BS EN ISO 14607:2018,Non-active surgical implants – Mammary implants – Particular requirements.BS EN ISO 14607:2018 pdf free download.
There are three levels of International Standards dealing with non-active surgical implants. These are as follows (with level 1 being the highest):
—Level 1: General requirements for non-active surgical implants;
—Level 2: Particular requirements for families of non-active surgical implants;
—Level 3: Specific requirements for types of non-active surgical implants.
nis document is a level 2 standard and contains particular requirements for a family of mammary implants.
The level 1 standard, ISO 14630, 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.
To address all requirements, the lowest available level is the level to start with.
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.
6.1 General
The requirements of 1S0 14630: 2012, Clause 6, shall apply.
Materials shall be manufactured and tested under a quality management system.
The information stated within Clause 6 shall be available from the manufacturer.
NOTE: This information can typically be obtained from the raw material supplier. When other materials than silicone are used, the manufacturer shall establish suitable test methods and acceptance criteria to demonstrate the appropriate performance and safety of the implant.
6.2 cytotoxicity
The components of each production raw material lot shall be cured and tested for cytotoxicity in accordance with ISO 10903-5. No cytotoxic effects, as defined in ISO 10923-5, shall be induced by the material tested, or throughout the culture.
6.3 Residual low molecular weight oligomers
The combined residual oligomers, cyclotetrasiloxane(D4) and cyclopentasiloxane (D5),in uncured or cured gel shall be tested in accordance with Annex A.
6.4 Trace elements
The components of each production raw material lot shall be in accordance with the Table 1 specifications on metal impurities.