- Abstract:This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
- Document number:DIN EN 61010-2-101; VDE 0411-2-101
- Issuing date:2018-04-01
- Document type:Norm-Entwurf
- Title:Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 66/644/CDV:2017); German and English version prEN 61010-2-101:2017
- Author:German Commission for Electrical, Electronic and Information Technologies of DIN and VDE
- Search term:Biological hazards; Control devices; Control equipment; Definitions; Diagnosis; Diagnostic equipment; Electric appliances; Electrical engineering; Hazards; In vitro; Laboratory apparatus; Laboratory medicine; Laboratory ware; Measuring instruments; Medical equipment; Protective measures; Risk analysis; Safety; Safety requirements; Specification (approval); Testing
- Application areas:09.05 Medizinische Geräte und Instrumente
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; CG Gefährdungsart: giftig; DA Mechanische Gefährdungen im Allgemeinen; EA Elektrische Gefährdungen im Allgemeinen
- ICS:11.100.10 In vitro diagnostic test systems
- Price:20,05 EUR
- Identical with:prEN 61010-2-101(2017-12)<IDT>; IEC 66/644/CDV(2017-12)<IDT>
- Update flag:Unchanged
- Deadline for comments:2018-05-09