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ISO 19227:2018

Current
Current

The latest, up-to-date edition.

Implants for surgery — Cleanliness of orthopedic implants — General requirements
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

03-21-2018

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

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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
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ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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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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