Manufacturers of office/information technology equipment/audio/video, information and communication technology equipment (OFF/ITE/AV_ICT) used in healthcare facilities or integrated into end product medical electrical equipment (MEE) or medical electrical systems (MES) are in a unique and challenging position as they attempt to appropriately certify their products and components to meet end product requirements and regulatory needs.
Manufacturers of OFF/ITE/AV_ICT equipment organize their safety certification activities to meet market requirements, including regulatory requirements and requirements from end product MEE/MES manufacturers.
- OFF/ITE/AV_ICT equipment needing certification are typically finished products that form part of the medical electrical equipment (the total assembly of components/products that meets regulatory requirements for placement into the market to perform a diagnosis, treatment, or monitoring of a patient or compensation or alleviation of a disability, injury or disease). The scope of the primary certifications standards – IEC, EN, CSA or AAMI 60601-1 (editions and amendments since 2005) only covers complete, fully configured MEE or MES. Therefore OFF/ITE/AV_ICT do not fall into the scope of the base standard of IEC, EN, CSA or AAMI 60601-1.
- Electrical equipment manufacturers of OFF/ITE/AV_ICT (e.g., display devices, printers, PCs, tablets falling under the scope of IEC/UL 62368-1, the Standard for Audio/video, information and communication technology equipment - Part 1: Safety requirements) will find their equipment utilized in an end product MEE or MES.
From these key challenges, this paper will clarify the regulatory (and therefore market access) requirements and certification outputs (test reports/certification marks and certificates) for manufacturers of OFF/ITE/AV_ICT equipment that do not fall within the scope of IEC, EN, CSA or AAMI 60601-1 standards.
Note: The scope of this document is only for CB Scheme and NRTL (UL and C-UL Marks) projects. UL Solutions can evaluate ITAV equipment to IEC 60601-1 and related standards (IEC 60601-1-2, IEC 60601-1-6 or other collaterals) and issue a full informative test report. The scope of this evaluation can be as broad or as narrow as requested by the manufacturer of the ITAV equipment.
The IECEE CB Scheme has established operational rules, documents and decisions which govern the scheme and which must be followed. Recently, IECEE CTL issued Preliminary Decision Sheet PDSH-2208 related to this topic. PDSH-2208 can be found here.
The paper will focus on a transition timeline and continued viable certification and reporting options for manufacturers of ITAV equipment.
It is important to note that there are differences between the terms “medical device” and “medical electrical equipment and systems” (MEE/MES). The term “medical device” is a regulatory term for a very broad set of products that fall under regional regulations for import and use. “Medical electrical equipment and systems” is a term from the IEC 60601-1 series of standards related only to active electrical medical equipment and systems. Regulators may treat OFF/ITE/AV_ICT equipment as a medical device, even if the equipment does not align with the scope of the IEC 60601-1 series of standards.
Transition timeline
To give some transitional time from the publication of this CTL decision, UL Solutions has carefully considered the needs of the industry, the IECEE requirements and the future needs of manufacturers of OF/ITE/AV_ICT equipment intending integration into other MES.
UL Solutions will continue to fulfill (UL/cUL Mark + CB Scheme) all open orders, including orders opened up to Oct. 31, 2023.
UL Solutions will continue to issue certification (UL/cUL Mark + CB Scheme) up to June 30, 2024.
Following these time periods, there are additional certification options and report outputs that will continue to serve the industry into the future.
Product certification options and offerings for OFF/ITE/AV_ICT manufacturers to support meeting MEE and MES regulatory requirements
Options exist for OFF/ITE/AV_ICT manufacturers wanting coverage in the medical environment (integrated into MEE, part of an MES or used in a healthcare facility), including:
- Complete dual certification as ITAV/MED
- NRTL mark – This requires an intended use that aligns with scope and defined terms in CSA and AAMI 60601-1.
- CB Scheme – To comply with IECEE PDSH-2208, OFF/ITE/AV_ICT cannot be evaluated to IEC 60601-1.
- Listed OFF/ITE/AV_ICT (UL, CSA 62368-1) and Recognized medical (AAMI, CSA 60601-1)
- Recognized medical only (AAMI, CSA 60601-1)
- Supplemental evaluation options – OFF/ITE/AV_ICT equipment may be additionally evaluated to all or parts of medical standards to supplement the IECEE TRF and certificate issued under the ITAV or OFF categories. The standards used for supplemental evaluation can be included in Page 2 of the ITAV or OFF CB certificate.
- Informative test report
Certification options for OFF/ITE/AV_ICT equipment used in MEE or MES
Based on the above analysis of the certification and regulatory requirements for ITAV equipment used as part of MEE or MES, there are relevant certification options that ITAV manufacturers should be aware of.
The following table illustrates the options that cover the certification pathways for IECEE NCBs, NRTLs and the relevant service delivery options available.
| Outputs | ||||
|---|---|---|---|---|
| Service Description | CB Scheme | NRTL Mark (Listing / Classification) | NRTL Mark (Recognition) | Informative Report ** |
|
Partial Dual Certification Product “Intended Use” is typical for ITAV equipment |
Yes – 62368-1 only | Yes – 62368-1 | Yes – 60601-1 | Yes – 60601-1 OR 62368-1 |
|
UL Recognition Product “Intended Use” is typical for ITAV equipment |
N/A | N/A | Yes – 60601-1 * | Yes – 60601-1 OR 62368-1 |
|
Informative Evaluation Product “Intended Use” is typical for ITAV equipment |
N/A | N/A | N/A | Yes – 60601-1 OR 62368-1 |
* Integration to MEE/MES may require additional evaluation to relevant safety standards for ITAV equipment, such as IEC 62368-1.
** The scope of informative test reports issued by UL Solutions can be broad or narrow. UL Solutions can evaluate to the entire standard, or just portions of the standard that may be important to ITAV manufacturers producing equipment for integration into MEE/MES (e.g., leakage current, ground bonding, isolation/spacings/dielectric testing).
For an informative report output, the documentation received by the manufacturer is in the same format as a CB Scheme report (Full TRF); however, based on the scope of the work, there may be clauses or sections not evaluated.
Conclusion
With these market access, and end-product manufacturer concerns, UL Solutions has established a transitional period and service offerings to suit the marketplace demands. Our sales staff and technical experts are familiar with this topic and available to work through technical questions and certification options presented here.
Get connected with our sales team
Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.