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  • ISO 5832-1:2016

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  02-04-2024

    Language(s):  French, English

    Published date:  11-07-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 5832-1:2016 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

    NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

    NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 150/SC 1
    Development Note Supersedes ISO/DIS 5832-1. (07/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    13/30261812 DC : 0 BS ISO 10555-6 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
    DIN EN ISO 13017:2016-05 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
    03/100426 DC : DRAFT JAN 2003 BS EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    I.S. EN ISO 10555-6:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Physico-chemical, morphological and topographical characterization of materials
    ASTM F 2068 : 2015 : REDLINE Standard Specification for Femoral Prostheses—Metallic Implants
    I.S. EN ISO 16061:2015 INSTRUMENTATION FOR USE IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 16061:2015)
    DIN EN ISO 10555-6:2017-11 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    ASTM F 2181 : 2014 : REDLINE Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants
    ISO 15374:1998 Implants for surgery — Requirements for production of forgings
    11/30242625 DC : 0 BS ISO 5838-1 - IMPLANTS FOR SURGERY - METALLIC SKELETAL PINS AND WIRES - PART 1: GENERAL REQUIREMENTS
    17/30302773 DC : 0 BS ISO 13779-4 - IMPLANTS FOR SURGERY - HYDROXYAPATITE - PART 4: DETERMINATION OF COATING ADHESION STRENGTH
    UNE-EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    BS ISO 5838-1:2013 Implants for surgery. Metallic skeletal pins and wires General requirements
    BS ISO 15374:1998 Implants for surgery. Requirements for production of forgings
    BS ISO 12891-2:2014 Retrieval and analysis of surgical implants Analysis of retrieved surgical implants
    ISO 5838-1:2013 Implants for surgery Metallic skeletal pins and wires Part 1: General requirements
    AAMI BE83 : 2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    BS EN ISO 13017 : 2012 DENTISTRY - MAGNETIC ATTACHMENTS
    ISO 12891-2:2014 Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implants
    DIN EN ISO 10993-18:2009-08 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
    BS EN ISO 10993-6:2016 Biological evaluation of medical devices Tests for local effects after implantation
    BS EN 12010:1998 Non-active surgical implants. Joint replacement implants. Particular requirements
    I.S. EN ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    UNI EN ISO 10993-18 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    DIN EN ISO 16061:2015-09 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    DIN EN ISO 10555-6 E : 2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS (ISO 10555-6:2015)
    11/30197571 DC : 0 BS ISO 25832-1 - IMPLANTS FOR SURGERY - SEAMLESS TUBES FOR SURGICAL IMPLANTS - PART 1: MATERIALS BASED ON IRON
    BS ISO 10555-6 : 2015 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 6: SUBCUTANEOUS IMPLANTED PORTS
    EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports (ISO 10555-6:2015)
    ANSI/AAMI/ISO TIR10993-19:2006 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICOCHEMICAL, MORPHOLOGICAL, AND TOPOGRAPHICAL CHARACTERIZATION OF MATERIALS
    ISO 10334:1994 Implants for surgery — Malleable wires for use as sutures and other surgical applications
    ASTM F 139 : 2012 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
    ANSI/AAMI/ISO 10993-6:2016 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    BS EN ISO 10555-6:2017 Intravascular catheters. Sterile and single-use catheters Subcutaneous implanted ports
    ASTM F 2257 : 2014 : REDLINE Standard Specification for Wrought Seamless or Welded and Drawn 18 Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673)
    ISO 10555-6:2015 Intravascular catheters Sterile and single-use catheters Part 6: Subcutaneous implanted ports
    BS EN ISO 10993-18:2009 Biological evaluation of medical devices Chemical characterization of materials
    I.S. EN ISO 10993-18:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005)
    EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
    EN ISO 13017:2012/A1:2015 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012/AMD 1:2015)
    14/30261590 DC : 0 BS EN ISO 10993-6 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    ISO 5837-1:1985 Implants for surgery Intramedullary nailing systems Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section
    13/30242622 DC : 0 BS ISO 12891-2 - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 2: ANALYSIS OF RETRIEVED SURGICAL IMPLANTS
    I.S. EN ISO 13017:2012 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012)
    CSA ISO 10993-6 : 1997(R2009) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
    ISO 5837-2:1980 Implants for surgery Intramedullary nailing systems Part 2: Medullary pins
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    ISO 16061:2015 Instrumentation for use in association with non-active surgical implants General requirements
    UNE-EN ISO 13017:2013 Dentistry - Magnetic attachments (ISO 13017:2012)
    BS EN 30993-6:1995 Biological evaluation of medical devices Tests for local effects after implantation
    ISO 13017:2012 Dentistry Magnetic attachments
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    BS EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants. General requirements
    ANSI/AAMI BE83:2006(R2011) BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    NFS 94 090 : 2005 MEDICO-SURGICAL EQUIPMENT - MATERIALS FOR ANCILLARY POSITIONING INSTRUMENTS FOR BONE SURGERY - MARTENSITIC, PRECIPITATION HARDENING, AUSTENITIC AND AUSTENO-FERRITIC STAINLESS STEELS
    ASTM F 621 : 2012 : R2017 Standard Specification for Stainless Steel Forgings for Surgical Implants
    ASTM F 621 : 2012 Standard Specification for Stainless Steel Forgings for Surgical Implants
    DIN EN ISO 10993-18 E : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
    DIN EN ISO 10993-6:2009-08 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
    DIN EN ISO 10993-6:2017-09 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)

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

    ISO 404:2013 Steel and steel products — General technical delivery requirements
    ISO 671:1982 Steel and cast iron Determination of sulphur content Combustion titrimetric method
    ASTM F 139 : 2012 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)
    ISO 4967:2013 Steel — Determination of content of non-metallic inclusions — Micrographic method using standard diagrams
    ISO 6892-1:2016 Metallic materials Tensile testing Part 1: Method of test at room temperature
    ISO 629:1982 Steel and cast iron — Determination of manganese content — Spectrophotometric method
    DIN 17443:1986-04 ROLLED AND WROUGHT STAINLESS STEEL PRODUCTS FOR SURGICAL IMPLANTS - TECHNICAL DELIVERY CONDITIONS
    ISO 439:1994 Steel and iron Determination of total silicon content Gravimetric method
    ISO 10714:1992 Steel and iron — Determination of phosphorus content — Phosphovanadomolybdate spectrophotometric method
    ISO 643:2012 Steels Micrographic determination of the apparent grain size
    ISO 377:2017 Steel and steel products — Location and preparation of samples and test pieces for mechanical testing
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