BS EN ISO 23402-1:2020
$102.76
Dentistry. Portable dental equipment for use in non-permanent healthcare environment – General requirements
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 20 |
This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document.
This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions 4 Classification 4.1 General 4.2 For electrically operated devices 4.3 According to intended use environment |
| 11 | 4.4 According to supply sources 4.5 According to transport conditions 5 Requirements 5.1 General 5.2 Transport requirements 5.2.1 General |
| 12 | 5.2.2 Grips or other handling devices 5.2.3 Maximum mass 5.2.4 Maximum dimensions 5.2.5 Environmental exposure 5.2.6 Impact 5.2.7 Drop 5.2.8 Vibration 5.2.9 Particulate and liquid ingress during transport |
| 13 | 5.2.10 Flammability 5.3 Assembly and disassembly requirements 5.4 Utility requirements 5.5 Operational requirements 5.5.1 Ambient operating conditions 5.5.2 Usability 5.5.3 Applied parts not intended to supply heat to a patient |
| 14 | 5.5.4 Cleaning and disinfection of external surfaces 5.5.5 Noise 6 Sampling 7 Measurement and test methods 7.1 Visual inspection of the device 7.2 Visual inspection of the documentation 8 Manufacturer’s instructions 8.1 General |
| 15 | 8.2 Instructions for use 8.3 Technical description 9 Marking 9.1 Marking on the equipment 9.2 Marking of packaging |
| 16 | 10 Packaging |
| 17 | Annex A (informative) Applicable testing methodology from IEC 60601‑1:2005/Amd 1:2012 |
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ISO 23402-1:2020
Dentistry — Portable dental equipment for use in non-permanent healthcare environment — Part 1: General…
