ISO 19227:2018
Current
The latest, up-to-date edition.
Implants for surgery — Cleanliness of orthopedic implants — General requirements
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
French, English
21-03-2018
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ISO 19227:2018 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.
ISO 19227:2018 does not specify requirements for packaging or sterilization which are covered by other International Standards.
ISO 19227:2018 applies to in-process cleaning and final cleaning.
ISO 19227:2018 does not apply to liquid or gaseous implants.
ISO 19227:2018 does not apply to cleaning processes performed by the user or under the responsibility of the user.
| Committee |
ISO/TC 150
|
| DevelopmentNote |
Supersedes ISO/DIS 19227. (03/2018)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Standards | Relationship |
| NF ISO 19227 : 2018 | Identical |
| NEN ISO 19227 : 2018 | Identical |
| IS/ISO 19227 : 2018 | Identical |
| BS ISO 19227:2018 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 3951-1:2013 | Sampling procedures for inspection by variables — Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL |
| ISO 9377-2:2000 | Water quality Determination of hydrocarbon oil index Part 2: Method using solvent extraction and gas chromatography |
| ISO 11737-1:2006 | Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 1484:1997 | Water analysis - Guidelines for the determination of total organic carbon (TOC) and dissolved organic carbon (DOC) |
| ASTM F 3127 : 2016 | Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| NFS 94 091 : 2013 | IMPLANTS CHIRURGICAUX - EXIGENCES DE VALIDATION POUR LE PROCEDE DE NETTOYAGE DES IMPLANTS ORTHOPEDIQUES AVANT CONDITIONNEMENT FINAL |
| EN 13018:2016 | Non-destructive testing - Visual testing - General principles |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| AAMI TIR42 : 2010 | EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES |
| ISO 3951-2:2013 | Sampling procedures for inspection by variables — Part 2: General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics |
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