1、BRITISH STANDARD BS 6788-2: 1990 Neurosurgical implants Part 2: Specification for marking and packaging of implantable neural stimulatorsBS6788-2:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the
2、Board of BSI andcomes into effect on 31 May 1990 BSI 12-1999 The following BSI references relate to the work on this standard: Committee reference HCC/24 Draft for comment 88/50794 DC ISBN 0 580 17869 2 Committees responsible for this British Standard The preparation of this British Standard was ent
3、rusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/24, upon which the following bodies were represented: Association for Spina Bifida and Hydrocephalus British Association of Paediatric Surgeons British Surgical Trades Association Department of Health Electroence
4、phalographic Society Medical Research Council Medical Sterile Products Association Royal College of Surgeons of England Scottish Office Society for Research Into Hydrocephalus and Spina Bifida Society of British Neurological Surgeons Coopted members Amendments issued since publication Amd. No. Date
5、CommentsBS6788-2:1990 BSI 12-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Definitions 1 3 Non-invasive identification 1 4 Device marking 2 5 Packaging 2 6 Package marking 2 7 Accompanying documentation 2 Publications referred to Inside back coverBS6788-2:199
6、0 ii BSI 12-1999 Foreword This Part of BS6788 has been prepared under the direction of the Health Care Standards Policy Committee, and is the second Part of BS6788 to be published. BS6788-1 covers hydrocephalus shunts. The neural stimulators covered by this Part of BS6788 comprise two types, categor
7、ized according to the power source of the component that generates the stimulating current, as follows. a) Implant pulse generators. These are self-contained pulse generators having an internal power source, and which may be controlled or adjusted by radio-frequency (RF) or magnetic signals produced
8、 by an external programmer. b) Implant RF receivers. These require RF activation from an external source and therefore the implanted component usually contains no power source (although one may be fitted as a stand-by). Implant RF receivers are activated by external equipment which comprises an RF d
9、river and antenna. The RF driver, together with its power source, is usually housed in a portable container (the transmitter). The antenna may be integral with the transmitter or connected to it by a cable. It is intended to be placed next to the skin, near to the implanted RF receiver. In both type
10、s of stimulator, an implantable lead(s) is normally provided to carry current from the implant pulse generator or implant RF receiver to the stimulation electrodes. These leads may be integral with the generator or receiver, or may be separate. The leads may carry connectors, or separate connectors
11、and adaptors may be used. This Part of BS6788 applies to cables, leads, connectors, adaptors and electrodes whether they form part of an integral device or are separate components of a system capable of being assembled together. The purpose of this Part of BS6788 is to ensure that the neural stimula
12、tor or component thereof is adequately packaged and that the device and the packaging is labelled with sufficient information. This information needs to be readily available to the patient, surgical team and engineer so as to facilitate decision-making on such matters as the choice of device, the me
13、thods of implantation, adjustment and fault diagnosis and to convey user precautions. Therefore, this Part of BS6788 does not specify indications or contraindications for the use of implantable neural stimulators, nor does it specify methods of construction or testing or what the range of normal ope
14、rating variable parameters should be. It does, however, require that information on these matters be included in the documentation accompanying each implant pulse generator or implant RF receiver. The preparation of further Parts of BS6788 to cover other neurosurgical implants is under consideration
15、. It is recommended that implantable neural stimulators and components should be manufactured in accordance with the recommendations in the “Guide to Good Manufacturing Practice for Medical Equipment” 1) . 1) Published by the Department of Health and Social Security, and available from Her Majestys
16、Stationery Office. ISBN0113208332.BS6788-2:1990 BSI 12-1999 iii It is recommended that if implantable neural stimulators and components are supplied in the sterile condition, they should be manufactured in accordance with the recommendations in the “Guide to Good Manufacturing Practice for Sterile M
17、edical Devices and Surgical Products” 2) . A 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
18、. Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages1to 6, an inside back cover 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
19、 front cover. 2) Published by the Department of Health and Social Security, and available from Her Majestys Stationery Office. ISBN0113207700.iv blankBS6788-2:1990 BSI 12-1999 1 1 Scope This Part of BS6788 specifies requirements for the marking, labelling, packaging and accompanying documentation fo
20、r implantable neural stimulators intended for stimulation of the central nervous system (brain, spinal cord and adjacent structures). It also covers implanted or external ancillary components, including the external control and driving equipment used for the activation or adjustment of neural stimul
21、ators. This Part of BS6788 does not cover external nerve, muscle or electroconvulsive stimulators, radio-frequency (RF) diathermy or stereotaxic lesion-generating equipment, or percutaneous stimulating electrode assemblies or components. NOTEThe titles of the publications referred to in this standar
22、d are listed on the inside back cover. 2 Definitions For the purposes of this Part of BS6788, the definitions given in BS6324 apply together with the following. 2.1 neural stimulator a device for electrically stimulating the central nervous system (brain, spinal cord and adjacent structures), compri
23、sing a pulse generator and all ancillary components, implanted or external to the body, necessary for its function and control 2.2 implant pulse generator an implantable device, containing its own power source, that can generate pulses to stimulate the central nervous system continuously or intermit
24、tently 2.3 programmer (controller) an external device for controlling or adjusting an implant pulse generator 2.4 implant RF receiver an implantable device, usually without its own power source, that can generate pulses to stimulate the central nervous system using radio-frequency (RF) power transmi
25、tted to it by a transmitter and antenna 2.5 transmitter (driver box) a portable container, having pulse generating and modulating circuits for controlling implant RF receivers NOTEThe transmitter usually contains a power source. It may also contain the antenna. There may be some user-accessible cont
26、rols and some internally-adjustable controls. 2.6 antenna a transmitting coil or loop intended for the activation of implant RF receivers NOTEThe antenna may be housed in the transmitter, or may be separate. 2.7 cable an insulated wire or conductor intended to connect a transmitter to an antenna, ex
27、ternal to the body, with or without an integral connector at one or both ends NOTEA cable may contain more than one wire or conductor. 2.8 implant lead an insulated wire or conductor intended to be implanted and to connect an implant pulse generator or RF receiver to stimulation electrode(s), with o
28、r without an integral connector at one or both ends NOTEAn implant lead may contain more than one wire, or conductor. 2.9 connector a separate implantable component intended to make electrical connections between implantable components 2.10 adaptor a component that allows the interconnection of othe
29、rwise electrically or physically incompatible components 2.11 stimulation electrode (Referred to in the text as an “electrode”.) Electrically conducting part(s) usually the termination of an implant lead(s) which is designed to form an interface with body tissue or body fluid and which carries the s
30、timulation current 2.12 unit pack a pack containing a single unit or kit 2.13 multiple pack a pack containing one or more unit packs 3 Non-invasive identification Each implant pulse generator and implant RF receiver shall have a means of identifying the manufacturer and the model designation non-inv
31、asively after implantation. NOTEExamples of non-invasive marking are radio-opaque lettering and telemetry.BS6788-2:1990 2 BSI 12-1999 4 Device marking Implant pulse generators, implant RF receivers, programmers and transmitters shall be permanently marked with at least the following information: a)
32、the name and/or identifying mark of the manufacturer; b) the model designation of the device; c) the serial number, preceded by identifying wording or abbreviation, e.g. “serial number”, “SN”. 5 Packaging 5.1 Unit packs Each complete neural stimulator or separate component shall be packaged in a uni
33、t pack. Each unit pack shall be supplied with one copy of the relevant accompanying documentation specified in clause7. In order to gain access to the accompanying documentation, it shall not be necessary to penetrate the package layer that maintains the sterility of devices supplied in the sterile
34、condition. 5.2 Multiple packs One or more unit packs shall be packaged in a multiple pack. NOTEThe multiple packs should protect the contents during normal handling, transit and storage. 6 Package marking NOTEThe markings should be readily readable, should remain legible after normal handling and tr
35、ansit, and should not adversely affect the contents. 6.1 Unit packs The unit pack shall bear at least the following information: a) a description of the contents, including the model designation(s); b) the name and address of the manufacturer and/or supplier; c) the traceability reference(s) of the
36、contents, i.e. 1) for components that are required to be marked with a serial number (seeclause4), the serial number expressed as given in itemc) of clause4; 2) for other components, the lot number(s), preceded by identifying wording or abbreviation, e.g.“lot”, “batch”. d) the “use-by” or equivalent
37、 date for the contents preceded by identifying wording or abbreviation, e.g. “use-by”, “exp”; e) if appropriate, the word “STERILE”, or if non-sterile, a warning statement to that effect; f) if appropriate, the words “for single use” or an equivalent phrase; g) written or pictorial instructions for
38、opening the unit pack; h) a list of all the documentation enclosed. 6.2 Multiple packs The multiple pack shall bear at least the following information: a) the name and address of the manufacturer and/or supplier; b) the number of unit packs contained and a description of the contents including model
39、 designation and serial and/or lot number(s), expressed as in itemc) of6.1. 7 Accompanying documentation 7.1 Implantable components 7.1.1 General Each unit pack containing an implantable component shall be supplied with the appropriate accompanying documentation specified in7.1.2 and/or7.1.3. 7.1.2
40、Implant pulse generators and implant RF receivers a) A registration document, at least in triplicate, bearing at least the following: 1) an instruction that one copy of the document be returned to the manufacturer or agent after implantation of the device; 2) the model designation of the device; 3)
41、the serial number of the device see itemc) of clause4; 4) the name and address of the manufacturer and/or supplier; 5) space for the following: i) the identity of the patient; ii) the date of implantation; iii) the name and address of the centre at which the device was implanted. b) An identificatio
42、n card bearing at least the following: 1) an instruction that the card be retained by the patient; 2) the model designation of the device; 3) the serial number of the device see itemc) of clause4; 4) the name and address of the manufacturer and/or supplier; 5) space for the following: BS6788-2:1990
43、BSI 12-1999 3 i) the identity of the patient; ii) the date of implantation; iii) the name and address of the centre at which the device was implanted; c) Details of the generic composition of any antibiotic, antibacterial or other pharmacologically active coating material and/or leachable material.
44、d) A technical information sheet, specific to the type of component contained in the unit pack, which shall bear at least the information specified in1) or2) as relevant to the contents, giving the range of values for each parameter where appropriate. 1) Implant pulse generators: i) the model design
45、ation of the device; ii) the model designation(s) of appropriate programmer(s), if any; iii) the pulse frequency (expressed in hertz or pulses per second); iv) the pulse waveform and its amplitude as shipped and at maximum adjustable output; v) the pulse duration (expressed in milliseconds or micros
46、econds); vi) the cycle on and cycle off times for devices that are intended to stimulate cyclically; vii) the ramp up and ramp down times; viii) the expected device longevity for continuous use at50% of maximum power output; ix) if applicable, instructions for recharging or renewing the power source
47、; x) the means of external adjustment of the implant pulse generator if any, or a statement that no means of external adjustment are provided; xi) if supplied non-sterile, recommended methods of sterilizing the implant pulse generator and the maximum permitted number of sterilizing cycles; xii) the
48、date of issue of the technical information sheet. 2) Implant RF receivers: i) the model designation of the device; ii) the carrier frequency (expressed in kilohertz or megahertz); iii) the pulse waveform and its amplitude as shipped and at maximum adjustable output; iv) the model designation(s) of t
49、he appropriate transmitter(s); v) the model designation(s) of the appropriate antenna(e); vi) if supplied non-sterile, recommended methods of sterilizing the implant RF receiver and the maximum permitted number of sterilizing cycles; vii) the date of issue of the technical information sheet. 7.1.3 Other implantable components a) Details of the generic composition of any antibiotic, antibacterial or other pharmacologically active coating material and/or leachable material. b) A technical information sheet, specific to the type of component contained in the unit pack, whic
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