ISO/TS 10993-19:2006
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
Available format(s)
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
Withdrawn date
18-03-2020
Superseded by
Language(s)
English
Published date
19-05-2006
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ISO/TS 10993-19:2006 provides a compilation of parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and the medical device's intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness.
| DocumentType |
Technical Specification
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| Pages |
15
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| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| GOST ISO/TS 10993-19 : 2011 | Identical |
| DD ISO/TS 10993-19:2006 | Identical |
| ANSI/AAMI/ISO TIR10993-19:2006 | Identical |
| GOST R ISO/TS 10993-19 : 2009 | Identical |
| BS ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications Tests for leachables in condensate |
| ISO/TS 20993:2006 | Biological evaluation of medical devices Guidance on a risk-management process |
| AAMI ISO 10993-1 : 2009 : R2013 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| BS ISO 18666:2015 | Traditional Chinese medicine. General requirements of moxibustion devices |
| 06/30106186 DC : 0 | ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM |
| ISO/TR 15499:2016 | Biological evaluation of medical devices Guidance on the conduct of biological evaluation within a risk management process |
| UNE-EN ISO 22442-1:2016 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| DIN EN ISO 22442-1:2016-05 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| BS EN ISO 10993-1 : 2009-10 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| UNE-EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| AAMI/ISO TIR15499:2017 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON THE CONDUCT OF BIOLOGICAL EVALUATION WITHIN A RISK MANAGEMENT PROCESS |
| 17/30344601 DC : 0 | BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 20308:2017 | Traditional Chinese medicine — Gua Sha instruments |
| DIN EN ISO 16061:2015-09 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| BS EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Application of risk management |
| I.S. EN ISO 22442-1:2015 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015) |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| 13/30285624 DC : 0 | BS EN ISO 16061 - INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| 17/30343686 DC : 0 | BS EN ISO 7405 - DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| 17/30319534 DC : 0 | BS ISO 13019 - TISSUE-ENGINEERED MEDICAL PRODUCTS - QUANTIFICATION OF SULPHATED GLYCOSAMINOGLYCANS (SGAG) FOR EVALUATION OF CHONDROGENESIS |
| AAMI ISO 10993-1:2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 13019:2018 | Tissue-engineered medical products — Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis |
| ANSI/AAMI/ISO 22442-1:2016 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
| ISO 18562-4:2017 | Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate |
| DIN EN ISO 10993-1:2010-04 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009) |
| UNI EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| 15/30281262 DC : 0 | BS ISO 18666 - TRADITIONAL CHINESE MEDICINE - GENERAL REQUIREMENTS OF MOXIBUSTION DEVICES |
| PD ISO/TR 15499:2016 | Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process |
| BS ISO 20308:2017 | Traditional Chinese medicine. Gua Sha instruments |
| 16/30319982 DC : 0 | BS ISO 20308 - TRADITIONAL CHINESE MEDICINE - GUA SHA INSTRUMENTS |
| CSA ISO 27427 : 2014 | ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
| ASTM F 3160 : 2016 | Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| ISO 18666:2015 | Traditional Chinese medicine General requirements of moxibustion devices |
| I.S. EN ISO 16061:2015 | INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015) |
| ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants General requirements |
| I.S. EN ISO 10993-1:2009+AC:2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009) |
| BS EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants. General requirements |
| 10/30203224 DC : 0 | BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES |
| BS ISO 27427:2013 | Anaesthetic and respiratory equipment. Nebulizing systems and components |
| PD ISO/TR 37137:2014 | Cardiovascular biological evaluation of medical devices. Guidance for absorbable implants |
| NF EN ISO 10993-1 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| EN ISO 16061:2015 | Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015) |
| ASTM F 1877 : 2016 : REDLINE | Standard Practice for Characterization of Particles |
| ASTM F 2150 : 2013 : REDLINE | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ISO 5832-1:2016 | Implants for surgery — Metallic materials — Part 1: Wrought stainless steel |
| ASTM D 1894 : 2014 : REDLINE | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| ISO 12179:2000 | Geometrical Product Specifications (GPS) Surface texture: Profile method Calibration of contact (stylus) instruments |
| ISO 4287:1997 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions and surface texture parameters |
| ISO 18754:2013 | Fine ceramics (advanced ceramics, advanced technical ceramics) Determination of density and apparent porosity |
| ASTM F 735 : 2017 : REDLINE | Standard Test Method for Abrasion Resistance of Transparent Plastics and Coatings Using the Oscillating Sand Method |
| ISO 13565-3:1998 | Geometrical Product Specifications (GPS) Surface texture: Profile method; Surfaces having stratified functional properties Part 3: Height characterization using the material probability curve |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| EN 623-4:2004 | Advanced technical ceramics - Monolithic ceramics - General and textural properties - Part 4: Determination of surface roughness |
| ISO 17190-5:2001 | Urine-absorbing aids for incontinence Test methods for characterizing polymer-based absorbent materials Part 5: Gravimetric determination of free swell capacity in saline solution |
| ISO/TS 13762:2001 | Particle size analysis Small angle X-ray scattering method |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management |
| ASTM F 732 : 2017 : REDLINE | Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 17853:2011 | Wear of implant materials Polymer and metal wear particles Isolation and characterization |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ASTM D 1044 : 2013 : REDLINE | Standard Test Method for Resistance of Transparent Plastics to Surface Abrasion |
| ISO 5436-2:2012 | Geometrical product specifications (GPS) — Surface texture: Profile method; Measurement standards — Part 2: Software measurement standards |
| ISO 13319:2007 | Determination of particle size distributions Electrical sensing zone method |
| ISO 3274:1996 | Geometrical Product Specifications (GPS) — Surface texture: Profile method — Nominal characteristics of contact (stylus) instruments |
| ISO 18757:2003 | Fine ceramics (advanced ceramics, advanced technical ceramics) — Determination of specific surface area of ceramic powders by gas adsorption using the BET method |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 22442-2:2015 | Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling |
| ISO 5436-1:2000 | Geometrical Product Specifications (GPS) — Surface texture: Profile method; Measurement standards — Part 1: Material measures |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 22442-3:2007 | Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 828:2013 | Adhesives - Wettability - Determination by measurement of contact angle and surface free energy of solid surface |
| ISO 13320-1:1999 | Particle size analysis Laser diffraction methods Part 1: General principles |
| ASTM F 1854 : 2015 : REDLINE | Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants |
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