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Guidance Document EN ISO 15223-1 new symbols for SBS (Ref: 201908-1 v4) 2019

The Sterile Barrier Association (SBA) created and validated new symbols for Sterile Barrier System (SBS) configurations respective packaging systems for sterile medical devices for inclusion into ISO 15223-1. – 08/2019

Guidance Documents, Symbols 2019 PDF
EU Journal – Common Specifications for the Reprocessing of Single Use Medical Devices August 2020

Common Specifications (CS) on the reprocessing and further re-use of single-use medical devices within a health institution, as foreseen in Articles 17(3) and 17(5) of the Medical Devices Regulation (MDR)

Please note (ref: MedTech Europe – MTE)

  • These CS do not regulate cases where a manufacturer reprocesses another manufacturer’s single-use device for further circulation on the EU market.
  • These CS will regulate cases where
  1. the national law of a given EU Member State permits the reprocessing and further re-use of single-use devices in their own national territory, and where
  2. that Member State decides to allow health institutions to reprocess single-use devices for their own, in-house, re-use, without complying with all ‘manufacturer’ obligations

The Act is available online in all EU languages, here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.273.01.0003.01.ENG&toc=OJ:L:2020:273:TOC

Guidance Documents, MDD/MDR, Standards, Sterilisation Compatibility August 2020 PDF
Results from the SBA validation survey on proposals for new SBS Symbols 2018

Results from the SBA validation study on proposals for new Sterile Barrier System (SBS) symbols for the MDR. – 04/2018

MDD/MDR, Standards, Symbols 2018 PDF
Guidance Notes for Manufacturers of Class 1 Medical Devices 2009

European Union guidance notes for manufacturers of class 1 medical devices. – 06/2009

Guidance Documents, MDD/MDR, Standards 2009 PDF
Review of current legislation and standards affecting Sterile Barrier Systems for the Medical Device Market 2015

SBA review of current relevant legislation and standards affecting Sterile Barrier Systems for the European Medical Device Market – 06/2015

Guidance Documents, MDD/MDR, Standards 2015 PDF
Guidance on Usability of Sterile Barrier Systems for Medical Devices 2015

SBA guidance, use of sterile barrier systems for medical devices to maintain sterility and help prevent Healthcare Associated Infections (HAI’s). – 09/2015

Guidance Documents, Prevention of HAI's, Standards, Sterilisation Compatibility 2015 PDF
Guidance on Packaging & Packaging Waste Directive 2012

SBA position paper on the Packaging and Packaging Waste Directive (94/62/EC) 1994 amended by Directive 2004/12/EC – Essential Requirements. – 04/2012

Circular Economy, Guidance Documents, Standards 2012 PDF
Guidance in the use of Seal Strength Test EN 868-5, Annex D 2015

SBA guidance in the procedures necessary to ensure consistency in results for the EN 868-5 Seal Strength Test. – 02/2015

Guidance Documents, Inspection & Test, Standards 2015 PDF
CE marking of Sterile Barrier Systems 2015

SBA Guidance Document on the CE marking of Sterile Barrier Systems. – 06/2015

Guidance Documents, Standards 2015 PDF
MedTech Europe (MTE) Policy Paper MDR/IVDR Transition 2018

MedTech Europe (MTE) policy paper on the implemention of the new MD and IVD regulations. – 07/2018

Guidance Documents, MDD/MDR, Standards 2018 PDF
MDR Flowchart – MedTech Europe 2017

MedTech Europe (MTE) flowchart detailing the route to achieve MDR compliance. – 12/2017

Guidance Documents, MDD/MDR 2017 PDF
MDR-EN-05_05_2017 2017

Official Journal of the EU for Regulation (EU) 2017/745  & 2017/746  on medical devices and in vitro diagnostic medical devices. – 05/2017

MDD/MDR, Standards 2017 PDF
Moving from the MDD to the MDR – the impact on packaging v1.1 2017

SBA position paper summarising and analysing the key changes in moving from the MDD to the MDR for Sterile Packaging. – 08/2017

Guidance Documents, MDD/MDR, Standards 2017 PDF
Legislation & Standards Affecting Sterile Barrier 2015

SBA review of current relevant legislation and standards affecting Sterile Barrier Systems for the European Medical Device Market. – 06/2015

Guidance Documents, Standards 2015 PDF
Guidance Doc – Compatibility of Materials 2017

SBA guidance document on the compatibility of materials used for Sterile Barrier Systems with sterilisation processes. – 08/2017

Guidance Documents, Sterilisation Compatibility 2017 PDF
SBA commissioned Independent Report on SBS Symbols by Fraunhofer IVV 2019

User understanding of the new SBS symbols to comply with the General Safety and Performance Requirements (GSPR) of the MDR. – 10/2019

MDD/MDR, Standards, Symbols 2019 PDF