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DIN EN 62366-1

Medical devices - Part 1: Application of usability engineering to medical devices

Technology

Material

Use of Standart

specification

Branch

Medical, Medical Devices

ISO 10993-3:2014

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Technology

Material

Use of Standart

guideline

Branch

Medical, Medical Devices

EN ISO 10993-1:2021

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Technology

Material

Use of Standart

guideline, test method

Branch

Medical, Medical Devices

EN 1642:2012-06

Dentistry - Medical devices for dentistry - Dental implants

Technology

Material

Use of Standart

guideline, specification

Branch

Medical, Medical Devices

EN ISO 10993-18:2021-03

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process

Technology

Material

Use of Standart

characterisation, test method

Branch

Medical, Medical Devices

EN 1641:2009

Dentistry - Medical devices for dentistry - Materials

Technology

Material

Use of Standart

characterisation, data sheets, guideline

Branch

Medical, Medical Devices

IEC 62304:2006

Medical device software — Software life cycle processes

Technology

not technology-specific

Material

Use of Standart

guideline, qualification, specification

Branch

Medical, Medical Devices

EN ISO 15223-1

Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements

Technology

Material

Use of Standart

specification

Branch

Medical, Medical Devices

DIN EN ISO 14971

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Technology

Material

Use of Standart

certification, characterisation, guideline, personal qualification, qualification, specification

Branch

Medical, Medical Devices

DIN EN ISO 10271

Dentistry - Corrosion test methods for metallic materials

Technology

Material

Use of Standart

characterisation, test method

Branch

Medical, Medical Devices

EN ISO 13485

Medical devices — Quality management systems — Requirements for regulatory purposes

Technology

Material

Use of Standart

certification, guideline, qualification

Branch

Medical, Medical Devices

EN ISO 14155

Clinical investigation of medical devices for human subjects - Good clinical practice

Technology

Material

Use of Standart

guideline

Branch

Medical, Medical Devices

ISO 14971

Medical devices — Application of risk management to medical devices

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline, qualification

Branch

Medical, Medical Devices

DIN EN ISO 10328

Structural testing of lower-limb prostheses – Requirements and test methods

Technology

not technology-specific

Material

not material specific

Use of Standart

qualification

Branch

Prosthesis

DIN EN ISO 22523

External limb prostheses and external orthoses – Requirements and test methods

Technology

not technology-specific

Material

not material specific

Use of Standart

certification, guideline, qualification

Branch

Orthoses

DIN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

Technology

not technology-specific

Material

not material specific

Use of Standart

certification

Branch

Medical Devices

WK 60265

New Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

Technology

Powder Bed Fusion

Material

Metals

Use of Standart

guideline

Branch

Medical

ISO/ASTM TR 52916:2022

Additive manufacturing for medical — Data — Optimized medical image data

Technology

not technology-specific

Material

not material specific

Use of Standart

specification

Branch

Medical

ISO 11491:2017-07

Geometrische Produktspezifikation (GPS) - Geometrische Tolerierung - Tolerierung von Form, Richtung, Ort und Lauf (ISO 1101:2017)

Technology

not technology-specific

Material

Ceramics

Use of Standart

test method

Branch

Medical

IEEE P3333.2.5

Standard for Bio-CAD File Format for Medical Three-Dimensional (3D) Printing

Technology

not technology-specific

Material

not material specific

Use of Standart

guideline

Branch

Medical

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