Standard

NS-EN ISO 16671:2015

Withdrawn

Note: This standard has a new edition: NS-EN ISO 16671:2025

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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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2015-08
  • Version: 1
  • Document type: NAT
  • ICS 11.040.70
  • National Committee CEN/TC 170

Legal references

EU law: 93/42/EEC

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