The European Committee for Standardization - CEN and the European Committee for Electrotechnical Standardization - CENELEC have decided, after the request of the European Commission, to allow free access to a number of standards for medical devices and personal protective equipment to all stakeholders.

This decision was motivated by the need to tackle the severe shortage of protective masks and medical equipment experienced all around Europe, due to the exponential growth of the COVID-19 virus.

According to the CEN and CENELEC, the following standards are available for free download:

BAS EN 149 + A1:2010, Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as ‘FFP masks’)
BAS EN 14683:2019,  Medical face masks - Requirements and test methods
BASEN 166:2003, Personal eye-protection – Specifications
BAS EN 14126:2005, Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
BAS EN 14126 + Cor 1:2006 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
EN 14605 + A1:2010, Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only
EN 13795-1:2019, Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
EN 13795-2:2019, Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
BAS EN 455-1:2003, Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
BASEN 455-2:2016, Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
BASEN455-3:2016, Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
BASEN455-4:2011, EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
BAS EN ISO 374-5:2018, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks
BASEN ISO 13688:2014, Protective clothing - General requirements
BAS EN ISO 10993-1:2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
BASEN ISO 10993-1/Cor 1 2012, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

The Institute for Standardization of BiH acted in accordance with this decision of CEN and CENELEC, and we would like to invite all stakeholders, manufacturers in this field and those who will temporarily refocus their activities in the crisis period on the production of medical devices and protective equipment, to download the necessary standards.


If you have not purchased the standards before, first you must register through our website and then order the required standards. Standards are delivered only electronically. For more information about ordering a standard, you can contact us at: bas_prodaja@bas.gov.ba.