ISO 11197:2019
Medical supply units
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document 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 document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
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201.1 Scope, object and related standards
201.1.1 Scope
201.1.2 Object
201.1.3 Related standards
201.1.3.1 General and Collateral standards
201.1.3.2 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents
201.8 Protection against electrical hazards from ME equipment
201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions
201.13.2.2 Single fault conditions
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and essential performance — Collateral standard: Usability
Annex A A (informative) Rationale
Annex B B (informative) Tests during production
Annex C C (informative) Documentation
Annex D D (informative) Terminology — Alphabetical index of defined terms
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201.1 Scope, object and related standards
201.1.1 Scope
201.1.2 Object
201.1.3 Related standards
201.1.3.1 General and Collateral standards
201.1.3.2 Particular standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents
201.8 Protection against electrical hazards from ME equipment
201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions
201.13.2.2 Single fault conditions
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and essential performance — Collateral standard: Usability
Annex A A (informative) Rationale
Annex B B (informative) Tests during production
Annex C C (informative) Documentation
Annex D D (informative) Terminology — Alphabetical index of defined terms
Blank Page