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24 Safety Risk Management for Medical Devices

Figure 5.1 ISO 14971, a central standard.

order to combine efforts, JWG1 IEC/SC 62A was formed, so 14971 is the product of
work by both IEC and ISO. The ISO designation was chosen because 14971 is not
just about medical electrical equipment, but about all medical devices.
ISO 14971 was first released in the year 2000. The second edition was promulgated
in March 2007, and it canceled and replaced the 2000 version. ISO 14971:2007 [3] is
still current in the United States. European harmonized standard EN ISO 14971:2012
[7] identifies discrepancies between ISO 14971:2007 [3], and EU directives: 93/42/
EEC on Medical Devices [4], 90/385/EEC on AIMDs, and 98/79/EC on in Vitro
Diagnostics, and adds three annexes: ZA, ZB and ZC to ISO 14971:2007 [3].
Prior to ISO 14971 there was no other standard to address the risk management
of medical devices. ISO 14971 was drafted as a framework because there are so many
different types of medical devices, that it is difficult to produce a specific process that
would cover all devices. ISO 14971 is applicable to the complete product lifecycle,
from concept to decommissioning and disposal.

5.2 HARMONIZED STANDARDS

In a strict legal sense, regulatory entities do not “require” compliance with either ISO
14971:2007 [3], or EN ISO 14971:2012 [7]. Under EU legislation, the use of stan-
dards (or harmonized standards) is purely voluntary and you are free to comply with
the Essential Requirements of the Directives via other means. However, with regard
to risk management, ISO 14971 is the recognized reference standard, and compliance
to it makes it easier to persuade a notified body that your device is acceptably safe.