| Name (Click to view) | Language | Filter By | Description | Categories | Date | Type | Download |
|---|---|---|---|---|---|---|---|
| Packaging Symbols Poster | English | 2025/03/12 | This poster provides guidance to healthcare professionals and medical device manufacturers on the symbols used to label different types of sterile barrier systems and protective packaging. |
Guidance Documents, Symbols | 2025/03/12 | ||
| SBA Reflection Paper on Environmental Sustainability | English | 2025/01/30 | This reflection paper addresses the environmental sustainability of healthcare packaging, specifically emphasising |
Circular Economy, Guidance Documents | 2025/01/30 | ||
| Annual Report 2024 | English | 2025/01/16 | This SBA Annual Report 2024 is an official review of the activities and achievements of the Sterile Barrier |
Annual Report | 2025/01/16 | ||
| 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 | ||
| 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 | |||
| Moving from MDD to MDR Guidance | English | 2023-10-04 | Guidance on moving from MDD to MDR |
Guidance Documents, MDD/MDR | 2023-10-04 | ||
| 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 | |||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 | ||
| Símbolos para los SBE – Documento de preguntas y respuestas para profesionales del ámbito sanitario 210521-v2.0 | Spanish | June 2021 | Sterile Barrier Association (SBA) ha creado y validado nuevos símbolos, para informar a los usuarios sobre la configuración de los Sistemas de Barreras Estéril (SBE) en los respectivos sistemas de embalaje de los dispositivos médicos estériles. El objetivo es ayudar a los usuarios sanitarios para que lleven a cabo una apropiada técnica aséptica. El propósito de este documento es responder las preguntas más comunes relacionadas con la aplicación de los símbolos y el uso de los embalajes que incluyen estos símbolos. |
Guidance Documents, MDD/MDR, Prevention of HAI's, Standards, Symbols | June 2021 | ||
| Documento Guía EN-ISO15223-1 nuevos símbolos para los SBE (Ref: 201908-1 v5.1.2 Spanish) | Spanish | Feb 2021 (Translation) | Sterile Barrier Associaton (SBA) ha creado y validado nuevos símbolos para los sistemas de barrera estéril (SBE), en lo que se refiere a configuración de sistemas de embalajes para dispositivos médicos, para incluirlos en la ISO15223-1.
|
Guidance Documents, Inspection & Test, MDD/MDR, Prevention of HAI's, Standards, Symbols | Feb 2021 (Translation) | ||
| ガイダンス資料 EN ISO 15223-1 無菌バリアシステム(SBS: Sterile Barrier System)の新しいシンボルについて | Japanese | June 2021 (Translation) | 滅菌バリア協会(SBA)はISO 15223-1に加えるために、滅菌医療機器の包装システムに関する無菌バリアシステム（SBS）の新しいシンボルを作成し、バリデーションしました。 Guidance-Doc-SYMBOLS-201908-1v5.2_Japanese |
Guidance Documents, Inspection & Test, MDD/MDR, Prevention of HAI's, Standards, Symbols | June 2021 (Translation) | ||
| 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 | ||
| 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 | ||
| 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 – 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 | ||
| DOCUMENTO INFORMATIVO Transición 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 transición del MDD al MDR para los Embalajes Estériles – 08/2017 |
Guidance Documents, MDD/MDR, Standards | Feb 2021 (Translation) | ||
| 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 | ||
| 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 | ||
| 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 | ||
| 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 |
