| Name |
Description |
Abstract |
Status |
Publication date |
Edition |
Number of pages |
Technical committee |
ICS |
| ISO/CD 7199 |
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.
|
Under development |
|
Edition : 4 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-1:1985 |
Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification, designation of dimensions and requirements |
|
Withdrawn |
1985-08 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-1:1995 |
Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
Specifies the means of classification and defines the designation of dimensions for partial and total hip joint prostheses. Classified as femoral prostheses and acetabular prostheses.
|
Withdrawn |
1995-08 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-1:2008 |
Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions |
ISO 7206-1:2008 provides a means of classification and standardizes the designation of dimensions for partial and total hip joint prostheses.
|
Published |
2008-04 |
Edition : 3 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-2:1987 |
Implants for surgery — Partial and total hip joint prostheses — Part 2: Bearing surfaces made of metallic and plastics materials |
|
Withdrawn |
1987-04 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-2:1996 |
Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
Specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, e.g. sphericity and surface finish for metallic and ceramic femoral prostheses, sphericity, surface finish and dimensional tolerances for plastics acetabular components. Replaces the first edition.
|
Withdrawn |
1996-05 |
Edition : 2 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-2:2011 |
Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials |
ISO 7206-2:2011 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows:
sphericity and surface finish requirements for metallic and ceramic femoral prostheses for partial hip joint replacement that are in accordance with classification a) of ISO 7206-1;
sphericity and surface finish requirements for bipolar heads with plastics inner surfaces which articulate on femoral components that are in accordance with classification a) of ISO 7206-1 and with metallic or ceramic outer surfaces which articulate on the biological acetabulum;
sphericity and surface finish requirements and dimensional tolerances for plastics acetabular components that are in accordance with classification b) of ISO 7206-1;
sphericity and surface finish requirements and dimensional tolerances for metallic or ceramic femoral components of total hip joint prostheses that are in accordance with classification c) of ISO 7206-1, designed to articulate on plastics acetabular components.
|
Published |
2011-04 |
Edition : 3 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-2:2011/Amd 1:2016 |
Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials — Amendment 1 |
|
Published |
2016-09 |
Edition : 3 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-3:1988 |
Implants for surgery — Partial and total hip joint prostheses — Part 3: Determination of endurance properties of stemmed femoral components without application of torsion |
|
Withdrawn |
1988-07 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-4:1989 |
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components with application of torsion |
This standard defines a test method and laboratory conditions so that the important parameters that affect the components are taken into account and describes how the specimen is set up for testing. The test method has been developed for prostheses that have a plane of symmetry and may not be suitable for other designs. The standard does not cover methods of examining and reporting of the test specimen. The informative Annex A includes a guidance on composition of high-alumina cement embedding medium.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-4:2002 |
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components |
This part of ISO 7206 specifies a test method for determining the endurance properties, under specified laboratory conditions, of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints. It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing.
This part of ISO 7206 is applicable to prostheses that have a plane of symmetry, or have preformed anteversion or double curvature of the stem, and to prostheses designed for use in revision surgery.
This part of ISO 7206 does not specify methods of examining the test specimen; these should be agreed between the test laboratory and the party submitting the specimen for test.
|
Withdrawn |
2002-10 |
Edition : 2 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-4:2010 |
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components |
ISO 7206‑4:2010 specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing.
Furthermore, ISO 7206‑4:2010 specifies the test parameters and the requirements for the endurance limit of stemmed femoral components tested in accordance with this document. The value of the endurance limit test forces and the corresponding number of load cycles are specified.
|
Published |
2010-06 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-4:2010/Amd 1:2016 |
Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components — Amendment 1 |
|
Published |
2016-03 |
Edition : 3 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-5:1992 |
Implants for surgery — Partial and total hip joint prostheses — Part 5: Determination of resistance to static load of head and neck region of stemmed femoral components |
|
Withdrawn |
1992-03 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-6:1992 |
Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
Describes test methods for determining the endurance properties under specified laboratory conditions. Specifies the principle, the reagents and materials, the apparatus, the procedure, the test report and the disposal of test specimens.
|
Withdrawn |
1992-03 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-6:2013 |
Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components |
ISO 7206-6:2013 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of the neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. It is applicable to modular and non-modular designs made of metallic or non-metallic materials.
It also specifies the test conditions so that the important parameters that affect the hip femoral components are taken into account and describes how the specimen is set up for testing.
|
Published |
2013-11 |
Edition : 2 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-7:1993 |
Implants for surgery — Partial and total hip joint prostheses — Part 7: Endurance performance of stemmed femoral components without application of torsion |
|
Withdrawn |
1993-05 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-8:1995 |
Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion |
Specifies the endurance performance of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacements as determined under specified laboratory conditions by a method that includes the application of torsion. Does not apply to prostheses for special clinical cases; prostheses for which the centreline of the stem is three-dimensionally curved and does not lie in any plane in which the axis of the neck lies.
|
Withdrawn |
1995-04 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-9:1994 |
Implants for surgery — Partial and total hip joint prostheses — Part 9: Determination of resistance to torque of head fixation of stemmed femoral components |
|
Withdrawn |
1994-12 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6247:1998/Cor 1:1999 |
Petroleum products — Determination of foaming characteristics of lubricating oils — Technical Corrigendum 1 |
|
Published |
1999-09 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
75.100
Lubricants, industrial oils and related products
|
| ISO 7206-10:2003 |
Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads |
ISO 7206-10:2003 applies to femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection) and describes methods of determining the load required, under specified laboratory conditions, to cause failure of the head (disassembly or fracture). It applies to components made of metallic and non-metallic materials.
ISO 7206-10:2003 does not cover methods of examining and reporting the test specimens.
|
Withdrawn |
2003-12 |
Edition : 1 |
Number of pages : 10 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-10:2018 |
Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads |
This document specifies methods of determining the compressive (fracture) or the tension (disassembly) loads required, under specific laboratory conditions, to cause failure of a modular head system.
This document applies to components made of metallic and non-metallic materials, such as femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection).
This document excludes methods of examining and reporting the test specimens.
|
Published |
2018-08 |
Edition : 2 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-10:2018/Amd 1:2021 |
Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads — Amendment 1 |
|
Published |
2021-05 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-12:2016 |
Implants for surgery — Partial and total hip joint prostheses — Part 12: Deformation test method for acetabular shells |
ISO 7206-12:2016 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part of ISO 7206 specifies the test parameters of press-fit acetabular components tested in accordance with this part of ISO 7206.
The described method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions.
The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance.
ISO 7206-12:2016 does not cover methods of examining the test specimen.
|
Published |
2016-10 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-13:2016 |
Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components |
ISO 7206-13:2016 describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the head of hip joint prostheses in which the head is not intended to rotate relative to the neck. It applies to the femoral component of total or partial hip joint replacements in which the head and neck/stem (in the following referred to as cone) are secured together by a locking conical taper or any other means and in which the head and cone are separate components, and which are made of metallic or non-metallic materials.
It does not cover methods of examining the test specimens; these should be agreed between the test laboratory and the party submitting the specimen for test.
|
Published |
2016-07 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7206-13:2016/Amd 1:2022 |
Implants for surgery — Partial and total hip joint prostheses — Part 13: Determination of resistance to torque of head fixation of stemmed femoral components — Amendment 1 |
|
Published |
2022-05 |
Edition : 1 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-1:1985 |
Implants for surgery — Partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions |
|
Withdrawn |
1985-09 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-1:1994 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions |
Cancels and replaces the first edition (1985). Classifies femoral and tibial components for knee joint protheses in which one or both bearing surfaces of at least one compartment of the knee are replaced, and gives definitions of components and the designation of dimensions.
|
Withdrawn |
1994-10 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-1:2007 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 1: Classification, definitions and designation of dimensions |
ISO 7207-1:2007 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives definitions of components and the designation of dimensions.
|
Published |
2007-02 |
Edition : 3 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-2:1998 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
|
Withdrawn |
1998-07 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-2:2011 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials |
ISO 7207-2:2011 specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1.
ISO 7207-2:2011 is intended to provide guidance for periodic validation of production processes.
|
Published |
2011-07 |
Edition : 2 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-2:2011/Amd 1:2016 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials — Amendment 1 |
|
Published |
2016-08 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 7207-2:2011/Amd 2:2020 |
Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials — Amendment 2 |
|
Published |
2020-06 |
Edition : 2 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8319-1:1986 |
Orthopaedic instruments — Drive connections — Part 1: Keys for use with screws with hexagon socket heads |
|
Withdrawn |
1986-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8319-1:1996 |
Orthopaedic instruments — Drive connections — Part 1: Keys for use with screws with hexagon socket heads |
Specifies the dimensions, tolerances, mechanical properties and performance requirements of the working end of keys to be used for metal bone screws with hexagon drive sockets, used as surgical implants.
|
Published |
1996-05 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8319-2:1986 |
Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws |
The purpose is to ensure that the essential requirements of all screw keys are achieved without imposing undue restriction on design features. This standard specifies the requirements for screwdrivers used in orthopaedic surgery for inserting and removing bone screws. Screw keys with the working end specified are suitable for use with screws which conform to ISO 9268.
|
Published |
1986-10 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-1:1989 |
Prosthetics and orthotics — Limb deficiencies — Part 1: Method of describing limb deficiencies present at birth |
This method includes only bone deficiencies due to the failure of the formation ability of segments. It bases on anatomic and radiologic statements while ethiologic and epidemiologic factors are excluded. An example for the description of longitudinal deficiencies is given in the annex.
|
Published |
1989-08 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-2:1993 |
Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps |
Establishes a method of describing lower limb amputation stumps and proposes a standardized system for recording the descriptive information which can be easily incorporated in reports and forms and should also be capable of ready adaptation for computer analysis. Deliberately aims at defining the minimum information to be described.
|
Withdrawn |
1993-06 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-2:2020 |
Prosthetics and orthotics — Limb deficiencies — Part 2: Method of describing lower limb amputation stumps |
This document establishes a method of describing and measuring lower limb amputation stumps. It also lists the measurements required for the provision of a prosthesis.
|
Published |
2020-04 |
Edition : 2 |
Number of pages : 19 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-3:1993 |
Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing upper limb amputation stumps |
Establishes a method of describing upper limb amputation stumps and proposes a standardized system for recording the descriptive information which can be easily incorporated in reports and forms and should also be capable of ready adaptation for computer analysis. Deliberately aims at defining the minimum information to be described.
|
Published |
1993-07 |
Edition : 1 |
Number of pages : 15 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 18192-1:2011/Amd 1:2018 |
Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test — Amendment 1 |
|
Published |
2018-12 |
Edition : 2 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 8548-3 |
Prosthetics and orthotics — Limb deficiencies — Part 3: Method of describing upper limb amputation stumps |
Establishes a method of describing upper limb amputation stumps and proposes a standardized system for recording the descriptive information which can be easily incorporated in reports and forms and should also be capable of ready adaptation for computer analysis. Deliberately aims at defining the minimum information to be described.
|
Under development |
|
Edition : 2 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-4:1998 |
Prosthetics and orthotics — Limb deficiencies — Part 4: Description of causal conditions leading to amputation |
|
Published |
1998-07 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8548-5:2003 |
Prosthetics and orthotics — Limb deficiencies — Part 5: Description of the clinical condition of the person who has had an amputation |
ISO 8548-5:2003 establishes a method of describing those attributes of a person who has had an amputation which may affect their rehabilitation.
|
Published |
2003-07 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-1:1989 |
Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and external orthoses |
Includes more than 40 definitions of terms used to describe artificial limbs, the anatomy of those parts of the human body and the personal and procedures involved in the practice of prosthetics and orthotics. It does not apply to breast or other external prostheses, dental prostheses or internal ones.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-1:2020 |
Prosthetics and orthotics — Vocabulary — Part 1: General terms for external limb prostheses and external orthoses |
This document defines general terms used to describe external limb prostheses and orthoses, and the personnel involved in the practice of prosthetics and orthotics.
NOTE 1 The complete range of levels of limb amputation are listed and defined in ISO 8549-2. The complete range of classes of orthoses are listed and defined in ISO 8549-3.
This document does not apply to breast, ocular or other external prostheses used to replace other parts of the human body, nor to dental prostheses or orthoses.
NOTE 2 For the purposes of this document, the abbreviated term 'prosthetics' and its derivatives only apply to external limb prosthetics. The abbreviated term 'orthotics' and its derivatives only apply to external orthotics.
|
Published |
2020-09 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-2:1989 |
Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses and wearers of these prostheses |
Includes 19 definitions of terms used to describe the level of amputation of limbs and limb deficiencies present at birth and their correction. It complements part 1 of this ISO 5849 series.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-2:2020 |
Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses and wearers of these prostheses |
This document defines terms used to describe external limb prostheses and the wearers of external limb prostheses.
NOTE 1 The types of component used in the construction of prostheses are classified and described in the ISO 13405 series.
NOTE 2 For the purposes of this document, the abbreviated term ?prosthetics' and its derivatives only apply to external limb prosthetics.
|
Published |
2020-09 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 8549-2 |
Prosthetics and orthotics — Vocabulary — Part 2: Terms relating to external limb prostheses |
|
Under development |
|
Edition : 3 |
Number of pages : 4 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-3:1989 |
Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to external orthoses |
Definitions of 22 terms relating to external orthoses that encompass joints. It does not include terms for orthoses which only encompass limb segments as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine. It complements parts 1 and 2 of the ISO 5849 series.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637:2010/Amd 1:2013 |
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators — Amendment 1: Revision to Figure 2 — Main fitting dimensions of dialysis fluid inlet and outlet ports |
|
Withdrawn |
2013-04 |
Edition : 3 |
Number of pages : 1 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-3:2020 |
Prosthetics and orthotics — Vocabulary — Part 3: Terms relating to orthoses |
This document defines terms relating to orthoses.
This document does not include terms for orthoses that only encompass limb segments, as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine.
NOTE 1 The types of components used in the construction of orthoses are classified and described in ISO 13404.
NOTE 2 For the purposes of this document the abbreviated term ?orthotics' and its derivatives only apply to external orthotics.
|
Published |
2020-09 |
Edition : 2 |
Number of pages : 8 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-4:2014 |
Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation |
ISO 8549-4:2014 specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.
|
Withdrawn |
2014-11 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8549-4:2020 |
Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation |
This document specifies a vocabulary for the description of surgical limb amputations, amputation procedures, and persons who have had an amputation.
|
Published |
2020-09 |
Edition : 2 |
Number of pages : 5 |
Technical Committee |
01.040.11
Health care technology (Vocabularies)
;
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8551:2003 |
Prosthetics and orthotics — Functional deficiencies — Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis |
ISO 8551:2003 establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.
|
Withdrawn |
2003-08 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8551:2020 |
Prosthetics and orthotics — Functional deficiencies — Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosis |
This document establishes a method of describing the person to be treated with an orthosis, the clinical objectives of treatment and the functional requirements of the orthosis.
|
Published |
2020-03 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8615:1991 |
Implants for surgery — Fixation devices for use in the ends of the femur in adults |
Specifies the materials, dimensions, surface finish, packaging and marking. Applies to nails and screws, nail plates and blade plates, fixation devices. Several figures illustrate form and finish.
|
Published |
1991-11 |
Edition : 1 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637-1:2017 |
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.
|
Published |
2017-11 |
Edition : 1 |
Number of pages : 22 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 8637-1 |
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
|
Deleted |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 8637-1 |
Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.
ISO 8637-1:2017 does not apply to:
- extracorporeal blood circuits;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
- reprocessing procedures and equipment.
NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637‑2.
|
Under development |
|
Edition : 2 |
Number of pages : 34 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 2245:1972 |
Shaped insulating refractory products — Classification |
|
Withdrawn |
1972-06 |
Edition : 1 |
Number of pages : 2 |
Technical Committee |
81.080
Refractories
|
| ISO 8637-2:2018 |
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3.
NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.
|
Published |
2018-07 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 8637-2 |
Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
|
Under development |
|
Edition : 2 |
Number of pages : 26 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637-3:2018 |
Extracorporeal systems for blood purification — Part 3: Plasmafilters |
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
|
Published |
2018-07 |
Edition : 1 |
Number of pages : 14 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/CD 8637-3 |
Extracorporeal systems for blood purification — Part 3: Plasmafilters |
|
Deleted |
|
Edition : 2 |
|
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 8637-3 |
Extracorporeal systems for blood purification — Part 3: Plasmafilters |
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
|
Under development |
|
Edition : 2 |
Number of pages : 18 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637:1989 |
Haemodialysers, haemofilters and haemoconcentrators |
ISO 8637:1989 specifies requirements for haemodialysers, including those of
coil, hollow-fibre and parallel-plate design, haemofilters and haemoconcentrators
for single use for humans. Requirements for materials of construction and test
methods for biocompatibility, validation of sterility, non-pyrogenicity and
certain performance characteristics are not included.
ISO 8637:1989 does not apply to devices assembled and sterilized by the user,
nor to devices for the extracorporeal blood circuit, plasma filters, haemoperfusion
devices, vascular access devices, blood pumps, pressure monitors of the extracorporeal
circuit, air detection devices or systems to prepare, maintain or monitor dialysing
fluid.
|
Withdrawn |
1989-07 |
Edition : 1 |
Number of pages : 18 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637:2004 |
Cardiovascular implants and artificial organs — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 8637:2004 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as 'the device', for use for humans.
ISO 8637:2004 is not applicable to extracorporeal blood circuits, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysate, systems used to perform haemofiltration or haemoconcentration, reprocessing procedures and equipment.
Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters are specified in ISO 8638.
|
Withdrawn |
2004-10 |
Edition : 2 |
Number of pages : 17 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8637:2010 |
Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ISO 8637:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans.
|
Withdrawn |
2010-07 |
Edition : 3 |
Number of pages : 18 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8638:1989 |
Extracorporeal blood circuit for haemodialysers, haemofilters and haemoconcentrators |
This standard specifies the requirements for the extracorporal blood circuit applied in the haemodialysis in a single use. Design materials, test methods for biocompatibility, restrictions of sterilisation and some performance characteristics are not included. Furtherly it does not cover the hardware of neither haemodialysers, haemofilters and haemoconcentrators nor blood pumps, pressure monitors, air detectors, etc. systems, etc.
|
Withdrawn |
1989-09 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8638:2004 |
Cardiovascular implants and artificial organs — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
ISO 8638:2004 specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
ISO 8638:2004 is not applicable to haemodialysers, haemodiafilters or haemofilters, plasmafilters, haemoperfusion devices, vascular access devices, blood pumps, pressure monitors for the extracorporeal blood circuit, air detection devices, systems to prepare, maintain or monitor dialysing fluid, or systems intended to perform haemofiltration or haemoconcentration.
Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637.
|
Withdrawn |
2004-10 |
Edition : 2 |
Number of pages : 12 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8638:2010 |
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
ISO 8638:2010 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (hereafter referred to as “the device”) and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
|
Withdrawn |
2010-07 |
Edition : 3 |
Number of pages : 13 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8827:1988 |
Implants for surgery — Staples with parallel legs for orthopaedic use — General requirements |
Specification of dimensions, tolerances, forms and designation of staples. The different forms are illustrated. The informative annex gives guidance on the selection and use of staples.
|
Published |
1988-10 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8828:1988 |
Implants for surgery — Guidance on care and handling of orthopaedic implants |
This standard gives guidance on the procedures for receiving, storing, transporting, handling, cleaning and sterilization of the implants in the clinical range. Guidance on cautions necessary for preparing implants for the use are also outlined. It does not apply to the implant manufacturer.
|
Withdrawn |
1988-10 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 8828:2014 |
Implants for surgery — Guidance on care and handling of orthopaedic implants |
ISO 8828:2014 specifies the recommended procedures for handling orthopaedic implants, hereafter referred to as implants, from receipt at the hospital until they are implanted or discarded.
This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements.
This guidance does not apply to the implant manufacturer. However, it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers.
|
Withdrawn |
2014-11 |
Edition : 2 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9268:1988 |
Implants for surgery — Metal bone screws with conical under-surface of head — Dimensions |
Bone screws for particular applications are not covered by this standard. The different forms are illustrated. The informative annex A shows the interrelationship of International Standards dealing with bone screws, bone plates and relevant tools.
|
Published |
1988-12 |
Edition : 1 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9269:1988 |
Implants for surgery — Metal bone plates — Holes and slots corresponding to screws with conical under-surface |
Specification of dimensions and tolerances of the holes and slots in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO 9268. This standard does not deal with the shape and dimensions of plates or with the spacing of the holes and slots. The different forms are illustrated. The informative annex A shows the interrelationship of International Standards dealing with bone screws, bone plates and relevant tools.
|
Published |
1988-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 9325:1989 |
Implants for surgery — Partial and total hip joint prostheses — Recommendations for simulators for evaluation of hip joint prostheses |
The recommendations cover units, test specimen, test conditions and test methods for evaluating the characteristics of hip joint prostheses by means of simulators. Form changings of bearing surfaces are not included. The informative annexes A to C include examples for a cleaning method for specimen and a lubricator for the wearing test.
|
Withdrawn |
1989-06 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 9326:1989 |
Implants for surgery — Partial and total hip joint prostheses — Guidance for laboratory evaluation of change of form of bearing surfaces |
Guidance on the measurement of changings of the form, for instance wear and tear, creeping, plastic deformation, etc., and on available procedures when the test is performed in a simulator. Sensitivity, advantages, disadvantages and the measurement equipment of the different methods are compared in a table.
|
Withdrawn |
1989-06 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9583:1993 |
Implants for surgery — Non-destructive testing — Liquid penetrant inspection of metallic surgical implants |
The method for detecting and evaluating internal imperfections shall be performed in accordance with the requirements in ISO 3452. Guidance on the acceptance limits for surface imperfections in the raw and finally treated and finished conditions is given in annex A.
|
Published |
1993-10 |
Edition : 1 |
Number of pages : 3 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9584:1993 |
Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
The method for detecting and evaluating internal imperfections shall be performed in accordance with the requirements in ISO 1027 and ISO 5579. Guidance on the acceptance limits for internal imperfections is given in annex A.
|
Published |
1993-10 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/DIS 9584.2 |
Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants |
|
Under development |
|
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9585:1990 |
Implants for surgery — Determination of bending strength and stiffness of bone plates |
Describes a test method for straight plates but may also be used for ones having a small initial curvature. The method is neither recommended for plates of a length less than 50 mm nor for those designed to be used with, or forming parts of, intramedullary devices.
|
Published |
1990-12 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 9586:1988 |
Implants for surgery — Usage of terms "valgus" and "varus" in orthopaedic surgery |
Both terms have been in use for centuries but their meaning seams to have varied from time to time. The present usage has developed in a haphazard manner, such that consistent definition of the terms seems to be impossible. This Technical Report points out the differences in usage of both terms so that anomalies of usage, espacially in relation to the hip joint, may be clearly understood and confusion minimized.
|
Withdrawn |
1988-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9713:1990 |
Neurosurgical implants — Self-closing intracranial aneurysm clips |
Intended to insure that appropriate and comparable information is supplied for each clip in order to facilitate the choice of the correct clip by the surgeon. Specifies the requirements for clips intended for permanent intracardial implantation.
|
Withdrawn |
1990-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9713:2002 |
Neurosurgical implants — Self-closing intracranial aneurysm clips |
ISO 9713:2002 describes characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for marking, packaging, sterilization and for labelling and accompanying documentation. In addition it gives a method for the measurement of closing force.
ISO 9713:2002 is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
|
Withdrawn |
2002-09 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9713:2022 |
Neurosurgical implants — Self-closing intracranial aneurysm clips |
This document establishes the characteristics of self-closing aneurysm clips intended for permanent intracranial implantation and specifies requirements for their marking, packaging, sterilization and for labelling and accompanying documentation. In addition, it gives a method for the measurement of closing force.
This document is not applicable to malleable clips, or clips intended to be used during the course of surgery and removed before wound closure (temporary clips).
NOTE In this document when not otherwise established, the term “implant” refers to the self-closing intracranial aneurysm clips.
|
Published |
2022-01 |
Edition : 3 |
Number of pages : 9 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9714-1:1991 |
Orthopaedic drilling instruments — Part 1: Drill bits, taps and countersink cutters |
Part 1 of ISO 9714 specifies materials and mechanical properties, dimensions and marking requirements for the mentioned instruments made of stainless steel for use in orthopaedic surgery with bone screws as specified in ISO 5835. Instruments made of other materials and coatings may be included at a later revision. The interrelationship of International Standards dealing with bone screws and relevant tools is shown for information in annex A.
|
Withdrawn |
1991-03 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 9714-1:2012 |
Orthopaedic drilling instruments — Part 1: Drill bits, taps and countersink cutters |
ISO 9714-1:2012 specifies materials and mechanical properties, dimension and marking requirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws specified in ISO 5835.
|
Published |
2012-06 |
Edition : 2 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO/TR 9966:1989 |
Implants for surgery — Biocompatibility — Selection of biological test methods for materials and devices |
|
Withdrawn |
1989-09 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10310:1995 |
Neurosurgical implants — Marking and packaging of implantable neural stimulators |
Specifies requirements for marking, labelling, packaging and accompanying documentation for implantable neural stimulators intended for stimulation of the nervous system (brain, spinal cord, peripheral nerves and adjacent structures). Also covers implanted or external ancillary components, including the external control and programming equipment used for the activation or adjustment of neural stimulators. Does not specify indications or contraindications for the use of implantable neural stimulators, nor testing or the range of normal operating variable parameters.
|
Withdrawn |
1995-03 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-1:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 1: Test configurations |
Gives test configurations for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Defines coordinate systems, the location of a test sample and the position of the line of application of the test force.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-2:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 2: Test samples |
Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies types, selection, preparation and alignment of test samples and responsibilities for test preparation.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 8 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-3:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 3: Principal structural tests |
Contains procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies methods to be used in carrying out principal static and cyclic tests, requirements for accuracy of the tests and criteria to be met in order to secure compliance with this part of ISO 10328.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 16 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-4:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 4: Loading parameters of principal structural tests |
Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 7 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-5:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 5: Supplementary structural tests |
Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the values of the test forces and moments for the supplementary structural tests.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 11 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-6:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 6: Loading parameters of supplementary structural tests |
Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies supplementary structural tests.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 6 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 10328-7:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 7: Test submission document |
Describes procedures for static and cyclic strength tests of lower-limb prostheses. Applies to transtibial (below-knee), knee-disarticulation and transfemoral (above-knee) prostheses. Specifies the information that must be provided on the test submision document which accompanies each item for testing.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 5 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|
| ISO 6743-15:2000 |
Lubricants, industrial oils and related products (class L) — Classification — Part 15: Family E (Internal combustion engine oils) |
|
Withdrawn |
2000-03 |
Edition : 1 |
Number of pages : 4 |
Technical Committee |
75.100
Lubricants, industrial oils and related products
|
| ISO 10328-8:1996 |
Prosthetics — Structural testing of lower-limb prostheses — Part 8: Test report |
Describes procedures for static and cyclic strength test for lower-limb prostheses. Specifies the information that shall be provided in the test report which is prepared for each test conducted in accordance with ISO 10328 and ISO 10328-4 and/or ISO 10328-5 and ISO 10328-6.
|
Withdrawn |
1996-12 |
Edition : 1 |
Number of pages : 38 |
Technical Committee |
11.040.40
Implants for surgery, prosthetics and orthotics
|