Source: https://www.iss.rs/en/news/news_182.html
Timestamp: 2020-04-08 22:45:01
Document Index: 475485505

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 4', 'art 1', 'art 5', 'art 5']

Free download of standards for protective equipment and medical devices
To reply to this extraordinary challenge in the battle against the COVID-19 pandemic globally, the CEN and CENELEC Presidential Committee decided to allow free-of-charge access to a number of standards in the field of production of personal protective equipment and medical devices, as well as patients and public. This decision was made in order to permit, due to the increasing need for additional quantities of personal preotective equipment and medical devices, the manufacturing facilities of companies engaged in other activities to be temporarily re-direct to such production and to comply with European standards.
According to the statement from CEN and CENELEC, all CEN and CENELEC members national standards bodies are required to allow all interested parties to download national adoptions of the following European standards in the field of personal protective equipment and medical devices, free-of-charge, i.e.:
EN 149:2009, Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
EN 166:2001, Personal eye-protection – Specifications
EN 14126:2003+AC:2004, Protective clothing - Performance requirements and tests methods for protective clothing against infective agents
EN 14605:2005 +A1:2009, 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 (Types PB [3] and PB [4])
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
EN 455-1:2000, Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD)
EN 455-2:2015, Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD)
EN 455-3:2015, Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD)
EN 455-4:2009, Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD)
EN 14683:2019, Medical face masks - Requirements and test methods
EN ISO 10993-1:2009+ AC:2010, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993- 1:2009)
EN ISO 374-5:2016, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
EN ISO 13688:2013, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)
In accordance with this CEN and CENELEC decision, the Institute for Standardization of Serbia (ISS) provided free access to the national adoptions of the above mentioned standards and invites all interested parties, manufacturers in this field or those who will temporarily re-focus their activities during the crisis period on the production of safety gloves, clothes, masks and other protective equipment and medical supplies to download these standards.
In order to download these standards, you either need to sign in, in case you are a new user, or to place an order using your already existing account and your username and password, and our sales team will deliver or forward the required standards to you in the way you chose.
As we have previously informed our users, during the state of emergency, in order to prevent the COVID-19 outbreak spreading, the work with the customers at ISS premises is suspended. To obtain all necessary information regarding theses and other standards and ISS services, you can contact us by telephone at the following address: https://www.iss.rs/en/news/news_183.html