PRICES include / exclude VAT
Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.40 Implants for surgery, prosthetics and orthotics>BS EN ISO 16061:2021 Instruments for use in association with non-active surgical implants. General requirements
immediate downloadReleased: 2021-04-06
BS EN ISO 16061:2021 Instruments for use in association with non-active surgical implants. General requirements

BS EN ISO 16061:2021

Instruments for use in association with non-active surgical implants. General requirements

CURRENCY
LANGUAGE
English
Standard number:BS EN ISO 16061:2021
Pages:24
Released:2021-04-06
ISBN:978 0 580 51548 4
Status:Standard
DESCRIPTION

BS EN ISO 16061:2021


This standard BS EN ISO 16061:2021 Instruments for use in association with non-active surgical implants. General requirements is classified in these ICS categories:
  • 11.040.99 Other medical equipment
  • 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies the 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 supplied after refurbishment.

NOTE

In this document, unless otherwise specified, the term “ instrument” refers to an instrument for use in association with non-active surgical implants.

This document also applies to instruments which can be connected to power-driven systems, but it does not apply to the power-driven systems themselves.

With regard to safety, this document gives the requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the instrument manufacturer, hereafter referred to as the manufacturer.

This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.


This product includes: