In a previous article, we have reviewed the regulations for medical electrical equipment (MEE) in Mexico and mentioned the cases when a medical electrical equipment needs to meet local standards.
In this article we will review the applicability of a key series of international technical standards for medical electrical equipment, the IEC 60601.
International Standards Recognition in Mexico
Under normal circumstances, MEE must comply with Mexican standards to be sold in Mexico. But, as many MEE are imported from diverse countries, it is not unreasonable to think that not every manufacturer can perform a Mexican standard evaluation on their already tested products. Foreseeing this situation, the regulatory framework grants some flexibility in MEE testing, allowing tests performed under the reach of other international pharmacopoeias or widely renowned standards to be accepted.
IEC 60601 comprises a series of international technical standards that evaluate the safety and essential performance of MEE. It’s one of the most wide-known MEE standards, and viable for usage in justifying tests for MEE in Mexico. It includes diverse standards, grouped as:
- General standard: IEC 60601-1 includes all MEE for general basic requirements for safety and performance.
- Collateral standards: IEC 60601-1-X includes specific bearings of most MEE, such as IEC 60601-1-2 for electromagnetic compatibility.
- Particular standards: IEC 60601-2-X applies to distinctive groups of devices, for example IEC 60601-2-22 for surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60601 is not mandatory for most markets, including the USA and Europe. However, it is the most common way to demonstrate that requirements for safety and performance of MME are met. In Mexico, IEC 60601 testing is acceptable for sanitary registration of MME in addition to other sanitary requirements.
IEC 61010-1 & IEC 61326-1
Typically, the standards covered in the IEC 60601 can be used for the best part of the MEE. Still, in some cases, laboratory equipment can also be tested via the standards IEC 61010-1 & IEC 61326-1. These two standards, respectively, assure testing of safety requirements and EMC requirements. However, they are only suited for laboratory equipment and should only be considered as an alternative for such type of MEE.
Additional standards to meet according to MEE tariff code
A small portion of MME could be included in the tariff code that may require an additional standard according to the Agreement. Some medical devices or its components, such as displays that are included in tariff code 8528.49.01 indicate the need of compliance with NOM-019-SCFI-1998.
MEE in Mexico is subject to general sanitary regulatory requirements, general, collateral and/or particular IEC 60601 standards and also to specific local standards (NOMs). To get the sanitary registration of MEE’s in Mexico, it is important to define the characteristics and applicability of these standards.