NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 21535 [CURRENT] references following documents:

Document number Edition Title
ASTM F 561 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids More 
DIN EN ISO 10993-1 2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More 
DIN EN ISO 21534 2009-08 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2009 More 
DIN ISO 5834-1 2020-07 Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form (ISO 5834-1:2019) More 
EUV 2017/745 2017-04-05 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More 
ISO 13179-1 2021-09 Implants for surgery - Coatings on metallic surgical implants - Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders More 
ISO 13779-2 2018-12 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite More 
ISO 17853 2011-03 Wear of implant materials - Polymer and metal wear particles - Isolation and characterization More 
ISO 5832-12 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy More 
ISO 5832-3 2021-11 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy More