UNE-EN ISO 11197:2020
Current
The latest, up-to-date edition.
Medical supply units (ISO 11197:2019)
Hardcopy , PDF
Spanish, Castilian, English
14-10-2020
201.1.1 ScopeIEC 60601-1:2005+A1:2012, 1.1 is replaced by: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, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.NOTE 1 A party that assembles on site various components intended for PATIENT care services into an ENCLOSURE is considered the MANUFACTURER of the MEDICAL SUPPLY UNIT.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 IEC 60601-1:2005+A1:2012 (see 201.1.4).NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.201.1.2 ObjectIEC 60601-1:2005+A1:2012, 1.2 is replaced by:The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MEDICAL SUPPLY UNITS as defined in 201.3.103.
| Committee |
CTN 110
|
| DocumentType |
Standard
|
| Pages |
47
|
| ProductNote |
THIS STANDARD ALSO REFERS:ISO 19054
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| BS 3261-1:1973 | Identical |
| EN ISO 11197:2019 | Identical |
| ISO 11197:2019 | Identical |
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