16/30312836 DC : 0
NA
Status of Standard is Unknown
BS ISO 19227 - CLEANING OF ORTHOPEDIC IMPLANTS - GENERAL REQUIREMENTS
Hardcopy , PDF
English
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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 |
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