BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleanliness requirements
6 Continued process verification
7 Documentation
Annex A (informative) - Sources of harm in the
        cleaning process
Annex B (informative) - Relation between cleaning
        design, validation and risk management
Annex C (informative) - Relation between
        cleaning validation, biological evaluation
        and sterilization validation
Bibliography

BS ISO 19227.

Committee	45
DocumentType	Draft
Pages	22
PublisherName	British Standards Institution
Status	NA

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)
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
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