AAMI TIR57:2016(R2019)
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Principles for medical device security—Risk management
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
03-09-2019
Superseded date
27-11-2023
Superseded by
€242.57
Excluding VAT
This Technical Information Report (TIR) provides guidance on methods to perform information security risk management for a medical device in the context of the Safety Risk Management process required by ISO 14971.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-612-2
|
| Pages |
84
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| ITU-T FG-AI4H DEL2.2:2022 | Good practices for health applications of machine learning: Considerations for manufacturers and regulators |
| ANSI/AAMI/UL 2800-1:2022 | Standard for Medical Device Interoperability |
| AAMI TIR105:2020 | Risk management guidance for combination products |
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