ANSI/AAMI/UL 2800-1 : 2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard for Safety for Medical Device Interoperability.
Hardcopy , PDF
English
21-02-2019
18-01-2023
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 |
978-1-57020-711-2
|
| Pages |
180
|
| ProductNote |
THIS STANDARD ALSO REFERS:ISO/IEE Guide 51
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| AAMI TIR57 : 2016 | PRINCIPLES FOR MEDICAL DEVICE SECURITY - RISK MANAGEMENT |
| IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| ISO/IEC/IEEE 42010:2011 | Systems and software engineering — Architecture description |
| 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 |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 26262-1:2018 | Road vehicles — Functional safety — Part 1: Vocabulary |
| ISO/IEC 15026-3:2015 | Systems and software engineering — Systems and software assurance — Part 3: System integrity levels |
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