BS ISO 16428:2005 - Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices – BSI British Standards

BS ISO 16428:2005

Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices

Status : Confirmed, Current   Published : June 2005

Format
PDF

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HARDCOPY



BS ISO 16428:2005 specifies standard environmental conditions for the testing of metallic materials intended for implantation, surgical implants, and medical devices. The test conditions described simulate physiological conditions in a simplified manner controlling the test solution, the temperature, the gaseous atmosphere and the proportions of sample size and volume of solution.

These environmental testing conditions can be employed where necessary in combination with various static or dynamic tests where the effect of the physiological environment is to be considered.

Typical applications are corrosion fatigue tests and selected fretting and wear tests, as well as general electrochemical tests. Typical articulating joint simulator tests and aspects particular to the dental field are not considered by this international standard.

Solutions that attempt to replicate the tribological properties of body fluids,  such as those used in wear studies, are outside the scope of this international standard.




Standard NumberBS ISO 16428:2005
TitleImplants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
StatusConfirmed, Current
Publication Date10 June 2005
Confirm Date14 November 2019
Normative References(Required to achieve compliance to this standard)ISO 3696
Informative References(Provided for Information)ISO 11845:1995, ISO 8044:1999, JIS T 0302, ASTM F 1801:1997, ASTM F 2129:2004
International RelationshipsISO 16428:2005
Draft Superseded By03/305239 DC
DescriptorsImplants (surgical), Fatigue testing, Corrosion tests, Reagent solutions, Environmental testing, Surgical equipment, Wear tests, Prosthetic devices, Metals, Testing conditions, Medical equipment
ICS11.040.40
Title in FrenchImplants chirurgicaux. Solutions d'essai et conditions environnementales pour les essais statiques et dynamiques de corrosion sur les materiaux et dispositifs medicaux implantables
Title in GermanChirurgische Implantate. Testloesung und Umgebungsbedingungen fuer statische und dynamische Korrosions- und Verschleisstests an implantierbaren Materialien und Medizinprodukten
CommitteeCH/150/1
ISBN0 580 45920 9
PublisherBSI
FormatA4
DeliveryYes
Pages18
File Size212 KB
Price£130.00


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