Coronavirus REsponse

Status on 8 October 2020, 5 p.m.

The measures taken to contain the COVID-19 pandemic continue to severely impact everyday life. Therefore it is important to carefully monitor developments and emphasize the need to respect rules and measures.

Since the first announcements on 10 March 2020, Austrian Standards has acted as foresightedly as possible and, of course, in full compliance with the measures adopted by the Austrian government and the regulatory requirements issued by public authorities. The primary objective is to reduce social contacts as much as possible in order to prevent COVID-19 from spreading.

IMportant information for your visit to Austrian Standards
 

Here you can quickly find all the information you need to get in touch with us or to visit us. Because of the applicable COVID-19 regulations, we kindly ask you to comply with the hygiene rules listed below.

We are available to you by phone during the following hours:

Monday to Thursday from 08.00 a.m. to 4.00 p.m. and
Friday from 08.00 a.m. to 2.30 p.m.

Our Customer Area

where you can browse standards and buy publications is open for you 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.

 

Furthermore, You can contact us as follows:
 

Telephone: +43 1 213 00 0
Email: [email protected]
Austrian Standards, Heinestrasse 38, 1020 Vienna, Austria

appointments and contacting our staff

As a large part of our staff works from home due to COVID-19 precautions, we kindly ask you to get in touch with your contact person to arrange essential appointments at our office. You can reach the team of Austrian Standards as usual via the familiar contact details or our switchboard.

Please comply with the following measures when you visit Austrian Standards at Heinestrasse 38:

Measures have been taken to protect your health.

  • Please go to the Welcome Desk after entering the building and follow the instructions of our staff, e.g. register your contact data.
  • Disinfect your hands after entering the building and wear a mouth-nose mask in public areas or wherever necessary.
  • The number of seats has been reduced in meeting rooms to facilitate compliance with the minimum distance.
  • Numerous disinfectant dispensers have been provided. Please use them.
  • Please always keep the necessary minimum distance of one meter to other persons – especially when you get beverages, coffee or water from the dispensers.
  • Our garage can be used as usual.

Please comply with the following hygiene rules to contain the coronavirus (PDF)

It is imperative to protect your health and the health of others!

We 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 10 January 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 31 January 2021 — they will be postponed or held virtually (www.iso.org).

CEN: Since 1 July 2020 it has been possible to organise physical meetings in the Meeting Centre, respecting social distancing and observing other prevention measures (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
Phone: +43121300621

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)