ISO 11197:2016
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical supply units
Hardcopy , PDF
French, English
11-02-2016
09-04-2025
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.
ISO 11197:2016 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.
| Committee |
ISO/TC 121/SC 6
|
| DevelopmentNote |
DRAFT ISO/DIS 11197 is also available for this standard. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
29
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 11197:2016 | Identical |
| SS-EN ISO 11197:2016 | Identical |
| NS EN ISO 11197 : 2016 | Identical |
| DIN EN ISO 11197 : 2016 | Identical |
| NEN EN ISO 11197 : 2016 | Identical |
| NBN EN ISO 11197 : 2016 | Identical |
| EN ISO 11197:2016 | Identical |
| BS ISO 11197 : 2016 | Identical |
| PN EN ISO 11197 : 2016 | Identical |
| VDE 0750-211 : 2016 | Identical |
| NF EN ISO 11197 : 2016 | Identical |
| BS EN ISO 11197:2016 | Equivalent |
| UNE-EN ISO 11197:2016 | Identical |
| BS EN ISO 11197:2009 | Identical |
| BS EN ISO 11197:2016 | Identical |
A newer version of this standard is available.
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