BAS EN ISO 16671:2016
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
General Information
Status: Published
No. of pages: 28
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 18.05.2016
Technical committee:
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 16671:2015, identical
- ISO 16671:2015, identical