ISO TC 210 WG2 met in Tokyo, Japan 
on 4 – 5 March 2025.
WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed.
- Thx to the hard work of our fearless Project Leader, doing a huge amount of prep work just prior to the WG meeting.
- WG was able to review and resolve all the comments.
- Next step will be to circulate for FDIS ballot ISO/FDIS 20417, 2nd ed., that the NCs will vote on.
Changes proposed:
Add reference to transport and storage symbols for environmental conditions for packaging to distinguish between transport and storage environmental conditions.
- Updated sub-cl 6.5.3 a) new sub items 2) & 3) with symbols for transport and storage – Special Section
not included in LinkedIn Post - These symbols for transport is Symbol 3869 from ISO 14617-14:2004 (link goes to the ISO online browsing platform) and for storage is Symbol 2066 from ISO 14617-7:2002
- This has been something I have been developing for more than a year with TC 210/ WG3 and also IEC 60601-1, 4th ed., IEC TC 62/SC 62A/WG38 with a small team. At the Tokyo meeting TC210 / WG3 we have set up a task team to look at the proposed symbols for transport, storage and operation (operation was not included in ISO 20417 as no comment was provided). WG3 task team has not met yet so unable to share the proposed symbols from WG3 perspective at this time.
IEC TC 62/SC 62A/WG38, Fragment 2, (IEC 60601-1, 4th ed. – learn more about it) 62A/1630/CD was issued Dec 6 2024 and was closed for comments on Feb 28 2025. We are meeting in Arlington, Virginia at the AAMI offices to work on the comments March 30 – April 4, 2025. The two symbols above are part of the symbols that are in the CD and there are additional ones including one for operating IEC 60417‑6090:2012 and transient IEC 60417-5184:2002 environmental conditions, and indoor use IEC 60417-5957:2004. Some combination of the environmental conditions such as temperature, humdity, and atmospheric pressure will need to be combined as applicable to operation, storage and transport. Trainsient is a special condition. Please refer to the CD to understand the usage of the symbols.
Deleted 6.1.2 d) 1) (Change from “EC Rep” to “XX Rep”)
- Align with update of ISO 15223-1:2021/A1:2025 published March 3, 2025 with “EC Rep” changed to “XX Rep” (5.1.2).
- 6.1.2 d) 1) previously stated: “When using symbol 5.1.2 from ISO 15223-1:—, the ‘EC’ may be replaced by the 2-letter or 3-letter country code given in ISO 3166-1.”
Added concept of “applicable policy”
- New 3.3 definition.
- Aligns with 1/2634/CDV of IEC 60050-880, 1st ed, term 880-17-02) & about 20 additions in the normative text to “applicable policy” making those requirements based on what the authority having jurisdiction requires so more flexible.
Changed from “production control” to “production control identifier”
- Make clearer the definitions of lot number, lot code, batch code, batch number, serial number, & other options noted in 5.9 of ISO 20417, 1st ed. (will be 5.8 ISO 20417, 2nd ed.)
The requirements related to commercial product name were deleted as they were duplicative of the catalogue number requirements.
Deleted 4 b)
- The previous 4 b) roughly says: Normatively referenced edition of a standard in ISO 20417, ed., the manufacturer may substitute with a more current version provided by the manufacturer provided they can demonstrate the residual risk remains acceptable and is comparable to the residual risk that results from applying the normatively referenced document.
- The normative referenced standards in the new draft FDIS are undated or dated. Undated references are required to be the most recent copy of the standard and the dated ones are required to be the dated version. ISO 15223-1 is the only dated normative referenced standard and references ISO 15223-1:2021 and ISO 15223-1:2021/AMD 1:2025 (ISO format requirements) in the draft FDIS.
HAS Consultant comments received late, added to collated comments, and resolved. JTC3 will prepare updated Annex Zs for addition to the FDIS
updated the normative references
- Informative referenced standards (“should ” or “see standards” statement) were moved to the bibliography
- Dropped ISO 16142-1 & -2 standards as both were withdrawn
Delete former informative Annexes D, F, G and H;
- Annex D – Cross reference between the document and the requirements considered
- Annex F – Reference to the essential principles (ISO 16142-1:2016 & ISO 16142-2:2017 – both withdrawn)
- Annex G – Reference to the general safety and performance requirements for medical devices (Was previous corresponding list of GSPRs to the EU MDR list but will be replaced by Annex ZA#)
- Annex H – Reference to the general safety and performance requirements for IVD medical devices (Was previous corresponding list of GSPRs to the EU IVDR list but will be replaced by Annex ZB#)
- # Annex ZA & ZB The FDIS will include Annex ZA & ZB prepared by JTC3 but not the final ISO publication.
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