ASTM F1542-94(2000)
(Specification)Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)
Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips (Withdrawn 2009)
ABSTRACT
This specification covers the requirements for specific characteristics and appropriate test requirements for, and disclosure of self-closing aneurysm clips that are intended for permanent implantation. Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.
SCOPE
1.1 This specification covers requirements for the specific characteristics of self-closing aneurysm clips that are intended for permanent implantation. Appropriate test requirements are also included.
1.2 Since all of the properties that contribute to aneurysm clip performance may not be known, this specification is intended to reflect the state of our knowledge to date.
1.3 Miniatures of "microclips" that are not intended for the obliteration of aneurysms are excluded from this specification.
WITHDRAWN RATIONALE
This specification covers requirements for the specific characteristics of self-closing aneurysm clips that are intended for permanent implantation. Appropriate test requirements are also included.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this specification was withdrawn in March 2009 in accordance with section 10.5.3.1 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F 1542 – 94 (Reapproved 2000)
Standard Specification for
the Requirements and Disclosure of Self-Closing Aneurysm
Clips
This standard is issued under the fixed designation F 1542; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope F 560 Specification for Unalloyed Tantalum for Surgical
Implant Applications
1.1 This specification covers requirements for the specific
F 562 Specification for Wrought Cobalt-Nickel-Chromium-
characteristics of self-closing aneurysm clips that are intended
Molybdenum Alloy for Surgical Implant Applications
for permanent implantation. Appropriate test requirements are
F 563 Specification for Wrought Cobalt-Nickel-Chromium-
also included.
Molybdenum-Tungsten-Iron Alloy for Surgical Implant
1.2 Since all of the properties that contribute to aneurysm
Applications
clip performance may not be known, this specification is
F 688 Specification for Wrought Cobalt-Nickel-Chromium-
intended to reflect the state of our knowledge to date.
Molybdenum Alloy Plate, Sheet, and Foil for Surgical
1.3 Miniatures of “microclips” that are not intended for the
Implants
obliteration of aneurysms are excluded from this specification.
F 700 Practice for Care and Handling of Intracranial Aneu-
2. Referenced Documents rysm Clips and Instruments
F 748 Practice for Selecting Generic Biological Test Meth-
2.1 ASTM Standards:
ods for Materials and Devices
F55 Specification for Stainless Steel Bar and Wire for
F 981 Practice for Assessment of Compatibility of Bioma-
Surgical Implants
terials (Non-Porous) for Surgical Implants with Respect to
F56 Specification for Stainless Steel Sheet and Strip for
Effect of Materials in Muscle and Bone
Surgical Implants
2.2 ISO Standard:
F67 Specification for Unalloyed Titanium for Surgical
ISO TC 150
Implant Applications
F75 SpecificationforCastCobalt-Chromium-Molybdenum
3. Requirements
Alloy for Surgical Implant Applications
3.1 General—This section contains requirements for the
F90 Specification for Wrought Cobalt-Chromium-
disclosure of information on aneurysm clip force measure-
Tungsten-Nickel Alloy for Surgical Implant Applications
ments and requirements for labeling the materials and biocom-
F 136 Specification for Wrought Titanium 6A1-4V ELI
patibility of the device.
Alloy for Surgical Implant Applications
3.2 Performance Disclosure:
F 138 Specification for Stainless Steel Bar and Wire for
3.2.1 Force (See X1.2)—The manufacturer shall disclose
Surgical Implants (Special Quality)
the closing force (measured in g) exerted by the blades when
F 139 Specification for Stainless Steel Sheet and Strip for
tested in accordance with 4.2.
Surgical Implants (Special Quality)
3.2.2 Force Range—The manufacturer shall measure each
F 361 Practice for Assessment of Compatibility of Metallic
clipasdefinedin3.2.1andreporteithertheclosingforceofthe
Materials for Surgical Implants with Respect to Effect of
individual clip, a minimum closing force for that specific clip,
Materials on Tissues
or a range within which the specific clip lies. If a range is
F 469 Practice for Assessment of Compatibility of Nonpo-
reported, defined ranges shall be no greater than 610 % of the
rous Polymeric Materials for Surgical Implants with Re-
median force.
gard to Effect of Materials on Tissues
3.2.3 Materials:
3.2.3.1 The manufacturer shall disclose the generic names
This specification is under the jurisdiction of ASTM Committee F04 on
of the materials used in the manufacture of the clip. ASTM
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.31 on Neurosurgical Standards.
Current edition approved Aug. 15, 1994. Published October 1994.
Discontinued 1991—See Annual Book of ASTM Standards, Vol 13.01.
3 5
Annual Book of ASTM Standards, Vol 13.01. Available from American National Standards Institute, 25 W. 43rd St., 4th
Discontinued—See Annual Book of ASTM Standards, Vol 13.01. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1542 – 94 (2000)
material specification nomenclature shall be used whenever (1) Blade Gripping Surfaces:
available. If the clips are made of multiple components, the (a) Smooth,
name of the material for each component shall be disclosed. (b) Serrated, and
3.2.3.2 Clips will be manufactured so as to be nonferromag- (c) Other (describe).
netic. The aneurysm clip must possess the following material (2) Clip Body:
property in order to be judged as nonferromagnetic. The force (a) Polished,
exerted on a finished aneurysm clip by a 1.5 tesla whole body
(b) Matte,
MRImagnetmustnotexceedthegravitationalforceontheclip (c) Satin, and
(that is, its own weight).
(d) Other (describe).
3.2.3.3 (See X1.4)—The materials and alloys used in aneu- (3) Material Treatment:
rysmclipsconformingtothisspecificationshouldbefabricated (a) Passivated,
in accordance with one of the followingASTM specifications:
(b) Electropolish, and
F55,F56,F67,F75,F90,F 136,F 138,F 139,F 560,F 562, (c) Other (describe).
F 563, F 688, ISO TC 150, or subsequently approved ASTM
3.5 Labeling Requirements (See X1.5)—The labeling for
Committee F04 standards. Clips manufactured with nonap- aneurysm clips within the scope of this specification must
proved materials must be labeled with a statement that they are
comply with the following requirements as a minimum:
made of a material for which there is no ISO or ASTM 3.5.1 Unit Labeling—Each clip will have imprinted on it a
Committee F04 standard.
unique code to allow traceability in accordance with FDA
3.3 Biocompatibility—Aneurysm clips should be biocom- guidelines.
patible with the tissue in which they are intended to be
3.5.2 The following information shall be available with the
implanted. Components shall meet the biologic compatibility unit package:
requirements of Practices F 361, F 469, F 748, and F 981,or
3.5.2.1 Manufacturer’s identification or lot number;
other equivalent practices wherever applicable.
3.5.2.2 Blade geometry (3.4.2.1);
3.4 Clip Nomenclature Disclosure:
3.5.2.3 Blade length (3.4.2.2);
3.4.1 General—This section contains requirements for a
3.5.2.4 Blade width (3.4.2.2);
standard nomenclature for self-closing aneurysm clips.
3.5.2.5 Gripping surface (3.4.2.4);
3.4.2 The manufacturer shall use the following type nomen-
3.5.2.6 Force (4.2);
clature to describe its clips and disclose this information where
3.5.2.7 Manufacturer’s name;
applicable:
3.5.2.8 Identification of catalog number;
3.4.2.1 Blade Geometry:
3.5.2.9 Composition of material(s), including ASTM mate-
(1) Straight,
rial specifications, if applicable, from which the clip is made;
(2) Angled, and
(3) Curved, 3.5.2.10 Specification of the ferromagnetic property(s) of
(4) Angled tip, the aneurysm clip or its component (see 4.3).
(5) Vessel encircling, 3.5.3 Product Information—As a minimum, the following
(6) Fenestrated, data should be available in the manufacturer’s and distributor’s
ordering information.
(7) Bayonet, and
(8) Other (describe). 3.5.3.1 Blade geometry (3.4.2.1);
3.5.3.2 Blade le
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