Medical protective materials - standards, quality testing and approval
In the context of COVID-19 pandemic prevention and containment
Version: October 30th, 2020
The novel respiratory disease COVID-19 (coronavirus 2019) is transmitted via small airborne droplets released by infected persons when sneezing, coughing or speaking. In the context of COVID-19 pandemic prevention and containment, various protective materials are used to prevent transmission and infection. These materials include medical devices such as medical face masks (medical mouth/nose masks, “surgical” masks), filtering half-masks (FFP1, FFP2 and FFP3 masks) and medical protective gloves. Respiratory protection masks made by the wearers themselves and worn in public places (so-called “community masks”) are not classified as medical devices (see information from the German Federal Institute for Drugs and Medical Devices (BfArM) (https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/schutzmasken.html).
For the use of medical devices, a special approval procedure is necessary. In some projects of PTB’s International Cooperation Department, partner institutions are responsible for these procedures, information on which is provided below.
Best practice examples during COVID-19
Special approval procedure of medical devices in Germany and in the EU
The COVID-19 pandemic is currently causing a considerable global supply bottleneck for the provision of appropriate protective medical masks. For this reason, the German Federal Institute for Drugs and Medical Devices (BfArM) has highlighted a special approval procedure in accordance with Section 11 (1) of the German Medical Devices Act (MPG) (https://www.bfarm.de/SharedDocs/Risikoinformationen/Medizinprodukte/DE/schutzmasken_sonderzualssung.html, https://www.bfarm.de/EN/MedicalDevices/_node.html ). If the use of individual medical devices is in the interest of public health protection, the German authority can, upon justified request, approve a temporary market authorization of these devices for which no procedures in accordance with the statutory order under Section 37 (1) have been carried out. This market authorization may be extended if a rationale for doing so is submitted in an application and approved. The EU Medical Devices Regulation (EU) 2017/745 allows a comparable procedure (Conformity assessment procedures for protective equipment: https://ec.europa.eu/docsroom/documents/40521 )
These special procedures for market authorization of medical protective masks under COVID-19 could serve as a guide for other countries to adapt their own legislation and procedures to the new conditions.
Free provision of standards and advisory services
The current standard on which the conformity assessment procedure for medical face masks is based is DIN EN 14683:2019-6 "Medical face masks - Requirements and test methods". The European standardization organizations CEN and CENELEC, with the agreement of all their members and in consultation with the European Commission, has made a number of European standards for medical devices and personal protective equipment available free of charge to help fight the COVID-19 pandemic. The aim of doing so is to address the growing shortage of protective masks, gloves and other protective materials that many European countries are currently facing. The free provision of standards is intended to support companies that want to change their production lines to manufacture these urgently needed protective materials at short notice. The standards are targeted at professional producers, not at private manufacturers of “community masks”. See DIN website: https://www.din.de/de/din-und-seine-partner/presse/mitteilungen/covid-19-din-stellt-normen-fuer-medizinische-ausruestung-zur-verfuegung-708596. See also the websites of ISO (https://www.iso.org/covid19 , EN) and the CEN members, e.g. DIN, AFNOR (EN and FR) AENOR and IPQ.
In order to clarify open questions related to the application, the standards organization DIN (Deutsches Institut für Normung) offers free advisory services. The dialogue platform DIN.ONE provides a platform for experts involved in the development of the standards to answer questions.
UN Women and UNECE have pointed out in a recent article that current standards often do not meet the different needs of all gender and therefore do not protect all workers equally. For example, protective goggles or gloves are not of the right size and shape for many women. Standards bodies are called upon to review the standards in order to become gender-responsive. See: UNECE, Gender-responsive Standards Declaration.
Example of current support in partner countries
In numerous bilateral and regional projects, the International Cooperation Department of PTB supports developing and emerging countries in the development and use of a demand-oriented and internationally recognized quality infrastructure. Its projects are implemented on behalf of the German Federal Ministry for Economic Cooperation and Development (BMZ). In connection with the Covid-19 pandemic, PTB addresses specific requests of the partner countries – including quality assurance for so-called “community masks”.
One example – Tunisia:
Our project partner, the Tunisian Ministry of Industry, requested support for:
- Expansion of testing capacities for quality assurance of “community masks” made of cotton in local mass production for the internal market
Based on this request, PTB supported the procurement of test equipment for community masks and provided technical advice and training. Here, the aim was to extend the competences of the national textile testing centre, CETTEX, and to further develop the testing and analysis capacities in the partner country.
Further potential support by PTB’s International Cooperation Department in its partner countries
In the context of the COVID-19 pandemic, PTB can support the development of test procedures in the testing laboratories of partner countries responsible for the approval of medical devices in accordance with EU Regulation 2017/745 or of personal protective equipment (PPE) in accordance with EN 149. Currently, no ISO standards are available, but European (EN), German (DIN), British and Chinese standards exist. In PTB's partner countries, the food and drug authorities, national standards bodies and local specialized technical centres (e.g. Centre Technique du Textile, CETTEX Tunisia) are usually responsible for conformity assessment of medical devices.
Provision of relevant standards and technical advice
In the short term, and depending on the project objective, cooperation scope and partner institutions, PTB’s International Cooperation Department could potentially procure required standards (e.g. product and testing standards for medical protective materials) which are not free of charge for its partner countries and, if necessary, translate them into the respective national language. In addition, an online technical advisory service could be carried out for the adaptation and adoption of the standards. In this case, a comparison of the EN, DIN or ISO standards with those of the WHO would be useful in order to adapt the standards in such a way that they are practicable and implementable for local use.
Based on partner requests, in the medium to long term, PTB could also examine the provision of support and expert advice on the development of appropriate guidelines to assure the quality of protective materials and other medical devices even beyond the scope of the COVID-19 pandemic. The implementation of certification procedures for medical devices is also a medium to long-term process which PTB could consider supporting.