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Technical rule [CURRENT]

VDI 5710 Blatt 1

Licensing and implementing of new nanotechnologies in the area of medical technology - Fundamentals
Edition 2019-07

Standards [CURRENT]

DIN EN 13641

Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts
Edition 2002-08

Standards [CURRENT]

DIN EN ISO 14889

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2013 + Amd 1:2017); German version EN ISO 14889:2013 + A1:2017
Edition 2018-04

Standards [CURRENT]

DIN EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011
Edition 2013-01

Standards [CURRENT]

DIN EN ISO 18113-2

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
Edition 2013-01

Standards [CURRENT]

DIN EN ISO 80601-2-70

Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020); German version EN ISO 80601-2-70:2020
Edition 2021-06

Draft standard

DIN EN ISO 18113-3

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021); German and English version prEN ISO 18113-3:2021
Edition 2021-09

Standards [CURRENT]

DIN EN 12470-1

Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device; German version EN 12470-1:2000+A1:2009
Edition 2009-11

Draft standard

DIN EN 16615

Chemical disinfectants and antiseptics - Quantitative test method for the evaluation of bactericidal and yeasticidal and/or fungicidal and/or tuberculocidal and/or mycobactericidal activity on non-porous surfaces with mechanical action employing wipes or mops in the medical area (4-field test) - Test method and requirements (phase 2, step 2); German and English version prEN 16615:2022
Edition 2022-12

Standards [CURRENT]

DIN EN ISO 15883-3

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006); German version EN ISO 15883-3:2009
Edition 2009-09

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