BS EN ISO 16672 pdf free download
BS EN ISO 16672:2015 pdf free download.Ophthalmic implants – Ocular endotamponades (ISO 16672:2015).
4 Intended performance
The general requirements for the intended performance of non-active surgical implants specified in Iso 14630 shall apply.
This International Standard describes non-solid medical devices which are compatible with the ocular environment, used to reposition and/or tamponade a detached retina, and which function primarily mechanically. They are used either intra-operatively and removed at the end of surgery, as in the case of heavy liquids such as perfluorocarbons, or are designed to remain in the vitreous cavity until a reattachment of the retina is achieved.
The manufacturer shall describe and document the functional characteristics of the OE in terms of its chemical composition and physical properties, the intended surgical applications, the conditions of use and the maximum duration of contact with, and effects upon, ocular tissues, with particular regard to safety.
The intended performance shall be determined, taking into account published standards, published clinical and scientific literature, validated test results, pre-clinical and clinical evaluation, and clinical investigations.
5 Design attributes
5.1 General
The general requirements for non-active surgical implants specified in Iso 14630 shall apply.
All testing requirements specified below shall be performed with finished, sterilized product, ready for release. Any analytical methods utilized shall be validated.
NOTE Tests described herein are intended to apply when qualifying materials and not necessarily as a routine quality assurance/control programme.
52 Chemical and biological contaminants
The identification of potentially hazardous chemical or biological contaminants shall be determined by a risk analysis. For raw materials of biological origin, these impurities can include proteins, nucleic acids, or other biological materials. Contaminants of the finished product derived from the source materials or from the manufacturing process, such as cross-linking agents and antioxidants, that are potentially hazardous to the tissues of the eye, or systemically, shall be identified and quantified, whenever possible, and their concentration in the finished products reported.
Contaminants shall be determined using standard analytical methods when available, and all methods shall be described. Limits for identified contaminants shall be set and documented. Testing for the biological effects of these contaminants during evaluation of biological safety may be required if the risk analysis determines it necessary.
5.3 Chemical description
The manufacturer shall provide a description of each chemical component in the finished product and its quality specifications. If the component material is derived from biological sources, the organism from which it is obtained shall be stated along with its source. For synthetic polymers, the backbone and end-groups shall be identified. Residual monomers and reaction by-products shall be quantified and identified, if possible.
5.4 Concentration of the components
The concentration of each component material in the finished product shall be stated. Since the testing methodology can affect the actual concentration reported, the physical or chemical techniques utilized shall be described and validated.
5.5 Density
The density of liquid forms of OE shall be specified in kilograms per cubic metre (kg/rn3).
5.6 Gaseous expansion
For gaseous forms of OE the intraocular gaseous expansion at (35 ± 2) °C and its dependence on atmospheric pressure shall he expressed.
5.7 Interfacial tension
Where applicable, the interfacial tension against water shall be expressed in newton per metre (N/rn) at(35±2)°C.
5.8 Kinematic viscosity
Where applicable, the kinematic viscosity at (35 ± 2) °C shall be expressed in millimetres squared per second (mm2/s).
5.9 Dynamic viscosity
For viscous or viscoelastic OE, the dynamic viscosity shall be determined at (35 ± 2) °C in the range between 0,01 and 100 s-1 and expressed in mPas.
5.10 Molecular mass distribution
lithe OE is a polymer, the average molecular mass, the range of molecular mass distribution and the polydispersity shall be reported.
The manufacturer shall conduct and report such additional tests as necessary to provide an adequate description of the molecular mass distribution of the components in the finished product. Whenever possible, standard methods shall be used and specified.
5.11 Partlculates
An assessment of risk shall evaluate the potential for contamination by, or formation of, particulates in the product during manufacture, the conditions expected during transport and storage, and during use of the product and the associated hazards.BS EN ISO 16672 pdf download.
