Abstract
Medical devices developed for human application are used for diagnostic or treatment purposes. Researchers in charge to develop new medical devices are faced with the complex task of making a medical device safe for human use. This implies that the device should be safe and effective. Risk management involves the identification, understanding, control and prevention of failures that can result in hazards when people use medical devices. The purpose of this chapter is to describe the importance of risk analysis and risk management process of medical devices.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Abbreviations
- CMR:
-
Carcinogenic, mutagenic and toxic for reproduction
- EDs:
-
Endocrine disruptors
- ISO:
-
International Organization for Standardization
- PBT:
-
Persistent bioaccumulative toxic
- vPvB:
-
Very persistent and very bioaccumulative
References
ISO 14971: 2019 Medical devices – Application of risk management to medical devices ANSI/AAMI/2019.
ISO/TR 24971:2013 Medical devices – Guidance on the application of ISO 14971.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2022 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this chapter
Cite this chapter
Sampath, T., Thamizharasan, S., Vijay Kumar Shetty, K., Timiri Shanmugam, P.S. (2022). ISO 14971 and ISO 24971: Medical Device Risk Management. In: Timiri Shanmugam, P.S., Thangaraju, P., Palani, N., Sampath, T. (eds) Medical Device Guidelines and Regulations Handbook. Springer, Cham. https://doi.org/10.1007/978-3-030-91855-2_3
Download citation
DOI: https://doi.org/10.1007/978-3-030-91855-2_3
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-91854-5
Online ISBN: 978-3-030-91855-2
eBook Packages: EngineeringEngineering (R0)