DANSK DS/EN ISO 11197 PDF

201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site. NOTE – The definition of a MANUFACTURER and guidance on assembly on site can be found in ISO 14971 and ISO 13485. HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE – See also 4.2 of the General Standard.