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In the last few years new
medical device standards have been developed for Risk Analysis.
EN1441 and EN60601-1-4 have been Harmonized under the Medical Device
Directive (MDD) and may apply if you are selling product in Europe.
EN ISO 14971 is in the process of being approved in Europe and it is intended
to be Harmonized under the MDD. These standards may also be used for meeting requirements in other
countries including the USA, Australia, the Far East and Canada: ·
EN1441 (1997) Medical devices –
Risk analysis ·
EN60601-1-4 (1996) Medical
electrical equipment Part1: General requirements for safety 4: Collateral
Standard: Programmable electrical medical systems · EN ISO 14971 Medical Devices - Application of risk management to medical devices The Risk Analysis should be
a living document throughout the design cycle and into production.
The steps of risk analysis are: 1.
Identify the potential hazards using cross functional teams that might
include engineering, R&D, clinicians, marketing, users, regulatory, product
safety engineers, manufacturing, etc. 2.
Define the probability and risk of each hazard using either a bottom-up
Failure Mode and Effect Analysis or a top-down Fault Tree Analysis. 3.
Determine which hazards have risk levels that require mitigation. 4.
Mitigate the hazards. Check
to ensure no new hazards are generated. Continue
to mitigate hazards until the risk level is low enough to be acceptable. EN1441 applies to all
medical devices from a tongue depressor to an implanted insulin pump, etc.
It covers risk analysis procedures, which includes identifying hazards
and estimating risks, associated with the device.
This standard does not stipulate levels of acceptability and isn’t
intended to give detailed guidance on risk management. EN60601-1-4 applies to
Medical electrical equipment (EN60601-1) and systems (EN60601-1-1) incorporating
one or more Central Processing Units (CPU’s) or computer processor chips.
The standard includes hardware, software, firmware,
and interfaces. The bad news
is if you have a medical piece of equipment that meets the definition of the
EN60601-1 or EN60601-1-1 and it has software, firmware, a CPU, etc. you may need
to go through the risk analysis for EN60601-1-4 as well as the risk analysis
under EN1441. The good news is that
EN60601-1-4 does follow some of EN1441 concepts so you won’t have to recreate
the wheel if you have done an EN1441 risk analysis. The Risk Analysis standards
are a good base for helping you establish a risk management system for your
medical devices. This will help you
meet the requirements of the MDD and may help for other National and
International regulatory requirements. If you have questions about risk analysis, technical files, CE Mark, or product safety issues please contact Leo@EisnerSafety.com |
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