SATRA is open and prioritising the testing and certification of Face Shields, Eyewear, Gloves and Protective Clothing to help contain the COVID-19 Pandemic

SATRA, as a Notified Body for the European PPE Regulation with ISO 17025 accredited testing laboratories, is committed to supporting our customers through these uncertain and difficult times.

The European Commission has asked Notified Bodies to deploy all measures at their disposal to support efforts to increase the supply of PPE during the current COVID-19 outbreak.

SATRA is supporting this drive by providing advice and prioritising the testing and certification of PPE that medical and other key professionals urgently need.

The UK government has just announced a temporary measure that PPE being purchased by the UK Government or NHS (National Health Service) for use by healthcare workers does not need to be subject to the full conformity assessment procedure under European Regulation (EU) 2016/425. It just needs to be manufactured and tested in accordance with a suitable standard or technical specification. SATRA can advise what testing is required and get it done quickly.

The following testing and associated certification, if required, will be prioritised:

Eyewear including Face Shields:

• BS EN 166:2002 Personal eye protection.

Protective Clothing:

• EN 13034:2005+A1:2009 Protective clothing against liquid chemicals. Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)
• EN 14605:2009+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 ISO 13688:2013 Protective clothing. General requirements
• EN 14126:2003 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents

Gloves:

• EN 455-1:2000 Medical gloves for single use. Requirements and testing for freedom from holes
• EN 455-2:2015 Medical gloves for single use. Requirements and testing for physical properties
• EN ISO 374-1:2016+A1:2018 Protective gloves against dangerous chemicals and micro-organisms. Terminology and performance requirements for chemical risks
• EN ISO 374-2:2019 Protective gloves against dangerous chemicals and micro-organisms. Determination of resistance to penetration
• EN ISO 374-4:2019 Protective gloves against dangerous chemicals and micro-organisms. Determination of resistance to degradation by chemicals
• EN 16523-1:2015+A1:2018 Determination of material resistance to permeation by chemicals. Permeation by potentially hazardous liquid chemicals under conditions of continuous contact.

BSI has made a series of European Standards (ENs) for medical devices and personal protective equipment (PPE) used in the context of the current COVID-19 outbreak available without charge.

Click here to apply for free access to the Standards on the BSI website

If you wish to discuss any requirements with SATRA or have any questions in relation to the information supplied above, please contact us:

ppe@satra.com
+44 (0)1536 410000

We would like to take this opportunity to thank everyone within the PPE industry for their exceptional work in keeping our doctors, healthcare staff and front line workers safe – Well done!