0 Items
My account
Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

ISO 16061:2008

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

Nov 25, 2008
95.99   Withdrawal of Standard   May 11, 2015

General information

95.99     May 11, 2015

ISO

ISO/TC 150

International Standard

11.040.40     11.040.99  

English   French  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 16061:2000

NOW

WITHDRAWN
ISO 16061:2008
95.99 Withdrawal of Standard
May 11, 2015

CORRIGENDA / AMENDMENTS

ABANDON
ISO 16061:2008/NP Amd 1

REVISED BY

WITHDRAWN
ISO 16061:2015

National adoptions

SRPS EN ISO 16061:2011  
ISS

Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)

95.99   Withdrawal of Standard

Z076 more