Name (Click to view) | Language | Description | Date | Type | Download |
---|---|---|---|---|---|
Guidance Document EN ISO 15223-1 new symbols for SBS | English | This revision of the guidance document includes learnings from applying the symbols and represents the consensus of the members of the SBA. |
2024/09/16 | ||
SBA considerations on the Commission proposal for a new Packaging and Packaging Waste Regulation | English | SBA Response and comments to the updated proposals for the PPWR issued by the European Commission. Version – December 2023. |
2023/12/12 | ||
Moving from MDD to MDR Guidance | English | Guidance on moving from MDD to MDR |
2023-10-04 | ||
SBA considerations on the Commission proposal for a new Packaging and Packaging Waste Regulation | English | SBA Response and comments to the updated proposals for the PPWR issued by the European Commission. |
2023-08-30 | ||
SBA Feedback to the PPWR Proposals | English | SBA Response and comments to the updated proposals for the PPWR issued by the European Commission November 2022. |
2023/03/20 | ||
Guidance image to show how symbols may be applied to a double SBS pouched device, contained within a protective package (PP). | English | 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. |
October 2021 | ||
SBA feedback document on the Impact Assessment Study conducted by Eunomia for the European Commission | English | 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. |
August 2021 | ||
Symbols for SBS – Q&A Symbols document for healthcare professionals 210521 – v2.0 | English | 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. |
May 2021 | ||
Sรญmbolos para los SBE – Documento de preguntas y respuestas para profesionales del รกmbito sanitario 210521-v2.0 | Spanish | 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. |
June 2021 | ||
Documento Guรญa EN-ISO15223-1 nuevos sรญmbolos para los SBE (Ref: 201908-1 v5.1.2 Spanish) | Spanish | 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. ย |
Feb 2021 (Translation) | ||
ใฌใคใใณใน่ณๆ EN ISO 15223-1 ็ก่ใใชใขใทในใใ (SBS: Sterile Barrier System)ใฎๆฐใใใทใณใใซใซใคใใฆ | Japanese | ๆป ่ใใชใขๅไผ(SBA)ใฏISO 15223-1ใซๅ ใใใใใซใๆป ่ๅป็ๆฉๅจใฎๅ ่ฃ ใทในใใ ใซ้ขใใ็ก่ใใชใขใทในใใ ๏ผSBS๏ผใฎๆฐใใใทใณใใซใไฝๆใใใใชใใผใทใงใณใใพใใใ Guidance-Doc-SYMBOLS-201908-1v5.2_Japanese |
June 2021 (Translation) | ||
Review of current legislation and standards affecting Sterile Barrier Systems for the Medical Device Market | English | SBA review of current relevant legislation and standards affecting Sterile Barrier Systems for the European Medical Device Market – 06/2015 |
2015 | ||
Guidance on Usability of Sterile Barrier Systems for Medical Devices | English | SBA guidance, use of sterile barrier systems for medical devices to maintain sterility and help prevent Healthcare Associated Infections (HAI’s). – 09/2015 |
2015 | ||
Guidance on Packaging & Packaging Waste Directive | English | 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. |
2012 | ||
DOCUMENTO INFORMATIVO Transiciรณn del MDD al MDR (Ref. 201708 v1.2 Spanish) | Spanish | SBA – Documento informativo que resume y analiza los cambios clave en la transiciรณn del MDD al MDR para los Embalajes Estรฉriles โ 08/2017 |
Feb 2021 (Translation) | ||
Guidance Doc – Compatibility of Materials | English | 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. |
2017 | ||
Interlaboratory Test – Microbial barrier testing of packaging materials for medical devices which are to be sterilised – according to DIN 58953-6:2010 | English | 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. |
January 2013 | ||
Paper describing the Validation of Test Methods for Characterizing and Specifying Materials Used in the Construction of Sterilization Packaging | English | 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. |
April 2012 | ||
EN 868 test method validations | English | 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. |
August 2010 |