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EN ISO 7494-2:2015

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Dentistry - Dental units - Part 2: Air, water, suction and wastewater systems (ISO 7494-2:2015)
Withdrawn date

10-31-2015

Published date

04-08-2015

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Sampling
7 Tests
8 Manufacturer's instructions for use
9 Technical description
Annex A (informative) - Schematic diagram of possible
        components and connections in a dental unit
Annex B (informative) - Test sequences
Bibliography

ISO 7494-2:2015 specifies requirements and test methods concerninga) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,b) the materials, design, and construction of the compressed air and water system within the dental unit,c) the quality for incoming water and air, andd) the performance of dental unit suction system.ISO 7494-2:2015 also specifies requirements for instructions for use and technical description.ISO 7494-2:2015 is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in ISO 7494-2:2015.

Committee
CEN/TC 55
DevelopmentNote
Supersedes PREN ISO 7494-2 & EN ISO 11144. (04/2015)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn
Supersedes

DIN EN 1640:2010-02 Dentistry - Medical devices for dentistry - Equipment
BS EN 1640:2009 Dentistry. Medical devices for dentistry. Equipment
I.S. EN 1640:2009 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
UNI EN 1640 : 2010 DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
08/30184608 DC : DRAFT SEP 2008 BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT
BS EN 80601-2-60:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment
EN 80601-2-60:2015 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment

ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces
EN 1717:2000 Protection against pollution of potable water in water installations and general requirements of devices to prevent pollution by backflow
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 8573-1:2010 Compressed air Part 1: Contaminants and purity classes
ISO 1942:2009 Dentistry Vocabulary
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7494-1:2011 Dentistry Dental units Part 1: General requirements and test methods
ISO/TS 11080:2009 Dentistry Essential characteristics of test methods for the evaluation of treatment methods intended to improve or maintain the microbiological quality of dental unit procedural water
ISO 10637:1999 Dental equipment High- and medium-volume suction systems
ISO 11143:2008 Dentistry Amalgam separators

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