Package has 5 documents
EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package
EN 62366, EN ISO 14971, EN 1041 And ISO 10993-1 (EU Standard)
EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package specifies the process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device. It also provides risk management application, evaluation and testing associated with medical devices.
EN 62366 / EN ISO 14971 / EN 1041 / ISO 10993-1 - Medical Devices Package includes:
- EN 1041:2008+A1:2013
- EN 10993-1:2018
- EN 62366-1:2015+A1:2020
- EN ISO 14971:2019
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Package has 5 documents
General Information
Standard
EN 1041:2008
English language
25 pages
Standard
EN 1041:2008+A1:2013
English language
26 pages
Standard
EN 62366-1:2015
English language
53 pages
Standard
EN ISO 14971:2020
English language
46 pages
Standard
ISO 10993-1:2018 - Biological evaluation of medical devices
English language
41 pages