SN EN ISO 10993-1:2021

Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschliesslich korrigierte Fassung 2018-10)

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

INB

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient´s body during intended use; — the user´s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Publikation: 2021-04-0155 SeitenICS: 11.100.20

The ISO 10993-1:2018 compliance guidelines are crucial for organizations adopting SN EN ISO 10993-1:2021 to ensure the biological safety of medical devices. This guide will provide a comprehensive overview of the steps needed for compliance and successful implementation.

Why implement SN EN ISO 10993-1:2021 now

Implementing SN EN ISO 10993-1:2021 is essential for organizations in the Healthcare Technology industry due to several driving factors. Firstly, customer requirements often necessitate adherence to recognized standards, particularly in markets where patient safety is paramount. Additionally, regulatory pressure from health authorities mandates compliance to ensure that medical devices are safe and effective. Organizations also pursue these standards as part of their internal quality goals, striving for excellence in product safety and reliability. By aligning with ISO 10993-1:2018 compliance guidelines, companies can enhance their reputation, improve product quality, and ultimately reduce the risk of adverse events.

Prerequisites and readiness check

Before embarking on the path to compliance with SN EN ISO 10993-1:2021, organizations must ensure they are adequately prepared. This involves establishing a solid foundation that includes:

• Management commitment to support the implementation process.
• Resource allocation to ensure sufficient personnel and financial support are available.
• Current process documentation to assess existing procedures and identify areas for improvement.
• Training programs for staff to educate them about the standards and their importance.
• Stakeholder engagement to ensure buy-in from all levels of the organization.

Step 1: Gap analysis

Performing a gap analysis against SN EN ISO 10993-1:2021 is a critical first step in the compliance journey. This process involves identifying discrepancies between current practices and the requirements outlined in the standard. To conduct a gap analysis, organizations should gather relevant inputs, such as existing documentation and stakeholder feedback. The analysis process typically includes reviewing policies, procedures, and practices to determine areas lacking alignment with ISO 10993-1:2018. Common findings may include insufficient documentation of risk management processes or inadequate biological evaluation protocols. Tools such as compliance checklists and assessment matrices can facilitate this analysis, helping organizations pinpoint specific areas for improvement.

Step 2: Design and documentation

After conducting the gap analysis, the next step is to document the management system in alignment with SN EN ISO 10993-1:2021. This includes creating a comprehensive set of documents that clearly outline the organization's scope statement, quality policy, and objectives. Specific procedures and records should be developed to support these elements, ensuring they comply with relevant clauses of the standard. For example:

• The scope statement should define the boundaries of the biological evaluation process.
• The quality policy must reflect a commitment to biocompatibility and patient safety.
• Objectives should be measurable and relevant to the biological evaluation of medical devices.

By meticulously documenting these elements, organizations can ensure a structured approach to compliance, providing clear guidance for all stakeholders involved.

Step 3: Implementation and training

Implementing the management system requires careful planning and execution. Organizations should focus on effective change management strategies to facilitate smooth transitions. This includes conducting training sessions for staff to ensure they understand the new processes and the importance of compliance with ISO 10993-1:2018. Engaging employees in the training process fosters a culture of quality and safety. However, typical pitfalls include insufficient communication about changes and lack of ongoing support for staff. To mitigate these risks, organizations should regularly check in with employees and provide additional resources where needed to promote process adoption.

Step 4: Internal audit and certification

Conducting internal audits is a vital part of the compliance process, helping organizations verify that their management system meets SN EN ISO 10993-1:2021 requirements. These audits should be scheduled regularly, focusing on both documentation and implementation aspects. The certification audit comprises two stages: Stage 1 evaluates documentation to ensure that it aligns with the ISO standards, while Stage 2 assesses the actual implementation of processes within the organization. Successful completion of these audits not only confirms compliance but also identifies areas for continuous improvement, further enhancing biological safety measures in medical devices.

Common pitfalls

Organizations often encounter several common mistakes during the compliance process. Addressing these can significantly improve outcomes:

• Inadequate training: Ensure all staff receive comprehensive training on ISO 10993-1:2018 standards.
• Poor documentation: Maintain thorough and clear records of all processes and evaluations.
• Lack of management support: Secure buy-in from leadership to foster a culture of compliance.
• Insufficient stakeholder engagement: Involve all relevant parties in the implementation process to build consensus.
• Neglecting continuous improvement: Regularly review and update processes to adapt to new regulations and standards.