ISO 6875 pdf download Dentistry — Patient chair
1 Scope
This International Standard is applicable to all patient chairs, regardless of their construction, and regardless ofwhether they are operated manually, electrically or by other means, or as a combination of these.
This International Standard specifies requirements, test methods,manufacturer’s information,markingand packaging.
2 Normative references
The following referenced documents are indispensable for the application of this document.For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.
ISO 1942,Dentistry – Vocabulary
ISO 4073,Dentistry — Information system on the location of dental equipment in the working area of the oralhealth care provider
ISo 8191-1,Furniture — Assessment of the ignitability of upholstered furniture — Part 1: lgnition source:smouldering cigarette
IsO 9687,Dental equipment — Graphical symbols
ISO 21530,Dentistry — Materials used for dental equipment surfaces —Determination of resistance tochemical disinfectants
ISO/IEC 80601-2-60:2011, Medical electrical equipment— Part 2-60: Particular requirements for basic safetyand essential performance of dental equipment
IEC 60601-1:2005,Medical electrical equipment — Part 1: General requirements for basic safety andessential performance
IEC 62366, Medical devices — Application of usability engineering to medical devices
IEC 62353,Medical electrical equipment —Recurrent test and test after repair of medical electrical equipment
3Terms and definitions
For the purposes of this document, the terms and definitions given in lSO 1942,IS0 4073, IEC 60601-1 andISO/IEC 80601-2-60 and the following apply.
3.1
patient chair
device equipped with a range of movements, designed to support and position the patient for dental treatment
4 Classification
4.1General
This classification applies to electrically operated patient chairs only.
4.2 According to type of protection against electric shock
Patient chairs are classifed in accordance with IEC 60601-1 as follows:
a) Class I equipment, see IEC 60601-1:2005, 3.13.
b) Class II equipment, see IEC 60601-1:2005, 3.14.
4.3 According to degree of protection against electric shock
If a patient chair has an applied part it shall be classifed as Type B, see IEC 60601-1:2005, 3.132.
4.4 According to mode of operation
IEC 60601-1:2005, 6.6 applies.
NOTE Patient chairs are intended for non-continuous operation.
5 Requirements
5.1 General requirements
5.1.1 Electrical requirements
Electrical requirements are only applicable to electrically operated patient chairs. There are, however, general requirements given in IEC 60601-1, which are also applicable to non-electrical patient chairs.
IEC 60601-1 and ISO/IEC 80601-2-60 apply.
5.1.2 Moving parts
IEC 60601-1:2005, 9.2 applies.
Testing shall be carried out in accordance with 7.2.1.
5.1.3 Operating controls
Operating controls shall be designed and located to minimize accidental activation. Graphical symbols for operating controls and performance shall be in accordance with ISO 9687.
IEC 60601-1:2005, 15.1 applies.
5.1.4 Usability
Testing shall be carried out in accordance with IEC 62366.
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