Standard

NS-EN ISO 15798:2013

Withdrawn

Note: This standard has a new edition: NS-EN ISO 15798:2022

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Abstract

ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery. ISO 15798:2013 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2013-09
  • Version: 1
  • Document type: NAT
  • ICS 11.040.70
  • National Committee CEN/TC 170

Legal references

EU law: 93/42/EEC, 2007/47/EC

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