Standard

NS-EN ISO 16672:2015

Withdrawn

Note: This standard has a new edition: NS-EN ISO 16672:2021

Corrigendums and amendments are bought separately.

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Abstract

ISO 16672:2015 applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina. With regard to the safety and efficacy of OE, this International Standard specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

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  • Withdrawn: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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