ANSI/AAMI/UL 2800-1:2022
Current
Current
The latest, up-to-date edition.
Standard for Medical Device Interoperability
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
20-05-2022
€275.00
Excluding VAT
This Standard is applicable to interoperable medical products, including assembled systems of interoperable medical products that comprise or are intended to be incorporated into interoperable medical systems within an interoperable environment.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-843-0
|
| Pages |
72
|
| ProductNote |
This standard also refers to AAMI/UL 2800-1-1, AAMI/UL 2800-1-2, AAMI/UL 2800-1-3,
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| IEC 60601-1-8:2006 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| AAMI TIR57:2016(R2019) | Principles for medical device security—Risk management |
| IEC 80001-1:2021 | Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software |
| ASTM F 2761 : 2009 : R2013 | Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model |
| IEC 60601-1:1988 | Medical electrical equipment - Part 1: General requirements for safety |
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