Standard

NS-EN ISO 16061:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 16061:2021

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Abstract

ISO 16061:2008 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. ISO 16061:2008 also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, ISO 16061:2008 gives requirements for intended performance, design attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-08
  • Version: 1
  • Document type: NAT
  • ICS 11.040.40
  • ICS 11.040.99
  • National Committee CEN/TC 285

Legal references

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

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