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practicable for a particular product. Points to consider as far as feasibility
include extent of research or development, length of time for regulatory
approval, effect of modifications, extent of supporting studies or testing,
supply chain availability, and other points associated with practicality of an
extensive delay or redesign.
The revision of AAMI ST67 that is in process will include several
changes and additions to the current version. One main change is that ST67
will more closely harmonize with ISO TS 19930 in language, format, and
inclusions. AAMI ST67 not only embraces the guidance in ISO TS 19930
but also provides, as a national standard, requirements that can be used to
support the choice of an alternative SAL.
As in ISO TS 19930, the ultimate goal in AAMI ST67 is to seek an
appropriate balance between the clinical benefit of a product and patient
safety and the scale of risk and feasibility of what might be required in re-
−6
sources versus logistics to sterilize to a maximal SAL of 10 , compared to
using an alternative SAL or selecting aseptic processing.
Regarding AAMI ST67, ISO 13408, and any future published standards,
the FDA maintains a searchable database of current “FDA-recognized con-
sensus standards” at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfStandards/search.cfm. This database enables the user to determine if a
standard is currently FDA-recognized, and if so, it provides the user with
a “Supplemental Information Sheet” (SIS). The SIS will enable the user to
identify the edition of the standard that is recognized based on publication
date, identify the individual subparts that are recognized (e.g., part 1, 2, or 3),
and provide additional valuable information in the “Extent of Recognition”
and “Relevant FDA Guidance and/or Supportive Publications” sections.

9.5.2 European standards for terminal sterilization
EN 556-1, Sterilization of medical devices—Requirements for medical de-
vices to be designated “STERILE”—Part 1: Requirements for terminally
sterilized medical devices was initially published in 1994 to provide require-
ments for designating devices as sterile that would be consistent across all
methods of terminal sterilization. EN 556-1 was updated in 2001 without
changing the core requirement, a corrigendum was issued in 2006 and
the standard was subsequently reconfirmed without change. EN 556-1 has
been harmonized under the Medical Devices Directive and is expected
to be harmonized under the Medical Devices Regulation. EN 556-1 has
been adopted by countries outside of the EU, including by Australia, China,
Israel, and South Africa.