DS/EN ISO 16061:2009 ( Withdrawn )

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


Status:
Withdrawn
Type:
Standard
Language:
English
Subject:
Replaced by:
Price from:
€ 68.13
Legislation:

Legislation

Harmonized under:
  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:
Links

Scope

This International Standard specifies general requirements for instruments to be used in association with nonactive surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
This International Standard 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, this International Standard gives requirements for intended performance, design
attributes, selection of materials, design evaluation, manufacture, sterilization, packaging and information to be supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants and ophthalmic implants.


Number of pages: 32

Published: 2009-10-12

Date of approval: 2009-09-08

Date of withdrawal: 2015-07-09

International relationships : EN ISO 16061:2009 IDT ISO 16061:2008 IDT

ICS: 11.040.30 - Surgical instruments 11.040.40 - Implants for surgery, prosthetics and orthotics 11.040.99 - Other medical equipment

Item number: M238080


Committees

Committee

  • CEN/TC 285/WG 1
  • ISO/TC 150/WG 7

Danish committee

DS/S-160