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Guidance Document EN ISO 15223-1 new symbols for SBS English 2024/09/16

This revision of the guidance document includes learnings from applying the symbols and represents the consensus of the members of the SBA.

Guidance Documents, Symbols 2024/09/16 pdf
SBA considerations on the Commission proposal for a new Packaging and Packaging Waste Regulation English 2023/12/12

SBA Response and comments to the updated proposals for the PPWR issued by the European Commission. Version – December 2023.

2023/12/12 pdf
Moving from MDD to MDR Guidance English 2023-10-04

Guidance on moving from MDD to MDR

Guidance Documents, MDD/MDR 2023-10-04 pdf
SBA considerations on the Commission proposal for a new Packaging and Packaging Waste Regulation English 2023-08-30

SBA Response and comments to the updated proposals for the PPWR issued by the European Commission.

2023-08-30 pdf
SBA Feedback to the PPWR Proposals English 2023/03/20

SBA Response and comments to the updated proposals for the PPWR issued by the European Commission November 2022.

Circular Economy, MDD/MDR, Standards 2023/03/20 pdf
Guidance image to show how symbols may be applied to a double SBS pouched device, contained within a protective package (PP). English October 2021

Following recent requests for guidance on how to apply the new SBS symbols, this image shows a double SBS with an outer PP, and shows the recommended configuration for each layer.

Guidance Documents, MDD/MDR, Prevention of HAI's, Symbols October 2021 PDF
SBA feedback document on the Impact Assessment Study conducted by Eunomia for the European Commission English August 2021

Following a series of webinars presenting the initial assessment by Eunomia of the project they are perfroming for the European Commission in the support of the Packaging and Packaging Waste Directive, the SBA prepared a feedback document, which attempted to highlight the regulatory and patient safety concerns that the proposals presented.

The document was sent to Eunomia on 8th July 2021.

Circular Economy, MDD/MDR, Standards August 2021 PDF
Symbols for SBS – Q&A Symbols document for healthcare professionals 210521 – v2.0 English May 2021

The Sterile Barrier Association (SBA) created and validated new symbols to inform users about the configuration of Sterile Barrier Systems (SBS) respective packaging systems for sterile medical devices. The objective is to assist healthcare users with performing appropriate aseptic technique.

The purpose of this document is to answer the most common questions related to applying the symbols and using packaging which includes these symbols.

Notice

This document is now obsolete. Some or all of the information contained within may be out-of-date or no longer relevant, or the topics discussed may have now been decided or implemented.

Guidance Documents, MDD/MDR, Prevention of HAI's, Standards, Symbols May 2021 PDF
Sรญmbolos para los SBE – Documento de preguntas y respuestas para profesionales del รกmbito sanitario 210521-v2.0 Spanish June 2021

Sterile Barrier Association (SBA) ha creado y validado nuevos sรญmbolos, para informar a los usuarios sobre la configuraciรณn de los Sistemas de Barreras Estรฉril (SBE) en los respectivos sistemas de embalaje de los dispositivos mรฉdicos estรฉriles. El objetivo es ayudar a los usuarios sanitarios para que lleven a cabo una apropiada tรฉcnica asรฉptica.

El propรณsito de este documento es responder las preguntas mรกs comunes relacionadas con la aplicaciรณn de los sรญmbolos y el uso de los embalajes que incluyen estos sรญmbolos.

Guidance Documents, MDD/MDR, Prevention of HAI's, Standards, Symbols June 2021 PDF
Documento Guรญa EN-ISO15223-1 nuevos sรญmbolos para los SBE (Ref: 201908-1 v5.1.2 Spanish) Spanish Feb 2021 (Translation)

Sterile Barrier Associaton (SBA) ha creado y validado nuevos sรญmbolos para los sistemas de barrera estรฉril (SBE), en lo que se refiere a configuraciรณn de sistemas de embalajes para dispositivos mรฉdicos, para incluirlos en la ISO15223-1.

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Guidance Documents, Inspection & Test, MDD/MDR, Prevention of HAI's, Standards, Symbols Feb 2021 (Translation) PDF
ใ‚ฌใ‚คใƒ€ใƒณใ‚น่ณ‡ๆ–™ EN ISO 15223-1 ็„ก่Œใƒใƒชใ‚ขใ‚ทใ‚นใƒ†ใƒ (SBS: Sterile Barrier System)ใฎๆ–ฐใ—ใ„ใ‚ทใƒณใƒœใƒซใซใคใ„ใฆ Japanese June 2021 (Translation)

ๆป…่Œใƒใƒชใ‚ขๅ”ไผš(SBA)ใฏISO 15223-1ใซๅŠ ใˆใ‚‹ใŸใ‚ใซใ€ๆป…่ŒๅŒป็™‚ๆฉŸๅ™จใฎๅŒ…่ฃ…ใ‚ทใ‚นใƒ†ใƒ ใซ้–ขใ™ใ‚‹็„ก่Œใƒใƒชใ‚ขใ‚ทใ‚นใƒ†ใƒ ๏ผˆSBS๏ผ‰ใฎๆ–ฐใ—ใ„ใ‚ทใƒณใƒœใƒซใ‚’ไฝœๆˆใ—ใ€ใƒใƒชใƒ‡ใƒผใ‚ทใƒงใƒณใ—ใพใ—ใŸใ€‚

Guidance-Doc-SYMBOLS-201908-1v5.2_Japanese

Guidance Documents, Inspection & Test, MDD/MDR, Prevention of HAI's, Standards, Symbols June 2021 (Translation) PDF
Review of current legislation and standards affecting Sterile Barrier Systems for the Medical Device Market English 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 English 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 English 2012

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

Notice

This document is now obsolete. Some or all of the information contained within may be out-of-date or no longer relevant, or the topics discussed may have now been decided or implemented.

Circular Economy, Guidance Documents, Standards 2012 PDF
DOCUMENTO INFORMATIVO Transiciรณn del MDD al MDR (Ref. 201708 v1.2 Spanish) Spanish Feb 2021 (Translation)

SBA – Documento informativo que resume y analiza los cambios clave en la transiciรณn del MDD al MDR para los Embalajes Estรฉriles โ€“ 08/2017

Guidance Documents, MDD/MDR, Standards Feb 2021 (Translation) PDF
Guidance Doc – Compatibility of Materials English 2017

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

Notice

This document is now obsolete. Some or all of the information contained within may be out-of-date or no longer relevant, or the topics discussed may have now been decided or implemented.

Guidance Documents, Sterilisation Compatibility 2017 PDF
Interlaboratory Test – Microbial barrier testing of packaging materials for medical devices which are to be sterilised – according to DIN 58953-6:2010 English January 2013

The SBA commissioned independent tests to validate a range of test methods found in the annexes of EN 868 standards to determine their suitability for acceptance into ISO 11607.

Guidance Documents, Inspection & Test, Microbial Barrier, Prevention of HAI's, Standards January 2013 PDF
Paper describing the Validation of Test Methods for Characterizing and Specifying Materials Used in the Construction of Sterilization Packaging English April 2012

Final published paper detailing the SBA commissioned, independent tests, to validate a range of test methods found in the annexes of EN 868 standards to determine their suitability for acceptance into ISO 11607.

Guidance Documents, Inspection & Test, Microbial Barrier, Prevention of HAI's, Standards April 2012 PDF
EN 868 test method validations English August 2010

EN 868 test method validations consultancy report describing the methodology to be employed in order to complete the SBA commissioned, independent test report, to validate a range of test methods found in the annexes of EN 868 standards and determine their suitability for acceptance into ISO 11607.

Guidance Documents, Inspection & Test, Microbial Barrier, Prevention of HAI's, Standards August 2010 PDF