ISO 10993-1 “THE EARLY YEARS”
JAMES M ANDERSON, MD, PHDDISTINGUISHED UNIVERSTIY PROFESSOR
DEPARTMENTS OF PATHOLOGY, BIOMEDICAL ENGINEERING, AND MACROMOLECULAR SCIENCE
CASE WESTERN RESERVE UNIVERSITYCLEVELAND, OHIO
DISCLOSURES
• AD HOC CONSULTANT FOR CR BARD, INC.
• CONVENER FOR ISO 10993-1 (1987-2019)
• AD HOC CONSULTANT FOR MEDTRONIC CARDIOVASCULAR
• AD HOC CONSULTANT FOR DURECT, INC.
CONTRIBUTORS
Raju Kammula Jack Lemons Don Marlowe Jennifer Good Jeremy Tinkler Jon CammackArne Hensten Arthur BrandwoodDavid Mueller
“EARLY PLAYERS”
Don Gibbons Paul UpmanStephen Perren Richard WallinEd Muller Roger DabbahSharon Northrup Emanuel HorowitzMarie-Francoise HarmandPaul Didisheim Robert PryzgodaDan McLain A. Nakamura
ISO/TC 194 WG 1
• FDA TOXICOLOGY SUBGROUP SEPT., 1984(510K, PMA, IDE)
• TRIPARTITE BIOCOMPATIBILITY GUIDANCE SEPT., 1986
• PFORZHEIM, W. GERMANY 1989
• LONDON, UK JAN 31-FEB 1 1990
• ISO 10993-1 1992
EARLY CHAIRS, ISO/TC 194
STEPHEN PERREN, SWITZERLANDLAWRENCE HECKER, USA
EARLY FOUNDATIONS1961 JOHN AUTIAN PLASTICS: USES AND PROBLEMS IN
PHARMACY AND MEDICINE; AM J HOSP PHARM; 18: 329 (1961)
1965 USP BIOLOGICAL TESTS FOR PLASTIC CONTAINERS
1976 ADA GUIDE TO DENTAL MATERIALS AND DEVICES;CHAPTER 14; RECOMMENDED STANDARD PRACTICES FOR BIOLOGICAL AND CLINICAL EVALUATIONS
1979 BS 5736-1 EVALUATION OF MEDICAL DEVICES FOR BIOLOGICAL HAZARDS; PART 1: GUIDE FOR THE SELECTION OF BIOLOGICAL METHODS OF TEST
1981 BS 5736-2-11 SPECIFIED TEST METHODS
1982 ASTM F748 GENERIC BIOLOGICAL TEST METHODS
1985 ISO TC-150 BIOCOMPATIBILITY TESTS (VERTICAL STANDARDS: SPECIFIC DEVICES)
1986 TRIPARTITE BIOCOMPATIBILITY GUIDANCE USA (FDA), UK (BSI), CANADA
EARLY ASTM BIOCOMPATIBILITY STANDARDS AND METHODS
• F561 1978 Retrieved Implant, Tissue, and Fluid Analysis
• F619 1979 Extraction of Medical Plastics
• F719 1981 Skin Irritation – RABBITS
• F720 1981 Contact Allergens – GUINEA PIGS
• F748 1982 Generic Biological Test Methods
• F749 1982 Intracutaneous Injection – RABBITS
• F750 1982 Systemic Extract Injection – MICE
Intravenous or Intraperitoneal
• E756 1982 Hemolysis Assay – Extract and Direct Contact
• F763 1982 Short-Term Screening of Implant Materials
Muscle Implants – 7 and 30 Days
RATS, RABBITS, OTHER ANIMALS
• F813 2001 Direct Contact Cell Culture
• F895 1984 Agar Diffusion Cell Culture
• F981 1986 Long-Term Screening of Implant Materials
Muscle and Bone Implants – 12, 26 and 52 Weeks
RATS, RABBITS AND OTHER ANIMALS
• E1262 1988 Gene Mutation Assay, Cell Culture
ASTM F748 Generic Biological Test Methods - 1982
• Cell Culture Cytotoxicity
• Sensitization
• Irritation
• Systemic Injection (Acute Toxicity)
• Blood Compatibility
• Hemolysis
• Complement Activation
• Pyrogenicity
• Short-Term Implants
• Long-Term Implants
• Genotoxicity
• Carcinogenicity (2x2x2)
• Immunotoxicity
ISO TC 194 WG 1 - TIMELINE
• 1987 WASHINGTON, D.C.• 1988 NICE, FRANCE• 1989 LONDON, U.K.• 1990 LONDON, U.K
OSLO, NORWAY (ARNE’S 50TH BIRTHDAY)BOURDEAUX, FRANCE
• ??? ZERMATT, SWITZERLAND• 1996 STOCKHOLM, SWEDEN
• 2003 (04?) TROMSO, NORWAY• 2005 UTRECHT, NETHERLANDS• 2006 CHICAGO, USA• 2015 LUND, SWITZERLAND
DRASTIC CHANGES BETWEEN 1997 AND 2006 (DIS)
• 1997 – NO “RISK ASSESSMENT” ANNEX
NORMATIVE – BIOLOGICAL EVALUATION TESTS
INFORMATIVE – ANNEX B – FLOW CHART
NO ANNEX ON “LITERATURE REVIEW”
• 2006 – RISK ASSESSMENT (MANAGEMENT) – ANNEX B
ANNEX B – ISO 14971 + OVERALL RESIDUAL RISK/BENEFIT EVALUATION - OUTLINE
NORMATIVE – FLOW CHART
INFORMATIVE – BIOLOGICAL EVALUATION TESTS
ANNEX C – LITERATURE REVIEW
ISO 10993-1• 1992 FIRST EDITION
• 1997 2ND EDITION
• 2003 3RD EDITION
• 2009 4TH EDITION
• 2018 5TH EDITION (REVISION STARTED IN 2015, LUND, SWEDEN)
ISO/DIS 10993-23
6. IN VITRO IRRITATION TESTS
6.2 IN VITRO RECONSTRUCTED HUMAN EPIDERMIS (RhE) MODEL
CELL VIABILITY – MTT TEST
CELL ACTIVITY – IL-1α ASSAY
STANDARDS ARE ALWAYS EVOLVING AND CHANGING AS NEW TECHNOLOGIES AND
ASSAYS BECOME AVAILABLE
A MAJOR GOAL IN STANDARDS DEVELOPMENT IS THE REDUCTION OF THE USE OF ANIMALS AND REPLACEMENT BY IN
VITRO METHODS
“THE ONLY CONSTANT IS CHANGE”
-WINSTON CHURCHILL
There are lies, damned lies and statistics
Facts are stubborn, but statistics are more pliable
-Mark Twain
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