SFS-EN ISO 21534:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant".
ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes

5.1 General
5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE)
5.3 Surface finish of metallic or ceramic partial implants
5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE
5.5 Surfaces of spherically-conforming metallic or ceramic partial implants
5.6 Surfaces of concave, spherically-conforming UHMWPE components

6 Materials

6.1 General
6.2 Dissimilar metals or alloys

7 Design evaluation

7.1 General
7.2 Preclinical evaluation
7.3 Clinical investigation
7.4 Post market surveillance

8 Manufacture and inspection

8.1 General
8.2 Metal surfaces
8.3 Plastic surfaces
8.4 Ceramic surfaces

9 Sterilization

9.1 General
9.2 Expiry

10 Packaging
11 Information supplied by the manufacturer

11.1 General
11.2 Labelling of implants for use on one side of the body only
11.3 Instructions for orientation of implants
11.4 Markings for orientation of the implants
11.5 Placing of markings on implants
11.6 Restrictions on use
11.7 Re-sterilization of zirconia ceramics
11.8 Labelling of implants for use with or without bone cement

Annex A List of International Standards for materials found acceptable for the manufacture of implants (informative)
Annex B List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants (informative)
Annex C List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes

5.1 General
5.2 Surface finish of metallic or ceramic implants articulating on ultra-high-molecular-weight polyethylene (UHMWPE)
5.3 Surface finish of metallic or ceramic partial implants
5.4 Surfaces of convex, spherically-conforming metallic or ceramic implants articulating on UHMWPE
5.5 Surfaces of spherically-conforming metallic or ceramic partial implants
5.6 Surfaces of concave, spherically-conforming UHMWPE components

6 Materials

6.1 General
6.2 Dissimilar metals or alloys

7 Design evaluation

7.1 General
7.2 Preclinical evaluation
7.3 Clinical investigation
7.4 Post market surveillance

8 Manufacture and inspection

8.1 General
8.2 Metal surfaces
8.3 Plastic surfaces
8.4 Ceramic surfaces

9 Sterilization

9.1 General
9.2 Expiry

10 Packaging
11 Information supplied by the manufacturer

11.1 General
11.2 Labelling of implants for use on one side of the body only
11.3 Instructions for orientation of implants
11.4 Markings for orientation of the implants
11.5 Placing of markings on implants
11.6 Restrictions on use
11.7 Re-sterilization of zirconia ceramics
11.8 Labelling of implants for use with or without bone cement

Annex A List of International Standards for materials found acceptable for the manufacture of implants (informative)
Annex B List of International Standards for materials found acceptable or not acceptable for articulating surfaces of implants (informative)
Annex C List of materials found acceptable or non-acceptable for metallic combinations for non-articulating contacting surfaces of implants (informative)

Bibliography

Tuoteryhmä(t)

11.040.40 Kirurgiset implantit, proteesit ja ortoosit »

Sidokset

Velvoittavat viittaukset

ISO 14155-1:2003 Clinical investigation of medical devices for human subjects -- Part 1: General requirements
ISO 14242-1:2002 Implants for surgery -- Wear of total hip-joint prostheses -- Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 14242-2:2000 Implants for surgery -- Wear of total hip-joint prostheses -- Part 2: Methods of measurement

Tekninen komitea

CEN/TC 285 Non-active surgical implants »

Direktiivi

93/42/EEC Lääkinnälliset laitteet
2007/47/EC Aktiiviset implantoitavat lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

12.10.2009

Julkaisupäivä

30.10.2009

Painos

2

Sivumäärä

19

Julkaisun kieli

englanti