AAMI TIR105:2020
Current
The latest, up-to-date edition.
Risk management guidance for combination products
Hardcopy , PDF
English
28-09-2020
This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent part (drug−device, biological drug−device, or drug−device−biologic), in accordance with FDA’s final rule (21 CFR Part 4) [11]. 4
| DocumentType |
Guide
|
| ISBN |
978-1-57020-770-9
|
| Pages |
41
|
| ProductNote |
THIS STANDARD ALSO REFERS TO IEC 62366-2:2016,ISO/CD TR 20416
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| ISO 20072:2009 | Aerosol drug delivery device design verification — Requirements and test methods |
| ISO 14971:2019 | Medical devices — Application of risk management to medical devices |
| ISO 21649:2006 | Needle-free injectors for medical use — Requirements and test methods |
| IEC 60812:2018 | Failure modes and effects analysis (FMEA and FMECA) |
| AAMI TIR57:2016(R2019) | Principles for medical device security—Risk management |
| IEC 62304:2006 | Medical device software - Software life cycle processes |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| AAMI TIR48 : 2015 | QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| AAMI TIR59:2017 | INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability engineering to medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 12417-1:2015 | Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| AAMI TIR50:2014(R2017) | Post-market surveillance of use error management |
| ISO 20069:2019 | Guidance for assessment and evaluation of changes to drug delivery systems |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO 14971 |
| IEC 31010:2019 | Risk management - Risk assessment techniques |
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