ISO 19227 : 2018

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IMPLANTS FOR SURGERY - CLEANLINESS OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS

Publisher: International Organization for Standardization

Published: 01-01-2018

Available Formats: PDF - English, Hardcopy - English, PDF - French, Hardcopy - French
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleanliness evaluation - Test methods and
  cleanliness acceptance criteria after final cleaning
6 Continued process verification
7 Documentation
Annex A (informative) - Potential sources of harm
        in a cleaning process
Annex B (informative) - Relation between cleaning
        process design, validation and risk management
Annex C (informative) - Relation between cleaning
        validation, biological evaluation and
        sterilization validation
Bibliography

Abstract - (Show below) - (Hide below)

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.

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Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 150

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
DS/ISO 19227:2018	Identical
NF ISO 19227 : 2018	Identical
NEN ISO 19227 : 2018	Identical
ABNT NBR ISO 19227:2019	Identical
NEN ISO 19227 : 2018	Identical
DS/ISO 19227:2018	Identical
ABNT NBR ISO 19227:2019	Identical
NF ISO 19227 : 2018	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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 10993-5 : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
ASTM D 7066 : 2004	TEST METHOD FOR DIMER/TRIMER OF CHLOROTRIFLUOROETHYLENE (S-316) RECOVERABLE OIL AND GREASE AND NONPOLAR MATERIAL BY INFRARED DETERMINATION
ISO 9377-2 : 2000(R2016)	WATER QUALITY - DETERMINATION OF HYDROCARBON OIL INDEX - PART 2: METHOD USING SOLVENT EXTRACTION AND GAS CHROMATOGRAPHY
ISO 11737-1 : 2006	STERILIZATION OF HEALTH CARE PRODUCTS - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
ISO 13485 : 2016(R2020)	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
AAMI ST72 : 2011	BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
ASTM F 2459 : 2012-03	TEST METHOD FOR EXTRACTING RESIDUE FROM METALLIC MEDICAL COMPONENTS AND QUANTIFYING VIA GRAVIMETRIC ANALYSIS
ISO 10993-12 : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS
ISO 10993-17 : 2002(R2016)	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(R2010)	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
AAMI TIR42 : 2010	EVALUATION OF PARTICULATES ASSOCIATED WITH VASCULAR MEDICAL DEVICES
ISO 3951-2 : 2013(R2018)	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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ISO 19227 : 2018

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