BS ISO 19227:2018 pdf download

BS ISO 19227:2018 pdf download.Implants for surgery—Cleanliness of orthopedic implants— General requirements
1 Scope
This document specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.
This document does not specify requirements for packaging or sterilization which are covered by other International Standards.
This document applies to in-process cleaning and final cleaning.
This document does not apply to liquid or gaseous implants.
This document does not apply to cleaning processes performed by the user or under the responsibility of the user.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 9377-2, Water quality — Determination of hydrocarbon oil index — Part 2: Method using solvent extraction and gas chromatography
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management system
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ASTM D7066-04, Standard Test Method for dimer/trimer of chlorotrifluoroethylene (S-316) Recoverable Oil and Grease and Nonpolar Material by Infrared Determination
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp
A cleaning process is included in the manufacturing process of an implant if hazards relating to possible contaminants, e.g. coming from the previous manufacturing steps, have been identified. As a consequence, design and validation of a cleaning process shall be conducted within a risk management system. Hazards relating to cleaning shall be taken into account during the design of the cleaning process and when establishing design requirements for the critical in-process cleanings and the final cleaning (see 4.3). Annex A identifies some aspects of the cleaning process that can be considered to be sources of harm. Risk assessment of hazards relating to cleaning shall be performed after designing the cleaning process (see 4.3) and shall take into account implant characteristics, manufacturing steps before cleaning, cleaning process characteristics, and the environment implemented after final cleaning. Cleanliness requirements shall be defined (see Clause 5) taking into account the contaminants which are intended to be removed by any in-process or final cleaning as well as additional contaminants introduced by the cleaning process itself.