BS EN ISO 21534:2009 - Non-active surgical implants. Joint replacement implants. Particular requirements – BSI British Standards
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BS EN ISO 21534:2009

Non-active surgical implants. Joint replacement implants. Particular requirements

Status : Under review, Current   Published : October 2009
Conformity to regulation : Designated

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BS EN ISO 21534:2009 Non-active surgical implants. Joint replacement implants. Particular requirements

There are three levels of international standard dealing with non-active surgical implants. These are as follows, with level 1 being the highest:

Level 1: BS EN ISO14630 - General requirements for non-active surgical implants and instrumentation used in association with implants
Level 2: BS EN ISO21534 - Particular requirements for families of non-active surgical implants
Level 3: BS EN ISO 21535 - Specific requirements for types of non-active surgical implant.

BS EN ISO 21534 is a level 2 standard and contains requirements that apply to all non-active surgical implants in the family of joint replacement implants.

The level 1 standard contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. The level 1 standard has been published as ISO 14630.

Level 3 standards apply to specific types of implants within a family, such as knee and hip joints. To address all requirements, it is recommended that a standard of the lowest available level be consulted first.

This international standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of BS EN ISO 14630, artificial ligaments and their associated fixing devices are included in the term "implant".

It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Contents of BS EN ISO 21534 contain

  • Scope
  • Normative references
  • Terms and definitions
  • Intended performance
  • Design attributes
  • Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE)
  • Surface finish of metallic or ceramic partial implants
  • Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE
  • Surfaces of spherically-conforming metallic or ceramic partial implants
  • Surfaces of concave, spherically-conforming UHMWPE components
  • Materials
  • Dissimilar metals or alloys
  • Design evaluation
  • Preclinical evaluation
  • Clinical investigation
  • Post market surveillance
  • Manufacture and inspection
  • Metal surfaces
  • Plastic surfaces
  • Ceramic surfaces
  • Sterilization
  • Expiry
  • Packaging
  • Information supplied by the manufacturer
  • Labelling of implants for use on one side of the body only
  • Instructions for orientation of implants
  • Markings for orientation of the implants
  • Placing of markings on implants
  • Restrictions on use
  • Re-sterilization of zirconia ceramics
  • Labelling of implants for use with or without bone cement
  • List of International Standards for materials found acceptable for the manufacture of implants
  • List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants



Standard NumberBS EN ISO 21534:2009
TitleNon-active surgical implants. Joint replacement implants. Particular requirements
StatusUnder review, Current
Publication Date31 October 2009
Conformity to regulationDesignated
Confirm Date20 June 2016
Normative References(Required to achieve compliance to this standard)ISO 14155-1, ISO 4287, ISO 7206-8, ISO 14242-2, ISO 7206-4, ISO 14242-1, ISO 14879-1, ISO 14630, ISO 14243-2
Informative References(Provided for Information)BS 6324-2, ASTM F1223, ASTM F897, ISO 5832-11, ASTM F1147, ISO/TR 9325, ISO 8828, BS 6324-5, ISO 9584, BS 6324-3, ISO 7206-6, ISO 5833, ASTM F370, ASTM F1378, ASTM F997, ISO 9583, ISO 7206-2, ISO 7207-2, ISO 5832-12, NF S 94-065, ISO 14243-1, ISO 5832-9, NF S 94-167, ISO 13356, ISO 14243-3, ASTM F746, 93/42/EEC, ISO/TR 9326, ISO 7206-1, ASTM F1357, ASTM F1185, BS 6324-1, ISO 7207-1, ISO 13779-4:2018, ISO 5832-7, ISO 5832-1, BS ISO 13779-2:2018, ISO 13779-2:2018, ISO 5832-6, ISO 5834-2, ISO 5832-4, ISO 5832-3, ISO 6474, ISO 5832-5, ISO 5834-1, BS ISO 13779-4:2018, ISO 5832-2, ISO 5832-8, ISO 13779-1, BS 6324-4, ASTM F604
ReplacesBS EN ISO 21534:2007
International RelationshipsISO 21534:2007,EN ISO 21534:2009
DescriptorsInspection, Metals, Sterilization (hygiene), Compatibility, Non-metals, Performance, Prosthetic devices, Joints (anatomy), Surface texture, Implants (surgical), Instructions for use, Marking, Life (durability), Orthopaedic equipment, Alloys, Medical equipment
ICS11.040.40
Title in FrenchImplants chirurgicaux non actifs. Implants de remplacement d'articulation. Exigences particulières
Title in GermanNichtaktive chirurgische Implantate. Implantate zum Gelenkersatz. Besondere Anforderungen
CommitteeCH/150/4
ISBN978 0 580 68118 9
PublisherBSI
FormatA4
DeliveryYes
Pages24
File Size747 KB
Price£186.00


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