UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements

M

Mark Meer

Trusted Information Resource
#1
#1
FDA 21 CFR 830.20 states the following requirements for UDIs:

A unique device identifier (UDI) must:
(a) Be issued under a system operated by FDA or an FDA-accredited issuing agency;
(b) Conform to each of the following international standards:
(1) ISO/IEC 15459-2, which is incorporated by reference at ?830.10;
(2) ISO/IEC 15459-4, which is incorporated by reference at ?830.10; and
(3) ISO/IEC 15459-6, which is incorporated by reference at ?830.10.
(c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at ?830.10.
Click to expand...
Question is regarding the ISO/IEC 15459 requirements.
I'm not familiar with these standards. Are there any surprises here?

...or if you're following the specifications of a particular FDA-accredited agency (e.g. GS1), is it reasonable to assume the requirements of these standards are met?
 
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Pads38

Trusted Information Resource
#3
#3
Also being unfamiliar to those standards, and to satisfy my own curiosity, I looked them up:
ISO/IEC 15459-1:2006
Information technology -- Unique identifiers -- Part 1: Unique identifiers for transport units

ISO/IEC 15459-2:2006
Information technology -- Unique identifiers -- Part 2: Registration procedures

ISO/IEC 15459-3:2006
Information technology -- Unique identifiers -- Part 3: Common rules for unique identifiers

ISO/IEC 15459-4:2008
Information technology -- Unique identifiers -- Part 4: Individual items

ISO/IEC 15459-5:2007
Information technology -- Unique identifiers -- Part 5: Unique identifier for returnable transport items (RTIs)

ISO/IEC 15459-6:2007
Information technology -- Unique identifiers -- Part 6: Unique identifier for product groupings

ISO/IEC 15459-8:2009
Information technology -- Unique identifiers -- Part 8: Grouping of transport units
Click to expand...
which doesn't yet answer your question!
 
M

Mark Meer

Trusted Information Resource
#4
#4
Yes, I looked them up too.

Oddly, the FDA CFR only mandates conformance to parts -2, -4 & -6.
...so for the purposes of this thread, I'm really just interested in these...

My gut tells me (or wants to...) that as long as one is following the specifications of an FDA-accredited issuing agency (GS1, HIBCC...), then the requirements of these standards are also met...

But it'd be nice if anyone familiar with ISO/IEC 15459 could confirm this...
 
M

Mark Meer

Trusted Information Resource
#5
#5
From the publication previews of these standards, "GS1 General Specifications" is always listed as a normative reference.

...this makes me a little more confident that any GS1-compliant system should meet these standards.

No mention of HIBCC though...
 
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