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This part of ISO 13926 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for pen injectors for medical use.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
This part of ISO 17327 specifies general requirements for implant coatings, comprising both surface coatings and surface modifications, applied to non-active surgical implants. This International Standard specifies requirements concerned with generic coating properties.
This International Standard is applicable to surface coatings, i. e. layers of material with any different property than the natural surface of the substrate which are intentionally added to the substrate.
This International Standard is applicable to surface modifications, i. e. intentionally converted or reconstructed surfaces of the original substrate to form a new material consisting of components of the substrate´s own material and foreign material and forming a surface layer with different properties.
This International Standard is not applicable to surfaces modified by texturing with the exclusive intention to change the roughness of the surface or the strength of the raw material.
This International Standard is not applicable to natively passivated metal surfaces. While this International Standard is applicable to intentionally passivated metal surfaces, well-established materials passivated by conventional techniques, such as nitric acid immersion, are usually non-hazardous and can be described in a very basic manner.
This International Standard is not applicable to implant coatings utilizing viable tissue.
This International Standard is not applicable to laminates, i. e. composite materials made of multiple layers, e. g. vascular prosthesis constructed of different expanded polytetrafluoroethylene layers.
This International Standard is not applicable to coverings, e. g. covered stents.
NOTE 1 This International Standard does not contain requirements on biocompatibility. Nevertheless, this is a critical property of the device and coating and needs to be addressed during risk assessment.
NOTE 2 This International Standard supplements applicable non-active surgical implant standards and ISO 14630.
NOTE 3 This International Standard does not require that manufacturers have a quality management system in place. However, the application of a quality management system, such as that described in ISO 13485, could be appropriate to help ensure that the implant achieves its intended performance.
NOTE 4 Although fully porous implants are not coatings, some of the considerations in this document can also be applied to them.
This document specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment, in combination with orthodontic appliances. Orthodontic anchor screws are used to provide temporary intraoral skeletal anchorage during orthodontic therapy and are removed at the end of the orthodontic treatment. Similar to endosseous dental implants, they are, therefore inserted into the maxillo-facial bone structures.
This document gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labelling information.
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are to be implanted in the eye in order to correct aphakia.
This standard specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This standard does not include drainage catheters covered by ISO 20697 Sterile Drainage catheters for single use — e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This standard also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828-97 Standard Specification for ureteral stents.
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components. The catheter is placed in a body cavity or wound surgically or percutaneously for drainage of fluid or air to the exterior.
The drainage catheter is left to drain naturally or connected to suction source for faster tissue granulation.
This document does not apply to:
a) suction catheters;
b) tracheal catheters;.
c) uretheral catheters;
NOTE See ISO 20696.
d) Ureteral stents, biliary stents , and other stents;
NOTE See ISO 14630 and ASTM F1828-97 for stents requirements.
e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
f) neuraxial catheters used for removal of cerebrospinal fluid;
g) enteral Catheters used for removal of solutions or substances from the gastrointestinal tract;