Detaljer om förslaget

201.1 Scope, object and related standards Clause 1 of the general standard1) 229 applies, except as follows: 230 201.1.1 * Scope 231 Replacement: 232 This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of 233 MEDICAL BEDS as defined in 201.3.214, intended for ADULTS as defined in 201.3.222. Included 234 in scope are both electrical and non-electrical (manual) MEDICAL BEDS with or without 235 adjustable features. 236 This standard does not apply for MEDICAL BEDS intended for CHILDREN covered by IEC 80601- 237 2-89 Medical electrical equipment – Particular requirements for the basic safety and essential 238 performance of medical beds for children. 239 A BED-LIFT and/or a detachable MATTRESS SUPPORT PLATFORM in combination with a compatible 240 non-MEDICAL BED as specified by the MANUFACTURER is also considered a MEDICAL BED. 241 Excluded are devices for which the intended use is mainly for examination or transportation 242 under medical supervision (e.g. stretcher, examination table). 243 This standard does not apply in all requirements to MEDICAL BEDS with special functionality. 244 Beds that are intended to be used for ADULTS with atypical anatomy shall state what atypical 245 anatomies are meant. Additional requirements for the stated atypical anatomies shall be 246 determined in the product RISK MANAGEMENT process and implemented as appropriate in the 247 bed design. 248 EXAMPLE A bed intended for bariatric PATIENTS would require consideration of the differences in anthropomorphic 249 ranges, and having implemented those ranges would label appropriately for the intended PATIENT population. 250 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to 251 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the 252 case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. 253 HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within 254 the scope of this standard are not covered by specific requirements in this standard except in 255 7.2.13 and 8.4.1 of the general standard.