What is ISO 16672 about?
ISO 16672 deals with ophthalmic implants, specifically, ocular endotamponades. Ocular endotamponades are used to reposition and tamponade a detached retina. ISO 16672 specifies requirements for the performance of ocular endotamponades non-active surgical implants. ISO 16672 describes surgically invasive medical devices that are compatible with the internal ocular environment and are used to reposition and tamponade a detached retina.
ISO 16672 applies to ocular endotamponades (OE), which is a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
For the safety and efficacy of ocular endotamponades; ISO 16672 specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labeling, and the information supplied by the manufacturer.
Who is ISO 16672 for?
ISO 16672 on ophthalmic implants is useful for:
- Manufacturers and suppliers of ophthalmic implants
- Manufacturers of ophthalmic implant materials
- Ophthalmologists
- Eyecare/ophthalmic solution companies
- Testing laboratories that include ophthalmic implants service
- Manufacturers of surgically invasive medical devices
Why should you use ISO 16672?
Ophthalmic implants have been widely used to treat all sorts of ophthalmic problems. High quality and biocompatible ocular endotamponades prevent infections, bleeding, and inflammation.
ISO 16672 covers design evaluation of biological safety through tests such as bacterial endotoxins test, intraocular implantation test, and clinical investigation. Design attributes that are discussed include gaseous expansion, interfacial tension, viscosity, molecular mass distribution, particulates, refractive index, spectral transmittance, surface tension and vapour pressure.
By using ISO 16672 guidelines you can improve intended performance, design attributes, pre-clinical, clinical evaluation, safety, and efficacy of ocular endotamponades for end-users.
What’s changed since the last update?
BS EN ISO 16672:2021 supersedes ISO 16672:2015, which has been withdrawn. BS EN ISO 16672:2021 has some significant changes with respect to ISO 16672:2015, these include:
- The following terms and their definitions have been included: "secondary packaging", surgical invasive medical product" and "minimum utilization pressure"
- The subclause on chemical description and contaminants has been substantially revised
- The bacterial endotoxin limit has been revised from 0,5 to 0,2 endotoxin units per ml
- The total level of EO in the product has been revised: it shall not exceed 1,25 μg/dose for EO and 5,0 μg/dose for ethylene chlorohydrin (ECH)
- Minimum utilization pressure has been included in the list of information supplied by the manufacturer
- B.2.2 giving the clinical variables in a clinical investigation has been revised
- Annex c "method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids" has been added