EN 12182

Assistive products for persons with disability

As a European level 1 standard, the document contains requirements and test methods of general application for technical aids for persons with a disability, which are also classified as medical devices. In the case of conformity, the manufacturer can provide evidence (proof) that the essential requirements of EU Directive 93/42 / EEC (Annex I) are met. If Level 2 or 3 standards define specific requirements for a product group, the general requirements shall be supplemented, modified or replaced by the specific requirements.