Standard Swedish standard · SS-EN ISO 11197:2016

Medical supply units (ISO 11197:2016)

Status: Withdrawn

· Replaced by: SS-EN ISO 11197:2019
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Standard Swedish standard · SS-EN ISO 11197:2016

Medical supply units (ISO 11197:2016)
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Scope
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

Subjects

General (11.040.01) Anaesthetic, respiratory and reanimation equipment (11.040.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 11197:2016

Medical supply units (ISO 11197:2016)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-8019406

Edition: 3

Approved: 3/14/2016

No of pages: 44

Replaces: SS-EN ISO 11197:2009

Replaced by: SS-EN ISO 11197:2019