Review, 10(72), pp. 220-223.
Pages
220-223
Files
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