COVID-19

CONTEXT

KNOW THE CONTEXT

Following the whole COVID-19 global context, EQUILIBRIUM Laboratory has worked together with its clients at an international level, so that we can give a timely response to companies and to the population in general. Always with a view to impartiality in results and speed in services.
It is crucial to establish the purpose of your product in order to classify it.

After classifying, and before placing their products on the market, manufacturers and distributors must follow these guidelines:

Product
Textile

Device
Medical

EPI

Biocides

Product

Mask social use

-Clinical mask

-EN 14683:2019

-Surgical gowns, Leggings, Cuff caps, Gowns, Boot/shoe covers

- EN 13795-1:2019

- Respiratory protective device (EN149:2001+A1:2019) (with ratings FFP1, FFP2 e FFP3)

- Integral Suit/Coverall

- EN 14126:2003/AC:2004 e EN 14605:2005+A1:2009;

- Protective gloves

Biocides/ Disinfectants

authority
competent

Authority Supervisory ASAE

Competent authority INFARMED

Supervisory Authority ASAE

Authority competent INFARMED

Referential

CWA 17553:2020 (for European market) and DNP TS 4575:2020 (for national market)(yet is not mandatory certification of the product accredited)

Directive 93/42/CEE

Regulation
UE/2016/425

Informative Note
Specific changes and recommendations/guidelines by the state and supervisory bodies of each country are safeguarded.

Each area of performance is based on the Legal and Normative framework, being important the harmonization of characteristics and test methods at the level:

– Minimum performance requirements

– Specifications of the appropriate test methods

– Recommendations for use

In the specific case of community face covers, the document CWA 17553:2020, provides a support for producers. Specific changes and recommendations / guidelines by state and supervisory bodies of each country are safeguarded.

EU face covers are not subject to mandatory to mandatory conformity assessment by notified bodies or laboratories.

Their design according to accepted best practices and production quality control remains the responsibility of the producer. The producer may need to use a laboratory to verify the required performance. The community face cover specified in this document is neither a medical device (MD) under Directive 93/42/CEE or Regulation (EU) 2017/745 nor a personal protective equipment (PPE) under Regulation (EU) 2016/425. The producer may need to use a laboratory to verify the required performance. The community face cover specified in this document is not a medical device (MD) within the scope of Directive 93/42/CEE or Regulation (EU) 2017/745, nor is it a personal protective equipment (PPE) within the scope of Regulation (EU) 2016/425.

YOU CAN DIRECTLY CONSULT
THE DOCUMENTS HERE

CWA 17553:2020_Community face coverings - Guide to minimum requirements, methods of testing and use
website European Comission NANDO