Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
Dentistry — Stationary dental units and dental patient chairs — Part 1: General requirements
This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered. This document also specifies requirements for the instructions for use, for the technical description, for marking and for packaging. Operator's stools, portable dental equipment and operating lights are not in the scope of this document.
ISO 7494-1:2018 - Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements, defines requirements and test methods for stationary dental units, dental patient chairs and their combinations, whether electrically powered or not. The standard also covers required instructions for use, technical description, product marking and packaging. Operator’s stools, portable dental equipment and operating lights are explicitly out of scope.
The standard sets out general safety, performance and verification expectations for stationary dental equipment. Major areas include:
ISO 7494-1:2018 is used to:
Стандарты, упомянутые в описании
Key normative references include IEC 60601-1, IEC 80601-2-60, ISO 7494-2 (air/water/suction systems), ISO 10993-1 (biocompatibility), ISO 21530 (chemical resistance), ISO 11143 (amalgam separators), IEC 62366-1 (usability) and ISO 8191-1 (upholstery flammability).