Class IIB: Device-Specific ISO Standards

1. Key takeaways

Acuerdo No. 0631-ARSA-2023, the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario, provides in Article 45 that the dossier for Class IIB devices consists of the items listed in Articles 43 and 44 plus one addition: the currently valid version of the ISO standard corresponding to the device. The provision lists by way of example ISO 13485, ISO 10993-1, ISO 14155 NTC, ISO 14155 and ISO 6872, and keeps the open-ended wording of or another ISO standard in line with the specific type of medical device (u otra norma ISO acorde al tipo específico de dispositivo médico). The GRZAN regulatory team notes: Article 45 is the only provision in the regulation that writes its documentation requirement in an examples-plus-open-ended manner — the Class IIB document list is therefore not fixed, and the ISO set must be argued item by item against the device type. A poorly argued selection will trigger a request for additional documents, and that supplement consumes the six-month window of the risk classification report.

2. Legal basis

The table below maps the requirements relevant to Class IIB to their provisions and key points.

3. Expert insights

Insight 1: the examples-plus-open-ended drafting of Article 45 cuts both ways. The benefit is that companies can select the ISO standard that best fits the device; the risk is that the selection must be argued. The GRZAN regulatory team recommends adding a page to the dossier titled ISO applicability statement, explaining item by item which device characteristics the selected standards address (material contact, implantation, clinical studies, dental materials, and so on), turning the open-ended requirement into a reviewable argument.

Insight 2: ISO 10993-1 corresponds to biological evaluation, ISO 14155 to clinical studies. By placing the two families side by side, the provision is effectively organising standards by evaluation dimension rather than by product category: 10993-1 addresses the biological reaction between materials and the human body, while 14155 addresses the conduct of clinical trials. Which one to choose depends on the evidence you use to demonstrate safety, not on the medical specialty the product belongs to.

Insight 3: ISO 6872 is the dental ceramics standard, showing the list reaches specialty materials. The inclusion of 6872 indicates that ARSA’s expected scope covers specialty devices such as dental restorative materials. For dental and orthopaedic material products, the note is that the device-specific ISO is often a better fit than the generic ISO, so specialty standards should be searched first.

Insight 4: the testing requirements of Class IIB and Class III differ; do not perform Class III tests prematurely. Article 45 requires only the corresponding ISO standards (the standard texts or conformity evidence), whereas Article 46, item 3, requires certified testing (biocompatibility, stability, cytotoxicity, electrical safety). The difference in cost and lead time is substantial — classify first, then decide whether testing is needed.

Insight 5: the ISO version requirement is current and valid. Article 44, item 2, and Article 45, item 2, both say en su versión vigente. Combined with Article 90’s statement that the regulation is revised with international progress, companies should verify before submission that the ISO certificate they hold reflects the current version; outdated certificates may be challenged for renewal during review.

4. Practical recommendations

• Add an ISO applicability statement page to the Class IIB dossier, arguing item by item how each selected standard corresponds to the device characteristics.
• Select standards by evaluation dimension: 10993-1 for material contact, 14155 for clinical studies, and dedicated standards searched for specialty materials.
• Classify first, then decide on testing: Class IIB submits standards, Class III submits certified testing.
• Before submission, verify that the ISO certificate version is the currently valid one.
• Discuss the selected ISO standards with ARSA at the classification stage to avoid supplements consuming the six-month window of the classification report.
• Record the selected ISO standards in the internal product file as the baseline for renewal and change comparisons.

5. Verification checklist

• □ An ISO applicability statement has been written for the Class IIB product
• □ The selected standards have been argued by evaluation dimension (biological, clinical, specialty materials)
• □ The testing scope has been fixed by class (IIB submits standards; III submits testing)
• □ The ISO certificate version has been confirmed as currently valid
• □ The selected ISO list has been discussed with ARSA at the classification stage
• □ The selected ISO list has been recorded in the internal product file

Related reading: [Article 22 — What Class IIA adds](/honduras-medical-device-registration/class-iia-iso-13485-and-software/) | [Article 24 — What Class III adds](/honduras-medical-device-registration/class-iii-additional-requirements/) | [Article 09 — The four risk classes I, IIA, IIB and III](/honduras-medical-device-registration/four-risk-classes-i-iia-iib-iii/)

Regulatory information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Honduran market. Our team manages Secretariat of Health (SESAL) registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com