COVID-19 Frequently Asked Questions (FAQs) 

ABOUT US AND OUR RESPONSES TO COVID-19

The following questions will answer more general information about European Standardization, the roles of CEN and CENELEC, and the specific actions that were taken to help combat COVID-19.

Who are we and what do we do?

In Europe, standards are developed and agreed upon by the three officially recognized European Standardization Organizations (EU Regulation 1025/2012): the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) and the European Telecommunications Standards Institute (ETSI). CEN and CENELEC bring together the National Standards Bodies (CEN) and National Committees (CENELEC) of 34 countries, including business federations, commercial and consumer organizations, environmental groups and other societal stakeholders.
 
A European Standard (EN) carries with it the obligation to be implemented at national level by being given the status of a national standard and by withdrawal of any conflicting national standard. Therefore, a European Standard automatically becomes a national standard in all 34 CEN and CENELEC member countries.
 
More than 60 000 technical experts are directly involved in our work. By setting common standards that are applied identically in 34 countries, CEN and CENELEC ensure the protection of consumers, facilitate cross-border trade, allow the interoperability of products, encourage innovation and technological development, consider and provide environmental protection, as well as enable businesses to grow.
 
Together, CEN and CENELEC provide a platform for the development of European Standards and other technical specifications across a wide range of sectors. We work closely with the European Commission and EFTA to ensure that standards correspond with any relevant European and EU legislation.
 
CEN and CENELEC cooperate with both the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) to reach agreements on common standards that can be applied throughout the whole world following the "international first" principle.

Our first actions in the fight against COVID-19?

In response to the coronavirus outbreak, CEN and CENELEC agreed, in collaboration with all their Members and after an urgent request from the European Commission, to make freely available a series of European standards for medical devices and personal protective equipment (PPE) used in the context of the COVID-19 pandemic.
 
In addition, the CEN-CENELEC COVID-19 Crisis Management Network was established, bringing together national representatives from each CEN and CENELEC Member to facilitate a direct exchange of information between Members and, where necessary, fast track responses by CEN and CENELEC at the European level.

Which standards are made freely available?

This link provides the list of standards that were made available by CEN and CENELEC on 20 March 2020.

The exceptional decision to make these standards available for free was, and still is, motivated by the need to tackle the severe lack of availability of masks, personal and medical protective equipment that has been experienced all around Europe during the exponential outbreak of the COVID-19 pandemic.

These standards were selected by CEN and CENELEC, in response to an urgent request by the European Commission looking to enable alternative production lines and increase the overall capacity to produce PPE and Medical Devices in Europe.

For more information on the response of CEN and CENELEC during the COVID-19 pandemic, please visit our website.

For information about the standards made freely available at the international level, click here for the standards made available by ISO and here for the list of standards made available by IEC.

How are European standards related to regulation?

European standards are voluntary which means that there is no automatic legal obligation to apply them. However, laws and regulations may refer to standards and even make compliance with them compulsory.

Standards can be a tool to support the implementation of a regulation. As such, they are not regulation. This separation is what allows standards to keep up with continuous technological development and innovation.

Standards developed in response to a standardization request from the European Commission are called ‘harmonized standards’. They are developed to support the implementation of EU legislation, which means that products manufactured in compliance with a harmonized standard enjoy a ‘presumption of conformity’, allowing them to be sold throughout the EU European Single Market. Once referenced in the Official Journal of the European Union, the standard gains legal effect, while remaining entirely voluntary in nature. An estimated 20% of all European standards are harmonized standards.

Are European COVID-19 standards applied in countries outside Europe?

To date there are 34 European COVID-19 related standards that have been, or are going to be, adopted in 14 countries outside Europe. These standards include, but are not limited to those currently provided for free (see link provided under Q1.3). For a regularly updated overview of which countries adopted which European standards to support their fight against COVID-19, please see here.

The most popular standards are the following (in order of the number of countries who adopted them):
 
1) adopted by 11 countries –
  • EN 14683:2019 “Medical face masks - Requirements and test methods”
2) adopted by 5 countries –
  • EN 149:2001+A1:2009 “Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking”
  • EN 1499:2013 “Chemical disinfectants and antiseptics. Hygienic handwash. Test method and requirements (phase 2/step 2)”
  • EN 1500:2013 “Chemical disinfectants and antiseptics - hygienic hand rub- test method and requirements (phase 2/step 2)”
 

OBJECTIVES AND BENEFITS OF MAKING MEDICAL AND PERSONAL EQUIPMENT STANDARDS AVAILABLE DURING THE CRISIS

The following questions will address the motivation behind the availability of the standards that were provided and how businesses are able to use these standards to increase the production of Personal Protective Equipment and medical devices.

Why do we provide these standards free of charge now and who are we primarily addressing with this offer?

The purpose of making this set of European standards freely available is to help those companies volunteering to alter their production lines to produce urgently needed medical equipment in the short term. The standards are aimed purely at professional users.

What are the benefits for companies?

The use of standards can help to ensure the safety of Medical Devices and PPE, and can provide practical assistance to manufacturers during production.

Why are the standards referenced in the respective standards not free of charge as well?

Most of the referenced standards are testing standards which require a certain amount of testing equipment and accreditation as a testing laboratory, which in most cases is not applicable for market operators.

Why are such standards not always free?

Standards codify the knowledge of hundreds of independent experts. Users benefit from several advantages, including increased efficiency, cost savings, easier market access and a reduction in product liability risk. By purchasing standards, users ensure that the work of CEN and CENELEC and their national members as non-profit organizations, remains independent, industry-led and consensus driven.

Will standards remain free after the pandemic?

The purpose of making this set of COVID-19 related standards available free of charge is to provide immediate support and help companies who are willing to convert their production lines, to produce urgently needed equipment at short notice. In principle, standards are and will remain chargeable products.

PLACING PRODUCTS ON THE MARKET TO FIGHT COVID-19

Both the PPE Regulation and the Directive on Medical Devices determine essential requirements on health, safety and performance of the products covered. However, both EU legal frameworks are technologically neutral and do not prescribe any specific mandatory technical solutions for the design of the products. Therefore, several technical solutions may be used by manufacturers to meet these essential requirements.
 
Both the PPE Regulation and the Directive on Medical Devices offer the possibility for manufacturers to rely on specific technical solutions, which are detailed in harmonised standards. The references of these harmonised standards have been published in the Official Journal of the European Union. Where a manufacturer chooses to adopt such a technical solution, the product is presumed to be in conformity with the applicable essential health, safety and performance requirements. (see Conformity assessment procedures for protective equipment, 30/03/2020)

What to consider when placing medical devices or personal protective equipment on the European market, either by manufacturing these products or by importing them?

If you intend to put Medical Devices or Personal Protective Equipment on the market, there are several steps you need to follow:
  1. Identify whether the product is classified as Personal Protective Equipment (PPE) or Medical Device (MD) or both as this determines the exact applicable legal requirements;
  2. Identify the relevant standards (technical solution), which may be applied on a voluntary basis and which guarantee a presumption of conformity with the applicable Regulation or Directive;
  3. Find out the applicable conformity assessment procedure for the product based on the category (PPE) or classification (MD) of the product;
  4. Identify a notified body that is designated for your product type and contact them to discuss the conformity assessment pathway, if applicable;
  5. Check the need to register your product with a National Competent Authority

What is PPE?

Personal protective equipment is any equipment designed and manufactured to be worn or held by an individual for the protection against one or more health and safety hazards. Interchangeable components and connection systems for such equipment are also considered as personal protective equipment. For the complete definition of the concept of ‘PPE’, please refer to Article 3(1) of the PPE Regulation.
 
Examples of PPE that may be used in the current COVID-19 response include: 
 
  • Facemasks (both disposable and reusable)
  • Gloves
  • Protective eyewear
  • Protective garments (e.g. coveralls, aprons etc.)

What EU legal framework applies to PPE?

Regulation (EU) 2016/425 (‘the PPE Regulation’) became fully applicable on 21 April 2018, when it repealed and replaced Directive 89/686/EEC.
 
For further information, please consult the dedicated European Commission webpage.
 

What standards should be applied for PPE?

Harmonized standards give presumption of conformity to certain essential requirements laid down by the PPE Regulation, the Medical Device Directive and the general safety and performance requirements of the Medical Device’s Regulation. In response to the COVID-19 Crisis, CEN and CENELEC have made a set of relevant European standards available through their national members. To access these standards, click here.
 
A link to the full list of harmonized standards for PPE currently provided for free can be found here.

Who can conduct the conformity assessment procedures for Personal Protective Equipment?

It is important to first identify the categorization of the product as it determines the conformity assessment procedures required.
 
Click here to be redirected to the EU NANDO website for a list of notified bodies designated under the PPE Regulation.
 
For a list of notified bodies designated to certify the products below, click the link:

What is a Medical Device?

A Medical Device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used alone, or in combination, by human beings, for one or more of the following medical purposes:
 
  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
  • Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
  • Providing information by means of in vivo examination of specimens derived from the human body including organ, blood and tissue donations
And which does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on the human body, but which may be assisted in its function by such means.
 
Examples of Medical Device that may be used in the current COVID-19 response:
 
  • Surgical masks
  • Medical gloves
  • Surgical drapes and gowns
  • Ventilators
  • Nebulisers

What EU legal framework applies to Medical Devices?

The Council Directive 93/42/EEC on medical devices and the active implantable medical devices (Directive 90/385/EEC) have both been replaced by Regulation (EU) 2017/745.
 
However, the date of applicability of  Regulation (EU) 2017/745 has been extended by Regulation (EU) 2020/561 (MDR) to 26 May 2021.
 
Specific information on medical devices currently affected by COVID-19, can be found by searching active implantable medical devices (Directive 90/385/EEC) and in vitro diagnostic medical devices (Directive 98/79/EC and Regulation (EU) 2017/746).
 
For more information see the designate European Commission website.
 

What standards should be applied for Medical Devices?

Harmonized standards give presumption of conformity to certain essential requirements within the PPE Regulation, the Medical Device Directive and the general safety and performance requirements of the Medical Device’s regulation. In response to the COVID-19 Crisis, CEN and CENELEC have made relevant European standards available through their national members. To access these standards, click here.
 
A link to the full list of harmonized standards for Medical Devices can be found here, some of which are provided free in the previous link.

Who can certify Medical Devices?

It is important to first identify the classification of the product as it determines the conformity assessment procedures required.
 
Click here to be redirected to the EU NANDO website for a list of notified bodies designated under the MDD 93/42/EEC and here for a list of notified bodies designated under Regulation (EU) 2017/745 (MDR).
 

What are the measures taken about disinfectants?

Disinfectants are considered biocides in Europe and are regulated by the Biocidal Products Regulation (EU) No. 528/2012. Click here for a list of FAQs provided by the European Chemicals Agency (ECHA) for companies to place disinfectants on the European market in the context COVID-19. ECHA has more information on its COVID-19 measures on its website.
 

ALTERNATIVES TO THE USE OF EUROPEAN STANDARDS

Due to the scale of the pandemic, there is a global shortage of medical and PPE supplies. All governments are putting forward great efforts to ensure that health professionals and the public are protected by sufficient supplies, looking at a range of possible solutions, from encouraging domestic manufacturing of such supplies to increasing imports of products produced according to the equivalent or near equivalent standards in 3rd countries. As China is the world’s biggest supplier of many of these products (and is now recovering its production), Chinese standards are also being looked at by European governments.
 

a) World Health Organization (WHO) Guidelines

The World Health Organization (WHO) has developed guidelines for choice of personal protective equipment, providing a list of recommended technical solutions, covering mainly international standards, European standards and American standards.
 

b) Other Technical Solutions

How do Chinese COVID-19 standards compare with European ones?

The Standardization Administration of China (SAC), China’s national standards body and a member of ISO and IEC, has made its COVID-19 related standards available in English. Click here to download.
 
A comparative analysis between European and Chinese COVID-19 standards has been carried out by Chinese and European experts based on work initiated in China. The analysis compares standards for masks, gloves, medical protective clothing, personal protective equipment and eye protector. Click here for the details of an initial technical comparative analysis performed by the relevant CEN and CENELEC Technical Committees.

Disclaimer: The Following Q&As on mask standards are extracted from a media interview with the China Chamber of Commerce for Import & Export of Medicines & Health Products.

Are Chinese KN95 masks equivalent to US Surgical N95?

The KN95 masks under the Chinese standard GB 2626-2006 “Respiratory protection - Non-powered air-purifying particle respirator” can filter 95% of particles, just like US Surgical N95 masks, but it is usually intended for the general public. It is not fluid resistant. It is usually used for general protection against dust and small particles under a relatively low price. Thus, the assessment on whether N95 masks can be used for medical personnel in medical institutions, especially in heavily polluted areas such as ICU, what we call hospital red zones, shall be performed by Notified bodies and national market surveillance authorities.
 
US Surgical N95 masks, use a special coating technology to keep them fluid resistant and block droplets. It is relatively expensive. In principle, it is used in the fever clinic, quarantine observation ward, quarantine ward and quarantine ICU of the hospital, as well as during the operations that may generate aerosol. It is relatively small in quantity.
 
In fact, the Chinese masks equivalent to US N95 medical masks are Chinese medical protective masks defined by GB 19083-2010 “Technical requirements for protective face mask for medical use”, instead of KN95 masks. KN95 is for daily use, while medical protective masks are for medical purposes. Therefore, we would like to remind importers that they should use the masks properly, in strict accordance with the requirements set out in contracts.

What are the differences between Chinese KN95 masks and European FFP2 masks? What occasions are KN95 masks suitable for?

Chinese KN95 masks are tested for protection against saline particles, not against oily particles, and only KP95 masks are tested for protection against oily particles. Therefore, Notified Bodies and national market surveillance authorities might find that the masks that have passed KN95 tests may fail to pass the FFP2 test for protection against paraffin oil aerosol. Here, N stands for "Non-oil" (non-resistant to oily particulates), and P for "Oil protective" (resistant to oily particulates).
 
KN95 masks are suitable for protection against solid and non-oily particulates, liquid and microorganisms, such as coal dust, cement dust, acid fog, paint fog, etc. However, they provide limited protection against oil smoke, oil mist, asphalt smoke, coke oven smoke, particulates in diesel exhaust, etc.

What are the differences between Chinese mask standards and the European and US mask standards?

According to regulations, exported non-medical masks must conform to Chinese product standards such as GB2626-2006 and GB/T32610-2016, or meet the quality standard requirements of the importing country or region, such as the EU Regulation 2016/425, which is known as the Personal Protective Equipment Regulation (PPE Regulation).
 
The product classification and corresponding indicator requirements in China and foreign countries cannot be equated to one another. For example, different non-medical masks have different breathing resistance. GB2626 classifies products into three levels according to the leakage rate and filtering efficiency of the mask, and products at each level are classified as saline particulate-resistant and oily particulate-resistant; and EN 149 only classifies products into three levels of FFP1, FFP2 and FFP3.
 
For the standards of masks for daily use, China has GB 2626-2006 "Respiratory Protective Equipment—Non-Powered Air-Purifying Particulate Respirator" and GB/T 32610-2016 "Technical Specifications of Daily Protective Masks". They are both for masks for daily use, vastly different from GB 19083-2003 "Technical Requirements for Medical Protective Face Masks". The European Union's testing standard for masks for daily use is EN 149:2001+A1:2009 "Respiratory Protective Devices - Filtering Half Masks to Protect against Particles - Requirements, Testing, Marking", and its standard for medical face masks is EN 14683-2019. The US applies relevant NIOSH standards. Therefore, there are lots of differences in different countries’ testing standards in terms of the classification of product levels and specific testing indicators. We cannot simply equate one testing standard with another.
 
The supply of medical protective products is a highly regulated sector and each country has its own standards and inspection requirements. Chinese standards for medical protective products are relatively higher than many other countries. China forms its own regulatory system covering the approval, standard management, inspection and certification of products, which is not completely the same with foreign ones.
 
The information above has been collected from various sources. We are particularly grateful for the information provided by the European Commission, the National Standards Authority of Ireland (NSAI), the German Institute of Standardization (DIN), the Netherlands Standardization Institute (NEN) and the China Chamber of Commerce for Import & Export of Medicines & Health Products.