ISO 13485 (QMS for medical devices)
Also known as: ISO 13485, EN ISO 13485, medical device QMS, medical device quality standard
International QMS standard for manufacturers of medical devices — basis for surgical textiles, protective masks and gowns, harmonised with the EU MDR.
Description
ISO 13485 defines requirements for a quality management system (QMS) for organisations that design, manufacture, install or place medical devices on the market. It was first published in 1996; the currently valid edition is ISO 13485:2016 (3rd edition, published 1 March 2016). In the EU it is harmonised as EN ISO 13485:2016 and, under the Medical Device Regulation MDR (EU) 2017/745, is the central QMS reference for conformity assessment.
Compared with ISO 9001, ISO 13485 does not require “continual improvement” or explicit customer-satisfaction metrics but demands substantially stricter processes for risk management, design control, supplier qualification, traceability (especially for implants), sterilisation validation and CAPA (corrective and preventive action). For the textile industry ISO 13485 is indispensable whenever products are placed on the market as medical devices — for example surgical drapes, surgical gowns, surgical masks (Type IIR), wound dressings and many nursing textiles with a medical purpose.
- Issuer: ISO — current edition 13485:2016
- Harmonised in the EU as EN ISO 13485:2016
- Central QMS reference under the MDR (EU) 2017/745
- Focus: risk management, design control, traceability, sterilisation validation
Properties
| Current edition | ISO 13485:2016 (1 Mar 2016) |
|---|---|
| EU framework | EN ISO 13485:2016, MDR (EU) 2017/745 |
| Textile application | Surgical drapes/gowns, Type IIR masks, nursing textiles |
Related product categories
Sources & references
2- Wikipedia: ISO 13485 Wikipedia — Freie Enzyklopädie https://en.wikipedia.org/wiki/ISO_13485
- ISO 13485 – ISO-Katalogseite ISO — International Organization for Standardization https://www.iso.org/standard/59752.html
