ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
Status: Under development
Technical Committee: ISO/TC 172/SC 7 Ophthalmic optics and instruments
- ICS :
- 11.040.70 Ophthalmic equipment
This standard contributes to the following Sustainable Development Goals:
ISO 16671:2015/Amd 1:2017
ISO/CD 16671Stage: 30.20
Got a question?
Check out our FAQs
+41 22 749 08 88
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.