Coronavirus REsponse

Status on 16 July 2020, 2 p.m.

The measures taken to contain the spread of the coronavirus currently result in world-wide restrictions in the economy and in public life — an exceptional situation that will continue in the coming weeks.

We carefully monitor current developments. If they should require urgent action, we will provide information here.

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 while keeping adverse impacts as low as possible.


Important information while visiting Austrian Standards
 

  • The customer area is open from Monday 8 a.m. to Thursday 3 p.m. and from Friday 8 a.m. to 1 p.m. Access to standards will be possible again.
  • Please comply with the following hygiene measures to contain the spread of the corona virus (COVID-19)
  • Register at the Welcome Desk on the ground floor when you enter the building.
  • The employees of Austrian Standards have switched to teleworking and work from home. To ensure that they can take care of their children, case-by-case solutions have been found. All business trips have been cancelled for the foreseeable future. In all divisions, you can reach us as usual in line with our business contact data.

Update

More 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.

In any case, there will be no physical meetings of standardizing committees and working groups until 30 June 2020. The committee managers will clarify whether meetings can be alternatively held as virtual meetings (web conferencing) or postponed.

Internationale Standardization Organizations

ISO: No physical meetings of ISO technical committees or working groups will take place until 31 Oktober 2020 — they will be postponed or held virtually (www.iso.org).

CEN: Since July 1st 2020 it is possible to organise physical meetings in the Meeting Centre, respecting social distancing and observing other prevention measures (www.cencenelec.eu).

"Kurzarbeit", home office, legal uncertainty in the construction industry:

Mastering the crisis is challenging for all of us. Find answers in our webinars (German only):

www.austrian-standards.at/seminare 

We will start again with selected seminars from June. Of course, in compliance with the current safety precautions. We look forward to welcome you again to Austrian Standards.

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, this notified bodies could be identified 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

AVailable 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.

Go to the list of ISO standards - these standards are freely available in read-only format online.

Go to the list of IEC standards - these standards can be requested by e-mail free of charge, they contain print and text copy restrictions as well as watermarks.
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.

We provide you with the following standards at no cost

Austrian Standards offers you the following EN standards for download:

DOKUMENTNUMMER TITEL

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"

Martin Lorenz, Deputy Director Standards Development

Martin Lorenz

Deputy Director Standards Development
Andrea Redelsteiner, Committee Manager

Andrea Redelsteiner

Committee Manager
Phone: +43121300621