SGS Fimko Ltd is a notified body for Personal Protective Equipment and Medical Devices. It means that we are competent to perform the conformity assessments of products covered by legislation.
The competent authority for PPE is Ministry of Social Affairs and Health, for MD Finnish Medicines Agency Fimea. We are also testing personal protective equipment and medical devices. Our testing laboratory is accredited by FINAS accreditation services.
Protective clothing and masks as the frontline against COVID-19 virus
Major protective devices against the COVID-19 virus are surgical masks, protective half-masks and eye protection.
Surgical masks
The purpose of surgical masks is to protect the patient from aerosols exhaled by the personnel during medical procedures. They are regulated according to the medical devices directive 93/42/EEC (or MDR (EU) 2017/745). The applicable harmonized standard is EN 14683:2019 Medical face masks - Requirements and test methods.
Surgical masks are class I devices. It means that a notified body does not assess the conformity of the devices and cannot issue an EC certificate for them. An exception to this are surgical masks that are supplied sterile. They are class I(s) and the sterilization process must be be assessed and certified by a notified body, for example SGS Fimko Ltd.
SGS CSTS Shanghai is accredited by China National Accrediation Services (CNAS) to perform testing according to standard EN 14683:2019.
Additional information and useful links for surgical masks:
- EU Commissions (through MDCG) excellent guidance for class I medical device manufacturers
- Chinese laboratories accredited by CNAS to perform testing of surgical masks
- European Accrediation’s Communication related to COVID-19, includes a listing of accredited testing laboratories performing related tests in Europe
Protective half-masks
Protective half-masks that are suitable to protect against COVID-19 virus have filtering capability of class FFP2 tai FFP3. They may be equipped with an exhalation valve. The half-mask must be fitted tightly on the face and it filters the inhaled air from particles and aerosols. They are regulated by PPER (EU) 2016/425 and the applicable harmonized standard is EN 149:2001+A1:2009 Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking.
Protective half masks are classified according to their filtering capability to classes FFP1, FFP2 or FFP3. The classes FFP2 and FFP3 are suitable to protect against COVID-19 virus.
In the PPE Regulation the protective half masks are risk class III protective devices, meaning that in addition to type testing and EC certification the manufacturer must have an agreement with a notified body for annual surveillance.
In many European countries, including Finland, national authorities have recognized that during the corona virus epidemic the half masks intended to be used by healthcare professionals may be placed on the marked with exceptional measures and the EC certification and CE marking are not required. It is adequate to have the half masks tested in an accredited laboratory. In addition to harmonized EN 149 standard also almost equivalent Chinese (GB2626) and American standards (NIOSH N95 / N99) may be applied.
SGS Fimko Ltd’s PPE testing laboratorio does not perform tests for protective half masks. Please see the European Accreditation’s Communication (above) or CNAS testing laboratory register for accredited testing laboratories.
Personal eye and face protective devices
Personal eye and face protective devices are regulated according to PPER (EU) 2016/425. There are multiple standards to be applied, depending on the intended use. The basic requirements are given in the harmonized standard EN 166:2001 Personal eye-protection - Specifications.
National authorities have derogated the requirements of face and eye protection visors when the devices are intended for professional use. The derogations are applicable only during the epidemic and the visors approved with derogated requirements may not be placed on the market and put into use after that. In Finland the minimum requirements are compliance to standard EN 166.
SGS Fimko Ltd does non-accredited testing according to the derogated requirements for protective visors. The visors are also in the scope of the SGS Fimko notified body.
SGS Fimko Ltd
Notified Body 0598
Designate to PPER (EU) 2016/425 and MDD 93/42/EEC
Please see the scope of notified bodies in the EU Nando database
Testing laboratory T004
Accredited according to standard EN ISO/IEC 17025.
Scope of the accreditation can be checked at FINAS web page
For more information, please contact:
Seppo Vahasalo
NB Manager, Medical Devices
Anna Ruhala
Product Line Manager, PPE Services