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
