BS EN ISO 21535:2009+A1:2016 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

BS EN ISO 21535:2009+A1:2016

Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

Status : Current, Under review   Published : October 2009

Format
PDF

Format
HARDCOPY



What is this standard about?

This international standard contains requirements applying specifically to hip joint replacement implants.

Who is this standard for? 

  • Manufacturers and suppliers of non-active surgical implants
  • Testers of non-active surgical implants
  • Medical/healthcare organizations

Why should you use this standard? 

This is a level 3 safety standard for non-active surgical implants, specific to hip replacements. It covers the specific requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and test methods.

What’s changed since the last update?

BS EN ISO 21535 has been systematically reviewed by experts, who have taken into consideration recent technological and industry developments plus changes to medical best practice. Changes include:

  • Amendments to acetabular components and bi-polar heads 
  • Additions to requirements for sterilization and packaging procedures



Standard NumberBS EN ISO 21535:2009+A1:2016
TitleNon-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
StatusCurrent, Under review
Publication Date31 October 2009
Normative References(Required to achieve compliance to this standard)ISO 7206-1, ISO 7206-6, ISO 21534:2007, ISO 14630:2012, ISO 7206-2, ISO 14242-3, ISO 14242-2, ISO 7206-10, ISO 7206-4, ISO 14242-1
Informative References(Provided for Information)ASTM F3047M-15, 93/42/EEC
ReplacesBS EN ISO 21535:2007
International RelationshipsISO 21535:2007/Amd 1:2016,ISO 21535:2007,EN ISO 21535:2009/A1:2016
Amended ByAmendment, January 2017
Draft Superseded By15/30316683 DC
DescriptorsOrthopaedics, Endurance testing, Design, Wear tests, Joints (anatomy), Orthopaedic equipment, Prosthesis, Prosthetic devices, Angles (geometry), Performance testing, Hips, Instructions for use, Dimensional tolerances, Surgical equipment, Marking, Torsion testing, Implants (surgical), Medical equipment
ICS11.040.40
Title in FrenchImplants chirurgicaux non actifs. Implants de remplacement d'articulation. Exigences spécifiques relatives aux implants de remplacement de l'articulation de la hanche
Title in GermanNichtaktive chirurgische Implantate. Implantate zum Gelenkersatz. Besondere Anforderungen an Implantate für den Hüftgelenkersatz
CommitteeCH/150/4
ISBN978 0 580 88908 0
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size652 KB
Price£130.00


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