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.
| CSA Group | |
|---|---|
| Product Category | Standards and Technical Documents |
| Product Number | ISO 16671:2015 |
| Product Name | Ophthalmic implants - Irrigating solutions for ophthalmic surgery |
