《BS-ISO-7197-1997.pdf》由会员分享,可在线阅读,更多相关《BS-ISO-7197-1997.pdf(20页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS ISO 7197:1997 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components ICS 11.040.40 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 This British Standard, having been prepared under
2、 the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 February 1998 BSI 04-1999 ISBN 0 580 29164 2 National foreword This British Standard reproduces verbatim ISO 7197:1997 and implements it as the UK national
3、standard. It supersedes BS 6788-1:1986 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/24, Neurosurgical implants, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee an
4、y enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references T
5、he British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A
6、 British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a
7、 front cover, an inside front cover, pages i and ii the ISO title page, pages ii to iv, pages 1 to 11 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments is
8、sued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 BSI 04-1999i Contents Page National forewordInside front cover Forewordiii Text of ISO 71971 Licensed Copy: sheffieldun sheffieldun,
9、 na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 71
10、97:1997 ii BSI 04-1999 Contents Page Forewordiii 1Scope1 2Normative references1 3Definitions1 4General requirements for hydrocephalus shunts and accessory devices3 5Test methods4 6Unit container packaging10 7Marking of devices and information supplied by the manufacturer10 8Accompanying documentatio
11、n11 Figure 1 Example of a test rig for determining opening and closing pressures and influence of outlet pressure6 Figure 2 Configuration for testing valves for freedom from reflux8 Figure 3 Example of test rig for determination of long-term functional stability9 Descriptors: Medical equipment, disp
12、osable equipment, sterile equipment, surgical implants specifications, tests, marking packaging, instructions. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 BSI 04-1999iii Foreword ISO (the International Organization for S
13、tandardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the ri
14、ght to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft Intern
15、ational Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 7197 was prepared by Technical Committee ISO/TC 150, Impla
16、nts for surgery, Subcommittee SC 3, Neurosurgical implants. This second edition cancels and replaces the first edition (ISO 7197:1989), which has been technically revised. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Cop
17、y: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 BSI 04-19991 Introduction A hydrocephalus shunt system typically consists of three basic elements: (1) an inflow (proximal) catheter, which drains cerebrospinal fluid (CSF) from the ventri
18、cular system, lumbar subarachnoid space or extraventricular CSF space and transmits it to (2) a valve which regulates the differential pressure or controls flow through the system, and (3) an outflow (distal) catheter which drains CSF into the cardiovascular system, the peritoneal cavity or other su
19、itable drainage site. In addition, specialized accessory devices, such as reservoirs, siphoning-preventing devices and on-off valves and filters, are added at the discretion of the physician to modify performance or adapt the basic system to the particular needs of the patient. 1 Scope This Internat
20、ional Standard specifies requirements for sterile, single-use hydrocephalus shunts and components. This International Standard is applicable to but is not limited to: a) complete sterile, single-use hydrocephalus shunts of the one-piece type; or b) complete sterile, single-use hydrocephalus shunts o
21、f the multipiece type, supplied either assembled by the manufacturer or in kit form for assembly by the physician; or c) sterile, single-use shunt components which (individually or in combination) comprise shunt assemblies, for example: valves, valved catheters (catheter with integral valves), inflo
22、w or outflow catheters (such as arterial, peritoneal, ventricular catheters), connectors, implantable accessory devices (such as siphoning-preventing devices, measuring devices and reservoirs/priming devices). 2 Normative references The following standards contain provisions which, through reference
23、 in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most
24、 recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 10993-1:1992, Biological evaluation of medical devices Part 1: Guidance on selection of tests. ISO 11135:1994, Medical devices Validation and routine control o
25、f ethylene oxide sterilization. ISO 11137:1995, Sterilization of health care products Requirements for validation and routine control Radiation sterilization. ISO 11138-3:1995, Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization. IEC
26、 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. ASTM F640:1979, Standard Test Method for Radiopacity of Plastics for Medical Use. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 accessory device component of a hyd
27、rocephalus shunt designed to perform a specific additional function (i.e. on-off valve, siphoning-preventing device, measuring device, reservoirs, connectors, retaining clips and filters) 3.2 adjustable or programmable valve valve with multiple functional ranges that can be set prior to or after imp
28、lantation 3.3 chambered valve component of a hydrocephalus shunt containing one or more valve mechanisms separated by a compartment that may be designed to allow pumping of the fluid through the shunt or accessing to the shunt 3.4 closing pressure inlet pressure at which the valve closes to prevent
29、further flow 3.5 connector device intended for the joining and fixation of implantable shunt components 3.6 environmental pressure external pressure exerted on the valve or accessory components to mimic local tissue pressure in vivo 3.7 fluid compartment portion of the central nervous system (CNS) i
30、ncluding the ventricles and extraventricular structures such as subarachnoidal fluid collections, cysts, hygromas and syrinxes Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 2 BSI 04-1999 3.8 functional range representative
31、 pressure/flow characteristics of a shunt or shunt element NOTEThis is usually expressed in graphical form. 3.9 hydrocephalus state of excessive accumulation of cerebrospinal fluid (CSF) within the ventricular system of the head due to a disturbance of secretion, flow or absorption 3.10 hydrocephalu
32、s shunt one-piece device or multi-piece device or combination of devices intended to be surgically implanted in the body of a patient with hydrocephalus or other disturbance of the CSF circulation and designed to divert CSF from a fluid compartment in the CNS to a internal delivery site in another p
33、art of the body or an external collection site (external shunt), for the purpose of diminishing elevated intracranial pressure (ICP) or CSF volume 3.11 one-piece hydrocephalus shunt assembly one-piece complete single-use hydrocephalus shunt assembled by the manufacturer, typically consisting of an i
34、nflow catheter, pressure-activated flow-controlling device or combination of devices and an outflow catheter and/or accessory devices 3.12 inflow catheter; proximal catheter part of a hydrocephalus shunt that is inserted into the cerebral ventricles or any other site in the craniospinal axis to prov
35、ide access to a fluid compartment of the CNS (for example, into a lateral ventricle) and therefore constitutes the inflow pathway for the diversion of fluid through a shunt system 3.13 inlet pressure hydrostatic pressure at the inlet of the valve or active component 3.14 magnetic compatibility chara
36、cteristic of a device which can be used in environmental magnetic and electromagnetic fields of daily life without affecting the patient and/or shunt function 3.15 magnetic resonance (MR) compatibility characteristic of a device which can be used in diagnostic devices using magnetic resonance techni
37、ques without affecting the patient and/or shunt function NOTEAdverse effects of three main types may arise from lack of compatibility: a) displacement of the device or devices components leading to device migration, dysfunction or change in function due to high magnetic fields; b) local tissue damag
38、e because of induced currents and/or temperature rise; c) appreciable degradation of diagnostic images. 3.16 multipiece hydrocephalus shunt assembly complete sterile, single-use hydrocephalus shunt, supplied either assembled by the manufacturer or in kit form for assembly by the physician, typically
39、 consisting of an inflow catheter, pressure-activated flow-controlling device or combination of devices and an outflow catheter with requisite connectors and/or accessory devices required for assembly 3.17 on-off device accessory device that closes or opens the shunt system by external manipulation
40、3.18 opening pressure inlet pressure required to initiate flow through the valve 3.19 outflow catheter; distal catheter part of a hydrocephalus shunt assembly which provides an outflow pathway for the diversion of fluid from a compartment of the central nervous system to the peritoneal cavity, venou
41、s circulation or other internal or external delivery site 3.20 outlet pressure hydrostatic pressure at the outlet of the valve or active components 3.21 preassembled junction (non-modifiable junction) portion of a hydrocephalus shunt assembly which is assembled at the time of manufacture and is inte
42、nded to be permanently fixed and not modified during a surgical procedure ExampleThe site where the valve is chemically bonded to tubing is a preassembled junction. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:12:17 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 7197:1997 BSI 04-1999
43、3 3.22 pressure pressure relative to the actual ambient atmospheric pressure 3.23 reflux flow of fluid within a hydrocephalus shunt towards the inflow catheter 3.24 shunt (noun) see hydrocephalus shunt 3.25 shunt (verb) act of draining CSF from the CNS 3.26 shunt filter accessory device, intended to
44、 remove particulate matter from the CSF before it passes through the shunt, and designed to prevent the spread of neoplastic cells into the peritoneum or cardiovascular system following a shunting procedure 3.27 siphoning-preventing device device or component of device designed to prevent reflux due
45、 to differential pressure across the shunt system occurring when the position of the patient changes from horizontal to vertical, or the reverse 3.28 test specimen device, or sample of devices, representative of the population of devices 3.29 tip valve outflow catheter that includes the functions of
46、 the valve 3.30 valve element of a hydrocephalus shunt that a) is intended to resist reflux and b) functions to control the relationship between pressure and flow of cerebrospinal fluid NOTEValve constructions may be based on different principles, e.g. diaphragm valve, ball-cone valve, slit valve, n
47、eedle valve. 4 General requirements for hydrocephalus shunts and accessory devices 4.1 Physical requirements 4.1.1 Surface finish When examined with normal or corrected vision at a distance of 300 mm to 450 mm and at an illuminance of 2 150 lx 215 lx, the surface of shunts and accessory devices that
48、 have passed through all stages of manufacture, including sterilization, shall be smooth and free from irregularities, flash, moulding and extrusion defects, and extraneous particles. 4.1.2 Radiopacity All external parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque
49、markers. Tests shall be carried out in accordance with ASTM F640. 4.2 Mechanical requirements 4.2.1 General For any given accessory device and, where appropriate, the manufacturer shall subject device(s) (test specimens) to tests of those mechanical properties which are pertinent to its intended performance. 4.2.2 Resistance to breakage of preassembled junctions Preassembled junctions shall not break by subjecting a test specimen to an axial force of 10 N for 1 min, unless otherwise indicated by the manufacturer. 4.2.3 Leaktightness Non-modifiable j
链接地址:https://www.31doc.com/p-3752040.html