Sökning - 3 resultat för '344'

Ämnesområden: Medicinsk utrustning
Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 17 maj 2024
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 201.1.1 * Scope 243 Replacement: 244 This standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, 245 hereafter referred to as MEDICAL BEDS as defined in 201.3.219, intended for CHILDREN as defined 246 in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for 247 ADULTS in 201.3.201). 248 This standard applies to electrical or non-electrical MEDICAL BEDS with nonadjustable and 249 electrical / mechanical adjustable functions. 250 This standard applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a 251 body length of 155 cm. 252 NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with 253 the child or that the bed will be used by an ADULT. 254 If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. 255 INTERNAL LENGTH of 180 cm or more, then it shall fulfil both IEC 80601-2-52 and this particular 256 standard. 257 This Standard does not apply to: 258 • ADULT only beds covered by IEC 80601-2-52 259 • incubators covered by IEC 60601-2-19; 260 • devices for which the INTENDED USE is mainly for examination or transportation under 261 medical supervision (e.g. stretcher, examination table). 262 If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME 263 SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, 264 the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. 265 HAZARDS inherent in the intended physiological function of MEDICAL BEDS or ME SYSTEMS within 266 the scope of this standard are not covered by specific requirements in this standard except in 267 7.2.13 and 8.4.1 of the general standard. 

Ämnesområden: Medicinsk utrustning
Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: ISO
Svarsdatum: den 17 maj 2024
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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. 

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 10 jun 2024
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This document defines standards for the training of assistance dogs. Assistance dogs may be trained by structured programmes/schools, owner-trained under supervision or ownertrainers. Specifically, this document deals with the following topics: - Preparation of assistance dogs - Socialization and puppy raising of assistance dogs - Training of assistance dogs - Guide Dogs - Hearing Dogs - Mobility Assistance Dogs - PTSD Assistance Dogs - Medical Alert Response Assistance Dogs - Autism and Developmental Disorder Assistance Dogs - Dual Purpose Assistance Dogs