20/30367075 DC - BS EN ISO 16061. Instruments for use in association with non-active surgical implants. General requirements

20/30367075 DC

BS EN ISO 16061. Instruments for use in association with non-active surgical implants. General requirements

Status : Current, Draft for public comment   Published : January 2020

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This document 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 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 does not apply to the power-driven systems themselves.

With regard to safety, this document gives 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.




Standard Number20/30367075 DC
TitleBS EN ISO 16061. Instruments for use in association with non-active surgical implants. General requirements
StatusCurrent, Draft for public comment
Publication Date16 January 2020
Normative References(Required to achieve compliance to this standard)ISO 14971:2019, ISO 17664:2017, ISO 11135, ISO 8601-1, ISO 17665-1, ISO 10993-1, ISO 11137-3, ISO 80000-1, ISO 11137-1, ISO 14937, ISO 14155, ISO 25424, ISO/TS 13004, ISO 11607-1, ISO 11607-2, ISO 11137-2
Informative References(Provided for Information)ISO 5832-12, ASTM F2052-15, ISO 5832-4, ASTM F136, ASTM F138, ISO 5832-11, IEC 60068-2-27, ASTM B221, ISO 5832-1, IEC 60068-2-31, ISO/TR 20416, ASTM A314, ASTM D7386, ASTM F899, ISO 5832-8, IEC 62570, ASTM D4169, ISO 5832-9, ISO 14708-1, ASTM A276/A276M, ASTM F2063, ISO 7000-DB:2012, ASTM F2213, ISO 5832-6, IEC 62366-1, ISO 4957, ASTM F2503, ISO 5832-2, ISO 5832-5, ISO 5832-14, IEC 60068-2-47, ISO 14630, ISO 5832-3, ISO 5832-7, ISO 7153-1, ASTM A564/A564M, ISO 15223-1:2016
International RelationshipsISO/DIS 16061
Draft Expiry Date10 March 2020
DescriptorsSurgical instruments, Sterilization (hygiene), Production, Austenitic steels, Design, Precipitation hardening, Performance, Grades (quality), Selection, Medical instruments, Stainless steels, Inspection, Implants (surgical), Instructions for use, Compositional tolerances, Surgical equipment, Ferritic steels, Chemical composition, Packaging, Martensitic steels
ICS11.040.40
11.040.99
Title in FrenchInstruments à utiliser en association avec les implants chirurgicaux non actifs — Exigences générales
CommitteeCH/150
PublisherBSI
FormatA4
DeliveryYes
Pages22
File Size380 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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