Coronavirus REsponse

Status on 13 January 2021, 8 a.m.

The corona pandemic raises enormous challenges for our society. To prevent an exponential spread of the COVID-19 virus again, we all are called upon to comply with a series of hygiene measures.

Because of the measures currently in effect, our office will be closed to external visitors until further notice!

We are available to you by phone or e-mail:

Monday to Thursday from 08.00 a.m. to 4.30 p.m. and
Friday from 08.00 a.m. to 2.30 p.m.

You can contact us as follows:

Telephone: +43 1 213 00 0
Email: [email protected]

 

Our Customer Area is open for browsing standards during the following hours:

Monday to Thursday from 08.00 a.m. to 3.00 p.m. and
Friday from 08.00 a.m. to 1.00 p.m.

The sale of books and specialized publications is unfortunately not possible at present.

 

The staff of Austrian Standards has switched to teleworking and works from home. In all divisions, you can contact us as usual based on our normal business contact data or via our switchboard.

All trainings, courses and certification activities will be performed digitally until further notice. We are pleased to keep you informed of forthcoming changes on our website. Tours of our interactive exhibition "100 Years of Austrian Standards – Shaping the Future“ are also impossible for the time being.

We hope that this challenging time will end soon so that we can welcome you to the House of Standards again soon.

 

Thank you very much for your kind understanding!

Update

FURTHER Information

Our Customer Service (product-related inquiries: +43 1 213 00-300[email protected]) and our Support Line (technical inquiries: +43 1 213 00-888[email protected]) are available for your inquiries as usual during regular office hours.

Our online tools for ordering, applying and managing standards (Webshop, effects, Lesesaal, etc.) are fully accessible as usual.

Committee meetings will continue to be held as web conferences until 20 February 2021. If, in exceptional cases, the committee chair decides that physical or hybrid meetings are necessary, we will inform the members in due time. Therefore, please take note of the information provided by the secretariats of all committees and other bodies.

We carefully monitor ongoing developments and adapt our operations to the current situation.

International Standardization Organizations

ISO: No physical meetings of ISO technical committees or working groups will take place until 30 April 2021 — they will be postponed or held virtually (www.iso.org).

CEN: The CEN-CENELEC Meeting Centre is closed until Friday 29 January 2021 included. More information on the potential re-opening of the Meeting Centre will be circulated during the month of January 2021. CEN and CENELEC continue to hold the meetings online (www.cencenelec.eu).

Presence, online and hybrid seminars

Visit our events at the Austrian Standards Meeting Center or participate online from home. Whether it is a face-to-face seminar, online training or a hybrid event, you can choose in which form you participate. Find our complete range of seminars (German only) at:

www.austrian-standards.at/seminare 

1. Availability and capacity of notified bodies to carry out conformity assessments for COVID-19-related medical devices and in vitro diagnostic medical devices

The following link leads to a document of the European Commission, which provides useful information on the 'Legal framework and route to the market'.

In the Joint European Roadmap towards lifting COVID-19 containment measures adopted on 15 April 2020, the Commission committed to provide information on the availability and capacity of conformity assessment bodies and to share it with market operators. In this context, the Commission conducted a survey with notified bodies in charge of the certification of COVID-19-related medical devices and in vitro diagnostic medical devices earlier this month. These notified bodies can be found via the following link

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf

 

2. EU - Guidance on regulatory requirements for medical face masks - Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance-reg-req-med-face-masks.pdf

FREE Standards

Freely available ISO and IEC standards

To support world-wide efforts in dealing with the COVID-19 crisis, the international standardization organizations ISO and IEC agreed to make available numerous standards on respirators and important medical devices free of charge.

Note: If you have a specific inquiry or any other questions about the available IEC standards, please contact the Austrian Association for Electrical Engineering (OVE) directly.

AFNOR SPEC S76-001 "BARRIER MASKS" Version 1.0

The French standardization body AFNOR has prepared a reference document on the production of mouth-nose protections that is made available for free. Developed for mask manufacturers and individuals, this document provides guidance on the production of masks for healthy people and, thus, complements hygiene procedures that are critical for fighting the COVID-19 pandemic.

Download now.

AFNOR SPEC S76-001 contains:

  • the minimum requirements for industrial, artisanal and private production,
  • the tests to be performed for ensuring the quality of mouth-nose coverings,
  • tips on how to use and clean the masks,
  • preferred materials, dimensions and types of straps.
  • An appendix also contains ready-to-use patterns that can be printed out.

Even though some details of AFNOR SPEC S76-001 are country-specific, Austrian Standards is convinced that this guidance is also valuable for Austria. With AFNOR's friendly consent, we translated the text and the German version is now available for downloading from AFNOR's website.

Note: The European standards (NF EN) listed in the bibliography are available as ÖNORM ENs from Austrian Standards.

We provide you with the following standards at no cost

DOCUMENT NUMBER TITLE

ÖNORM EN 149:2009 07 01

Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking

ÖNORM EN 166:2002 04 01

Personal eye-protection - Specifications

ÖNORM EN 455-1:2001 02 01

Medical gloves for single use - Part 1: Requirements and testing for freedom from holes

ÖNORM EN 455-2:2015 06 01

Medical gloves for single use - Part 2: Requirements and testing for physical properties

ÖNORM EN 455-3:2015 06 01

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

ÖNORM EN 455-4:2009 12 15

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

ÖNORM EN 13795-1:2019 06 01

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

ÖNORM EN 13795-2:2019 06 01

Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits

ÖNORM EN 14126:2004 12 01

Protective clothing - Performance requirements and test methods for protective clothing against infective agents (consolidated version)

ÖNORM EN 14605:2009 06 15

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])

ÖNORM EN 14683:2019 12 01

Medical face masks - Requirements and test methods

ÖNORM EN ISO 374-5:2017 02 01

Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)

ÖNORM EN ISO 5356-1:2015 06 01

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)

ÖNORM EN ISO 10651-4:2009 09 01

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

ÖNORM EN ISO 10993-1:2011 03 15

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)

ÖNORM EN ISO 13688:2013 10 15

Protective clothing - General requirements (ISO 13688:2013)

ÖNORM EN ISO 17510:2020 05 15

Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)

ÖNORM EN ISO 18082:2017 11 15

Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014 + Amd.1:2017) (consolidated version)

NEW: ÖVE/ÖNORM EN ISO 80601-2-12:2020 02 15

Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2020)

ÖNORM EN ISO 80601-2-79:2020 02 15

Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)

ÖNORM EN ISO 80601-2-80:2020 02 15

Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)

FAQ on export requirements for personal protective equipment

On 1 April 2020, the European Commission published a document answering frequently asked questions complementing the Guidance Note published on 20 March 2020. These documents support public authorities and enterprises in the Member States in implementing the export authorization requirements for personal protective equipment introduced on 15 March 2020. These requirements apply temporarily and are in line with all the international obligations of the EU.

Go to the FAQ "Export requirements for personal protective equipment"

IF you have technical questions on the standards, please contact:

Martin Lorenz, Deputy Director Standards Development

Martin Lorenz

Deputy Director Standards Development
Andrea Redelsteiner, Committee Manager

Andrea Redelsteiner

Committee Manager

We are pleased to respond to your inquiries by phone from 8:00 a.m. to 4:30 p.m. from Monday to Thursday and from 8:00 a.m. to 1:00 p.m. on Friday.

 

Sources

Austrian Ministry of Social Affairs, Health, Care and Consumer Protection
Austrian Ministry of the Interior (in German only)
Austrian Broadcasting Corporation ORF (in German only)