ISO 14607:2018
Non-active surgical implants — Mammary implants — Particular requirements
ISO 14607:2018 specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
6.1 General
6.2 Cytotoxicity
6.3 Residual low molecular weight oligomers
6.4 Trace elements
6.5 Physico-mechanical properties and characterization
6.6 Documentation of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.2.1 General
7.2.2 Mechanical tests
7.2.3 Physical evaluation
7.2.4 Chemical evaluation
7.2.5 Biological evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
11.1 General
11.2 Product labelling
11.3 Information for the user
11.3.1 General
11.3.2 Resterilization
11.3.3 Effects on diagnostic techniques
11.4 Marking on implants
11.5 Filling materials
11.6 Information on expected lifetime
11.7 Information for the patient
11.7.1 General
11.7.2 Patient record label
11.7.3 Patient card
Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels
Annex B (normative) Tests for shell integrity
Annex C (normative) Mechanical tests on a mammary implant in its implantable state
Annex D (normative) Test method for valve competence and injection site competence
Annex E (normative) Test for silicone gel cohesion (silicone filling materials only)
Annex F (normative) Test for silicone gel penetration (silicone filling materials only)
Annex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method
Annex H (informative) Test for surface characteristics
Annex I (normative) Information for the user
Annex J (normative) Information for the patient
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 2817:1997
Implants for surgery - Care and handling of orthopaedic implants
-
BS 2574-1:1991
Lower limb orthoses, Guide to the design and manufacture of lower limb orthoses, excluding foot orthoses
-
BS 2574-2:1994
Lower limb orthoses, Specification for hip, knee and ankle joints for lower limb orthoses
-
BS 3531-11:1991
Implants for osteosynthesis, Implants for osteosynthesis. Specification for staples with parallel legs
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Materials
6.1 General
6.2 Cytotoxicity
6.3 Residual low molecular weight oligomers
6.4 Trace elements
6.5 Physico-mechanical properties and characterization
6.6 Documentation of materials
7 Design evaluation
7.1 General
7.2 Pre-clinical evaluation
7.2.1 General
7.2.2 Mechanical tests
7.2.3 Physical evaluation
7.2.4 Chemical evaluation
7.2.5 Biological evaluation
7.3 Clinical evaluation
7.4 Post-market surveillance
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
11.1 General
11.2 Product labelling
11.3 Information for the user
11.3.1 General
11.3.2 Resterilization
11.3.3 Effects on diagnostic techniques
11.4 Marking on implants
11.5 Filling materials
11.6 Information on expected lifetime
11.7 Information for the patient
11.7.1 General
11.7.2 Patient record label
11.7.3 Patient card
Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in silicone gels
Annex B (normative) Tests for shell integrity
Annex C (normative) Mechanical tests on a mammary implant in its implantable state
Annex D (normative) Test method for valve competence and injection site competence
Annex E (normative) Test for silicone gel cohesion (silicone filling materials only)
Annex F (normative) Test for silicone gel penetration (silicone filling materials only)
Annex G (informative) Assessment of silicone diffusion from mammary implants using an in vitro method
Annex H (informative) Test for surface characteristics
Annex I (normative) Information for the user
Annex J (normative) Information for the patient
Bibliography