The European Commission published Implementing Decision (EU) 2025/2078, amending Implementing Decision (EU) 2021/1182 by adding the following harmonized standards referenced under Regulation (EU) 2017/745:
- EN 13795-1:2025 — Surgical clothing and drapes — Requirements and test methods (Part 1: Surgical drapes and gowns)
- EN 13795-2:2025 — Surgical clothing and drapes — Requirements and test methods (Part 2: Clean air suits)
- EN 14683:2025 — Medical face masks — Requirements and test methods
- EN 14180:2025 — Sterilisers for medical purposes — Low temperature steam and formaldehyde — Requirements and testing
Products conforming to these standards may be presumed to meet the relevant requirements of Regulation (EU) 2017/745. For full text, see the Official Journal: Implementing decision – EU – 2025/2078 – EN – EUR-Lex_
Comparison of Harmonized Standards – EU Decision 2025/2078 vs Previous
This table provides a side-by-side comparison of updated harmonized standards relevant to medical devices under EU MDR. It highlights the changes introduced in the 2025 versions compared to previous standards and outlines the compliance implications for manufacturers and healthcare providers.
| Standard | Previous Version | Summary of Key Changes | Compliance Implications |
| EN 13795-1: 2025 Part 1 | EN 13795-1:2019 | • Quartile-based statistical evaluation. • Revised thresholds for microbial penetration and liquid resistance. • Enhanced guidance on labelling and third-party verification. | • Update validation protocols. • Revise technical documentation. • Ensure notified body alignment. |
| EN 13795-2: 2025 Part 2 | EN 13795-2:2019 | • Expanded guidance for labelling and third-party verification. • Quartile-based statistics for test results. • Clearer differentiation for single-use vs reusable suits. | • Update test protocols. • Revise product specifications. • Align documentation with MDR requirements. |
| EN 14683: 2025 | EN 14683: 2019 | • Bioburden extrapolated to 300 ml. • Breathability units changed to Pa. • Tighter instrument accuracy. • Broader BFE challenge range; AQL 4% removed. | • Retest products. • Update declarations and risk assessments. • Adjust quality control procedures. |
| EN 14180: 2025 | EN 14180: 2014 | • Clarified scope for below ambient pressure. • Expanded design and performance specifications. • Enhanced validation protocols • Standardized testing procedures. | • Ensure design compliance. • Revalidate sterilization cycles. • Update user manuals and installation qualifications. |
References
[2] ttesting.org
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