| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO 5832-6:2022 |
Implants for surgery — Metallic materials — Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy |
This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-nickel chromium-molybdenum alloy for use in the manufacture of surgical implants.
NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.
|
Published |
2022-03 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-7:1984 |
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
|
Withdrawn |
1984-03 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-7:1994 |
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
Specifies the characteristics of, and corresponding test methods for, the alloys. The characteristics are chemical composition, microstructure (grain size, inclusion content), and mechanical properties.
|
Withdrawn |
1994-02 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-12:1996 |
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy |
Specifies the characteristics of, and corresponding test methods for, wrought cobalt-chromium-molybdenum alloy for use in the manufacture of surgical implants.
|
Withdrawn |
1996-06 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-7:2016 |
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
|
Published |
2016-11 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 5832-7 |
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy |
ISO 5832-7:2016 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.
|
Under development |
|
Edition : 4 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-8:1987 |
Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy |
|
Withdrawn |
1987-08 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-8:1997 |
Implants for surgery — Metallic materials — Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy |
|
Withdrawn |
1997-07 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-9:1992 |
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel |
Specifies the characteristics (chemical composition, microstructure in fully annealed condition, inclusion content, corrosion resistance, mechanical properties) of, and corresponding test methods for, wrought stainless steel containing 0,25 % and 0,5 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
|
Withdrawn |
1992-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-9:2007 |
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel |
ISO 5832-9:2007 specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
|
Withdrawn |
2007-06 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-9:2019 |
Implants for surgery — Metallic materials — Part 9: Wrought high nitrogen stainless steel |
This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
|
Published |
2019-02 |
Edition : 3 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-10:1993 |
Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy |
|
Withdrawn |
1993-09 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-10:1996 |
Implants for surgery — Metallic materials — Part 10: Wrought titanium 5-aluminium 2,5-iron alloy |
|
Withdrawn |
1996-06 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-11:1994 |
Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
Gives the characteristics of and corresonding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (titanium 6-Al 7-Nb) for use in the manufacture of surgical implants.
|
Withdrawn |
1994-09 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-11:2014 |
Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
ISO 5832-11:2014 specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6-Al 7-Nb) for use in the manufacture of surgical implants.
|
Published |
2014-09 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 5832-11 |
Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
|
Under development |
|
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 3107:1974 |
Dental zinc oxide/eugenol cementing materials |
|
Withdrawn |
1974-10 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.060.10
Dental materials
|
| ISO 5832-12:2007 |
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy |
ISO 5832-12:2007 covers the requirements for two wrought cobalt 28 chromium 6 molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire.
|
Withdrawn |
2007-05 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-12:2007/Cor 1:2008 |
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy — Technical Corrigendum 1 |
|
Withdrawn |
2008-09 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-12:2019 |
Implants for surgery — Metallic materials — Part 12: Wrought cobalt-chromium-molybdenum alloy |
This document specifies the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the final device is not included as part of this document.
|
Published |
2019-02 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-14:2007 |
Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy |
ISO 5832-14:2007 specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants.
ISO 5832-14:2007 applies to materials in bar form up to a maximum diameter of 100 mm.
|
Withdrawn |
2007-10 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5832-14:2019 |
Implants for surgery — Metallic materials — Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy |
This document specifies the characteristics of, and corresponding test methods for, the wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloy for use in the manufacture of surgical implants.
This document applies to materials in bar form up to a maximum diameter of 100 mm.
NOTE The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
|
Published |
2019-02 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5833-1:1979 |
Implants for surgery — Acrylic resin cements — Part 1: Orthopaedic applications |
|
Withdrawn |
1979-06 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5833:1992 |
Implants for surgery — Acrylic resin cements |
Applies to radio-opaque and non-radio-opaque self-curing resin cements on polymethacrylic acid esters and specifies physical, mechanical, packaging and labelling requirements and appropriate test methods. All requirements apply to, and all tests are to be performed on, the sterile product.
|
Withdrawn |
1992-11 |
Edition : 1 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5833:2002 |
Implants for surgery — Acrylic resin cements |
This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.
This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.
All requirements apply to, and all tests are intended to be performed on, the sterile product.
|
Published |
2002-05 |
Edition : 2 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-1:1985 |
Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form |
|
Withdrawn |
1985-07 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-1:1998 |
Implants for surgery — Ultra-high molecular weight polyethylene — Part 1: Powder form |
|
Withdrawn |
1998-08 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-1:2005 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form |
ISO 5834-1:2005 specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
It is not applicable to finished products.
|
Withdrawn |
2005-06 |
Edition : 3 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-1:2019 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form |
This document specifies the requirements and corresponding test methods for moulding materials in powder form made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
It is not applicable to finished products.
|
Published |
2019-02 |
Edition : 4 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-2:1985 |
Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms |
|
Withdrawn |
1985-07 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-2:1998 |
Implants for surgery — Ultra-high molecular weight polyethylene — Part 2: Moulded forms |
|
Withdrawn |
1998-08 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-2:2006 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms |
ISO 5834-2:2006 specifies the requirements and corresponding test methods for moulded forms (sheets, rods) made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
|
Withdrawn |
2006-04 |
Edition : 3 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-2:2011 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms |
ISO 5834-2:2011 specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
ISO 5834-2:2011 is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or from blending of different forms of polyethylene.
|
Withdrawn |
2011-08 |
Edition : 4 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-2:2019 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms |
This document specifies the requirements and corresponding test methods for moulded forms, e.g. sheets and rods, made from ultra-high-molecular-weight polyethylene (UHMWPE) for use in the manufacture of surgical implants.
This document is not applicable to direct-moulded (near net shape), irradiated or finished products or products manufactured from polyethylene blended with additives or by blending different forms of polyethylene.
|
Published |
2019-02 |
Edition : 5 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-3:2005 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods |
ISO 5834-3:2005 specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. ISO 5834-3:2005 describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.
|
Withdrawn |
2005-07 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-3:2019 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 3: Accelerated ageing methods |
This document specifies a test method for investigating the oxidative stability of ultra-high-molecular-weight polyethylene (UHMWPE) materials as a function of processing and sterilization method. This document describes a laboratory method for accelerated ageing of UHMWPE specimens and components for total joint prostheses. The UHMWPE is aged at elevated temperature and at elevated oxygen pressure, to accelerate oxidation of the material and thereby allow for the evaluation of its potential long-term chemical and mechanical stability.
|
Published |
2019-02 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-4:2005 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method |
ISO 5834-4:2005 specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE).
ISO 5834-4:2005 is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants.
|
Withdrawn |
2005-05 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-4:2019 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Oxidation index measurement method |
This document specifies a method for the measurement of the relative extent of oxidation present in ultra-high molecular weight polyethylene (UHMWPE).
It is applicable to ultra-high molecular weight polyethylene (UHMWPE) intended for use in surgical implants.
|
Published |
2019-02 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 4000-1:2001/Amd 1:2004 |
Passenger car tyres and rims — Part 1: Tyres (metric series) — Amendment 1 |
|
Withdrawn |
2004-05 |
Edition : 7 |
Number of pages : 6 |
Technical Committee |
83.160.10
Road vehicle tyres
|
| ISO 5834-5:2005 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method |
ISO 5834-5:2005 specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834-2.
It is not applicable to UHMWPE powder forms, which are described in ISO 5834-1.
|
Withdrawn |
2005-06 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5834-5:2019 |
Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 5: Morphology assessment method |
This document specifies the test method for assessing the morphology of UHMWPE moulded forms, which are described in ISO 5834‑2.
It is not applicable to UHMWPE powder forms, which are described in ISO 5834‑1.
NOTE Performance requirements for this test method have not been established.
|
Published |
2019-02 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5835-1:1985 |
Implants for surgery — Metal bone screws — Dimensions — Part 1: Screws with asymmetrical thread, spherical under-surfaces |
|
Withdrawn |
1985-06 |
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5835-2:1978 |
Implants for surgery — Metal bone screws — Dimensions — Part 2: Screws with asymmetrical thread, constant fitting (spherical) |
|
Withdrawn |
1978-03 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5835-4:1983 |
Implants for surgery — Metal bone screws — Dimensions — Part 4: Screws with symmetrical thread, conical under-surfaces |
|
Withdrawn |
1983-07 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5835:1991 |
Implants for surgery — Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread — Dimensions |
Gives dimensions and tolerances and the code for screw thread. Screws with shallow thread shall be as given in figures 1 and 2 and tables 1 and 2. Screws with deep thread shall be as given in figures 3 and 4 and tables 3 and 4. Marking and packaging shall be in accordance with ISO 6018. An example for combined screw is given in annex A. An interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is given in annex B. Bibliography is given in annex C.
|
Published |
1991-01 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5836-4:1984 |
Implants for surgery — Metal bone plates — Part 4: Holes and slots corresponding to screws with symmetrical thread and conical under-surfaces |
|
Withdrawn |
1984-07 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5836:1988 |
Implants for surgery — Metal bone plates — Holes corresponding to screws with asymmetrical thread and spherical under-surface |
Specification of the dimensions and tolerances of holes in bone plates so as to facilitate correct fixing using screws complying with ISO 5835. It does not deal with the shape and dimensions of the plates or with the spacing of the holes. Annex A shows a bibliography of the International Standards dealing with bone srews, bone plates and relevant tools for information.
|
Published |
1988-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5837-1:1985 |
Implants for surgery — Intramedullary nailing systems — Part 1: Intramedullary nails with cloverleaf or V-shaped cross-section |
Specifies the main and fitting dimensions for intramedullary nails of the cross-section mentioned. It also specifies extracting hooks and recommends the diameters of the guide wires to be used with the nails.
|
Published |
1985-06 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5837-2:1980 |
Implants for surgery — Intramedullary nailing systems — Part 2: Medullary pins |
Specification of material, method of manufacture, surface finish, main dimensions and requirements for medullary pins used in the bone surgery.
|
Withdrawn |
1980-11 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5838-1:1983 |
Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements |
|
Withdrawn |
1983-08 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5838-1:1995 |
Implants for surgery — Skeletal pins and wires — Part 1: Material and mechanical requirements |
Specifies materials and mechanical requirements for skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting. Replaces the first edition, of which it constitutes a technical revision.
|
Withdrawn |
1995-11 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5838-1:2013 |
Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements |
This part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting.
|
Published |
2013-03 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 5838-1 |
Implants for surgery — Metallic skeletal pins and wires — Part 1: General requirements |
|
Deleted |
|
Edition : 4 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5838-2:1991 |
Implants for surgery — Skeletal pins and wires — Part 2: Steinmann skeletal pins — Dimensions |
Specifies the dimensions. Material and mechanical requirements are covered by ISO 5838-1. Dimensions shall be according to figure 1 to figure 5 and table 1 to table 3. The ends, form A - plain, form B - square and form C - triangular, shall comply with the figures 3 to 5 and tables 2 and 3.
|
Published |
1991-01 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5838-3:1993 |
Implants for surgery — Skeletal pins and wires — Part 3: Kirschner skeletal wires |
Specifies the characteristics (dimensions, ends, marking and packaging) of Kirschner wires. Material and mechanical requirements are covered by ISO 5838-1.
|
Published |
1993-09 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5839:1985 |
Implants for surgery — Orthopaedic joint prostheses — Basic requirements |
|
Withdrawn |
1985-06 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-1:2015 |
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements |
ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840?series provide specific requirements.
ISO 5840-1:2015 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1:2015 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1:2015 defines operational conditions for heart valve substitutes.
ISO 5840-1:2015 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
|
Withdrawn |
2015-09 |
Edition : 1 |
Number of pages : 56 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-1:2021 |
Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements |
This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-1 defines operational conditions for heart valve substitutes.
ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3.
ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable.
NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A.
|
Published |
2021-01 |
Edition : 2 |
Number of pages : 79 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-2:2015 |
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes |
ISO 5840-2:2015 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization.
ISO 5840-2:2015 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
ISO 5840-2:2015 outlines an approach for qualifying the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
ISO 5840-2:2015 defines performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840‑3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.
ISO 5840-2:2015 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
ISO 5840-2:2015 excludes homografts.
|
Withdrawn |
2015-09 |
Edition : 1 |
Number of pages : 55 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-2:2021 |
Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes |
This document is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.
This document is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a surgical heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.
This document defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
For some heart valve substitutes (e.g. sutureless), the requirements of both this document and ISO 5840-3:2021 can be relevant and are considered as applicable to the specific device design and are based on the results of the risk analysis.
|
Published |
2021-01 |
Edition : 2 |
Number of pages : 51 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-3:2013 |
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques |
ISO 5840-3:2013 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840-3:2013 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
ISO 5840-3:2013 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.
ISO 5840-3:2013 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
|
Withdrawn |
2013-03 |
Edition : 1 |
Number of pages : 105 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840-3:2021 |
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques |
This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
|
Published |
2021-01 |
Edition : 2 |
Number of pages : 57 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840:1984 |
Implants for surgery — Cardiovascular implants — Cardiac valve prostheses |
|
Withdrawn |
1984-09 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840:1989 |
Cardiovascular implants — Cardiac valve prostheses |
|
Withdrawn |
1989-11 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840:1996 |
Cardiovascular implants — Cardiac valve prostheses |
Tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve implantates of all types, and of the materials and components of which they are made. Requirements are provided for preclinical, clinical evaluation and for reporting the results.
|
Withdrawn |
1996-11 |
Edition : 3 |
Number of pages : 38 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5840:2005 |
Cardiovascular implants — Cardiac valve prostheses |
ISO 5840:2005 is applicable to all devices intended for implantation in human hearts, as a heart valve substitute.
It is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
ISO 5840:2005 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
ISO 5840:2005 imposes design specifications and minimum performance specifications for heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
It excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices.
|
Withdrawn |
2005-03 |
Edition : 4 |
Number of pages : 84 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-1:1989 |
Cardiac pacemakers — Part 1: Implantable pacemakers |
This standard is valid for all types of implantable pacemakers and specifies as well the basic terms and definitions as the requirements for designation and packaging of pacemakers. In connection with the corresponding test methods minimum requirements are given for the ability of a pacemaker generator to resist adverse environmental conditions. The annexes A to F contain a code system for identification of the mode of operation, test methods, evaluation of livetime, certain forms and the symbols that can be be used instead of written words.
|
Withdrawn |
1989-11 |
Edition : 2 |
Number of pages : 25 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-2:1986 |
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of the clinical performance of populations of pulse generators |
|
Withdrawn |
1986-11 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-2:2000 |
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads |
|
Withdrawn |
2000-10 |
Edition : 2 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-2:2014 |
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads |
ISO 5841-2:2014 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long-term implantation, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.
|
Published |
2014-08 |
Edition : 3 |
Number of pages : 26 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-3:1992 |
Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
|
Withdrawn |
1992-11 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-3:2000 |
Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
|
Withdrawn |
2000-10 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-3:2000/Cor 1:2003 |
Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers — Technical Corrigendum 1 |
|
Withdrawn |
2003-11 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5841-3:2013 |
Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers |
ISO 5841-3:2013 specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pacemaker pulse generators. Essential dimensions and performance requirements related to connector fit are specified, together with appropriate test methods.
ISO 5841-3:2013 is applicable only to the form and fit of the connector assembly.
ISO 5841-3:2013 supplements ISO 14708‑2 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part.
|
Published |
2013-04 |
Edition : 3 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5910:2018 |
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
1.1 This document applies to all heart valve repair systems that have an intended use to repair and/or improve the function of native human heart valves by acting either on the valve apparatus or on the adjacent anatomy (e.g. ventricle, coronary sinus).
1.2 This document outlines an approach for verifying/validating the design and manufacture of a heart valve repair system through risk management. The selection of appropriate verification/validation tests and methods are derived from the risk assessment. The tests include assessments of the physical, chemical, biological, and mechanical properties of components and materials of heart valve repair systems. The tests also include preclinical in vivo evaluation and clinical investigation of the finished heart valve repair system to assess the safety and effectiveness of the heart valve repair system.
NOTE For the purposes of this document, effectiveness endpoint includes clinical performance and benefits.
1.3 This document defines operational conditions and performance requirements for heart valve repair systems where adequate scientific and/or clinical evidence exists for their justification.
1.4 This document excludes Cardiac Resynchronization Therapy (CRT) devices, paravalvular leakage closure devices, systems that do not leave an implant in place (e.g. ablation, radio frequency annuloplasty), apical conduits and devices with components containing viable cells. This Standard also excludes materials not intended for repairing and/or improving the function of human heart valves according to its intended use (e.g. patch material and sutures used in general surgical practice).
NOTE A rationale for the provisions of this document is given in Annex A.
|
Published |
2018-06 |
Edition : 1 |
Number of pages : 126 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 5910 |
Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices |
|
Under development |
|
Edition : 2 |
Number of pages : 101 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6018:1987 |
Orthopaedic implants — General requirements for marking, packaging and labelling |
|
Withdrawn |
1987-10 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 5139 |
Dentistry — Polymer-based composite machinable blanks |
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.060.10
Dental materials
|
| ISO 6474-1:2010 |
Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina |
ISO 6474-1:2010 specifies the characteristics of, and corresponding test methods for, a bio-compatible and bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses.
|
Withdrawn |
2010-02 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6474-1:2019 |
Implants for surgery — Ceramic materials — Part 1: Ceramic materials based on high purity alumina |
This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic bone substitute material based on high purity alumina for use as bone spacers, bone replacements and components of orthopaedic joint prostheses.
This document does not cover biocompatibility (see ISO 10993-1). It is the responsibility of the manufacturer to evaluate the biocompatibility of ceramic materials which are produced within the framework of this document.
|
Published |
2019-03 |
Edition : 2 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6474-2:2012 |
Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
|
Withdrawn |
2012-04 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6474-2:2019 |
Implants for surgery — Ceramic materials — Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement |
This document specifies the characteristics of, and corresponding test methods for bio-stable ceramic-bone-substitute material based on a zirconia-reinforced, high-purity alumina matrix composite for use as bone spacers, bone replacements and components in orthopaedic joint prostheses.
This document is intended for composite materials which are based on an alumina matrix, i.e. alumina as the dominating phase in the composite with a mass fraction of >60 %, similar to the material described in ISO 6474‑1, but extended by means of a certain amount of zirconia and other defined ingredients.
NOTE The required properties in this document differ from those in ISO 6474‑1 with respect to strength and fracture toughness. Furthermore, there are requirements specifically applicable for zirconia-containing materials (see ISO 13356).
In the material composition as defined in this document, additional additives are listed. Typical additives for alumina or zirconia ceramics are Mg, Y, Ce and others. Such additives can be useful in order to improve the mechanical properties and/or the chemical stability of the alumina-zirconia composite material.
This document does not cover biocompatibility (see ISO 10993‑1). It is the responsibility of the manufacturer to evaluate the biocompatibility of the specific ceramic composite material which is produced within the framework of this document.
|
Published |
2019-03 |
Edition : 2 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6474:1981 |
Implants for surgery — Ceramic materials based on alumina |
|
Withdrawn |
1981-02 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6474:1994 |
Implants for surgery — Ceramic materials based on high purity alumina |
Specification of characteristics and corresponding test methods for biocompatible and bio-stable ceramic bone substitutes based on high purity alumina.
|
Withdrawn |
1994-02 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6475-1:1980 |
Implants for surgery — Metal bone screws — Mechanical requirements and methods of test — Part 1: Screws with asymmetrical thread, variable fitting (spherical), stainless steel |
|
Withdrawn |
1980-10 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6475-2:1980 |
Implants for surgery — Metal bone screws — Mechanical requirements and methods of test — Part 2: Screws with asymmetrical thread, constant fitting (spherical), stainless steel |
|
Withdrawn |
1980-10 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6475:1989 |
Implants for surgery — Metal bone screws with asymmetrical thread and spherical under-surface — Mechanical requirements and test methods |
This standard does not relate to all safety problems concerned with application. It bases on the dimensions of bone screws given in ISO 5835 and ISO 5832-1. The results obtained does not have a direct correlation to the application of screws. Annex A is normative and contains mechanical requirements to bone screws made from stainless steel. The informative Annexes B and C show the intercorrelations of international standards for bone screws, plates and the corresponding tools and a bibliography.
|
Published |
1989-11 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/PAS 7020 |
Size designation of surgical valve prostheses: Requirements regarding the application of ISO 5840-2 |
|
Under development |
|
Edition : 1 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7197:1989 |
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7197:2006 |
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components |
ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.
For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.
The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.
|
Published |
2006-06 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7197:2006/Cor 1:2007 |
Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components — Technical Corrigendum 1 |
|
Published |
2007-07 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 7197 |
Neurosurgical implants — Sterile, single-use hydrocephalus shunts |
ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.
For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.
The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.
|
Under development |
|
Edition : 4 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7198:1998 |
Cardiovascular implants — Tubular vascular prostheses |
|
Withdrawn |
1998-07 |
Edition : 1 |
Number of pages : 48 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7198:2016 |
Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches |
ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE Requirements for vascular stents are specified in ISO 25539‑2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:2016 can be a useful guide for certain testing requirements for these cell-based products.
Pharmacological aspects of drug-eluting or drug-coated vascular prostheses are not addressed in ISO 7198:2016.
NOTE Requirements for vascular device-drug combination products are specified in ISO 12417-1.
Degradation, tissue ingrowth and/or tissue replacement, and other time-dependent aspects of absorbable vascular prostheses are not addressed in ISO 7198:2016.
|
Published |
2016-08 |
Edition : 2 |
Number of pages : 54 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7199:1996 |
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
Requirements for sterile, single-use, extracorporeale blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7199:2009 |
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
ISO 7199:2009 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.
|
Withdrawn |
2009-04 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7199:2009/Amd 1:2012 |
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Clarifications for test methodologies, labelling, and sampling schedule |
|
Withdrawn |
2012-02 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7199:2016 |
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) |
ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans.
ISO 7199:2016 also applies to heat exchangers and arterial filters that are integral parts of the oxygenator.
ISO 7199:2016 also applies to external equipment unique to the use of the oxygenator.
ISO 7199:2016 does not apply to
- implanted oxygenators,
- liquid oxygenators,
- extracorporeal circuits (blood tubing),
- separate heat exchangers,
- separate ancillary devices, and
- separate arterial line filter.
|
Published |
2016-11 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7199:2016/Amd 1:2020 |
Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) — Amendment 1: Connectors |
|
Published |
2020-03 |
Edition : 3 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 12215-8:2009/Cor 1:2010 |
Small craft — Hull construction and scantlings — Part 8: Rudders — Technical Corrigendum 1 |
|
Published |
2010-09 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
47.080
Small craft
|