ISO 5832-1:2016
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
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Superseded date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
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part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
| Committee |
ISO/TC 150/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 5832-1. (07/2016)
|
| DocumentType |
Standard
|
| Pages |
6
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DS/EN ISO 5832-1:2019 | Identical |
| BS EN ISO 5832-1:2019 | Identical |
| I.S. EN ISO 5832-1:2019 | Identical |
| ÖNORM EN ISO 5832-1: 2019 | Identical |
| NF ISO 5832-1 : 2016 | Identical |
| SS-EN ISO 5832-1:2019 | Identical |
| BS ISO 5832-1:2007 | Identical |
| SN EN ISO 5832-1:2020 | Identical |
| NF EN ISO 5832-1:2019 | Identical |
| NEN-EN-ISO 5832-1:2019 | Identical |
| EN ISO 5832-1:2019 | Identical |
| NS-EN ISO 5832-1:2019 | Identical |
| UNI EN ISO 5832-1:2020 | Identical |
| PN-EN ISO 5832-1:2020-03 | Identical |
| DS ISO 5832-1 : 2016 | Identical |
| UNE-EN ISO 5832-1:2020 | Identical |
| NFS 90 401 : LATEST | Identical |
| UNE 18053:1978 | Identical |
| BS 3531-2:1980 | Similar to |
| DIN ISO 5832-1:2008-12 | Identical |
| UNI 9763-1 : 1990 | Similar to |
| BS ISO 5832-1:2016 | Identical |
| UNE 91110:1990 | Identical |
| BS 7252-1:1990 | Identical |
| GOST R ISO 5832-1 : 2010 | Identical |
| SNV ISO 5832-1 : 1997 | Identical |
| 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) |
| 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) |
| 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 10993-6:2009-08 | 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) |
| 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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