DIN EN ISO 14971 (medical risk management)
Also known as: ISO 14971, Medical device risk management
International standard for risk management of medical devices — mandatory for producers of medical textiles such as surgical gowns, drapes and compresses.
Description
DIN EN ISO 14971 (current edition 2019-12) sets out principles, terminology and a structured process for risk management across the full life cycle of medical devices — from design through manufacture and market phase to decommissioning. The standard is harmonised under the EU Medical Device Regulation MDR (EU) 2017/745 and is a central evidence tool for CE conformity.
For medical textiles — surgical gowns, drapes, sterile clean-room clothing, wound dressings — this means the manufacturer must systematically document risk analysis, risk evaluation, risk control and residual risk assessment. The standard names three protective strategies: 1) inherently safe design (e.g. tear-resistant fasteners), 2) protective measures on the product (e.g. seam sealing against fluid penetration), 3) information for safety (labelling, instructions for use). The 2019 edition added the concept of benefit-risk ratio.
- Current: DIN EN ISO 14971:2019, harmonised under MDR (EU) 2017/745
- Mandatory part of the technical documentation for CE marking
- Three-tier protective strategy: design, protective measure, information
- Relevant for textiles in surgical, sterile and wound-care applications
Properties
| Edition | DIN EN ISO 14971:2019-12 |
|---|---|
| EU legal framework | MDR (EU) 2017/745 |
| Process steps | Analysis — evaluation — control — residual risk |
| Textile relevance | Surgical gowns, drapes, wound dressings, clean-room clothing |
Related product categories
Sources & references
2- Wikipedia: ISO 14971 Wikipedia — Freie Enzyklopädie https://en.wikipedia.org/wiki/ISO_14971
- Beuth Verlag: DIN EN ISO 14971 Beuth Verlag / DIN https://www.beuth.de/de/norm/din-en-iso-14971/319157854
