ISO 19227:2018 手術用インプラント—整形外科用インプラントの清潔さ—一般的な要件 | ページ 6

3.1

cleaning

removal of contaminants (3.4) from an item to the extent necessary for further processing or for intended use

Note 1 to entry: Contaminants (3.4) present on the surface of an implant can be removed by mechanical, physical and/or chemical means. The ability of an implant to be cleaned can depend on many factors, especially: the chemical nature of the surface of the implant, the chemical nature of contaminants, the cleaning process (3.3) , the design of the implants (for example, assembled surfaces, blind holes, small-diameter and long holes impair cleanability), morphology of the surface of the implant and porosities.

3.2

cleaning family

3.3

cleaning process

set of technologies, including the required equipment and the defined sequence of cleaning steps (cleaning programs), the procedures (cleaning procedures, including handling), and the controls (cleaning controls)

3.4

contaminant

biological, chemical or physical substance on the implant that can impair the safety or the performance of the implant

3.5

final cleaning

cleaning (3.1) just before the implant is protected against further contamination before distribution

Note 1 to entry: For implants delivered sterile, the final cleaning is the cleaning just before the implant is protected against further contamination and sterilized by the manufacturer.

Note 2 to entry: For implants delivered non-sterile, the final cleaning is the cleaning just before the implant is protected against further contamination and delivered to the user, who will be responsible for sterilization.

3.6

in-process cleaning

cleaning (3.1) performed between two manufacturing steps in order to remove the contamination coming from previous manufacturing steps

Note 1 to entry: For example, if an implant is manufactured with the following steps: machining, cleaning 1, dimensional control, polishing, cleaning 2, laser marking, inspection, final cleaning (3.5) , packaging in clean room and sterilization, then “cleaning 1” and “cleaning 2” are in-process cleanings.

Note 2 to entry: In-process cleaning is meant to include cleaning on raw materials or semi-finished products entering the manufacturing process.

3.7

critical in-process cleaning

in-process cleaning (3.6) defined to be essential for the final cleanliness of the implant

3.8

worst-case specimen

implant of a cleaning family (3.2) or test dummy/dummies, being representative of a cleaning family and having the highest risk to be in a contaminated state when the cleaning process has been completed, taking into account the nature and quantity of each type of contaminant (3.4) before cleaning and the ability of the implants of the family to be cleaned

Note 1 to entry: The nature and quantity of each type of contaminant (3.4) are typically related to production and cleaning processes.

Note 2 to entry: The ability of the implant to be cleaned is typically related to material(s), geometry and surface texture.

Note 3 to entry: Test dummies are manufactured with comparable processing method(s) and materials, and using the same installations and parameters for cleaning, packaging and sterilization (if applicable) that are used for the implants of the cleaning family.

Note 4 to entry: In the context of this document the term “worst-case specimen” always refers to cleaning, and should not be confused with worst-case specimen for other purposes (e.g. for sterilization).

3.9

cleanliness

state of an implant with levels of contaminants (3.4) below specified criteria

3.10

validation

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE:ISO/TS 11139:2006, 2.55]

3.11

exhaustive extraction

extraction, typically accomplished using multiple steps, that solubilizes the total amount of extractable substances present in a test article, as evidenced when the amount of extractables released in a subsequent extraction step is less than 10 % of the amount of extractables released in the first extraction step