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1、INTERNATIONAL STANDARD ISO 16054 First edition 2000-12-15 Reference number ISO 16054:2000(E) ISO 2000 Implants for surgery Minimum data sets for surgical implants Implants chirurgicaux Ensembles minimaux de donnes relatives aux implants chirurgicaux ISO 16054:2000(E) ii ISO 2000 All rights reserved
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5、00 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec- tronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs mem- ber body in the
6、 country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland -,-,- ISO 16054:2000(E) ISO 2000 All rights reserved iii Foreword ISO (the International Organization for Standa
7、rdization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical com- mittees. Each member body interested in a subject for which a technical committee has been established has the right
8、 to be represented on that committee. International organizations, governmental and non-governmental, in liai- son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International
9、 Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International 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 bod
10、ies casting a vote. Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 16054 was prepared by Technical Committe
11、e ISO/TC 150,Implants for surgery. Annex A of this International Standard is for information only. -,-,- ISO 16054:2000(E) iv ISO 2000 All rights reserved Introduction The importance and utility of registry, tracking and retrieval analysis systems in understanding long term clinical per- formance of
12、 implant devices and in patient follow up in the event of unforeseen device malfunction is understood. This International Standard addresses the minimum information concerning the patient, the device manufacturer and the clinical and surgical procedures which needs to be collected to ensure efficien
13、t and rapid international patient fol- low up should it be required. It also provides the core data set to allow linkage of different registries for the purposes of retrieval analysis. Medical device regulators should consider inclusion of these minimum data requirements in the distribution chain to
14、 the end user as a progression of the requirements of ISO 13485. Users of this International Standard are advised that it is possible to collect all the data items specified in this Inter- national Standard and, if desired, to transfer them to third party registers using automated methods. An inform
15、ative annex to this International Standard provides references to technical standards which define mechanisms for auto- mation of both data collection and transmission. INTERNATIONAL STANDARDISO 16054:2000(E) ISO 2000 All rights reserved 1 Implants for surgery Minimum data sets for surgical implants
16、 1Scope This International Standard defines minimum data sets for surgical implants to facilitate recording and international exchange of data for the purposes of implant registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of i
17、mplant tracking to allow recall for product correction or pa- tient follow up in the event of unforeseen device malfunction. The minimum data set also fulfils the core data require- ments to allow cross referencing between extended data sets for the purposes of retrieval analysis and research. This
18、International Standard is applicable to the manufacturers and distributors of medical devices intended for per- manent implant, i.e. more than 30 days and to those hospitals and other medical facilities which carry out implant procedures. It specifies requirements for data items to be recorded by th
19、e manufacturers and distributors of perma- nently implantable medical devices and by hospitals and other medical facilities at both the time of implant and at the time of any subsequent explant procedure. This International Standard is intended to define a minimum data set to be recorded for all imp
20、lant and explant events, as well as providing for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch or serial numbers, for the purpose of patient follow up. It is not th
21、e intent of this International Standard to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers for purposes other than patient follow up. NOTEUsers of this International Standard should ensure compliance with appropriate national s
22、tandards or regulations con- cerning data protection and handling. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of,
23、any of these publica- tions do not apply. However, parties to agreements based on this International Standard are encouraged to investi- gate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative d
24、ocument referred to applies. Members of ISO and IEC maintain reg- isters of currently valid International Standards. ISO 13485,Quality systems Medical devices Particular requirements for the application of ISO 9001. ISO 8402,Quality management and quality assurance Vocabulary. 3Terms and definitions
25、 For the purposes of this International Standard, the terms and definitions given in ISO 13485 and ISO 8402 (but see 3.1) and the following apply. 3.1 implantable medical device any medical device or active medical device which is intended to be totally or partially introduced, surgically or medical
26、ly, into the human body or by medical intervention into a natural orifice, or to replace an epithelial surface or the surface of the eye, and which is intended to remain after the procedure for at least 30 days and which can only be removed by surgical or medical intervention -,-,- ISO 16054:2000(E)
27、 2 ISO 2000 All rights reserved NOTEISO 13485 gives a separate definition for active implantable medical devices and specifically excludes these from the definition for implantable medical devices. The above definition differs from that given in ISO 13485 in that the separate defini- tions for impla
28、ntable medical devices and active implantable medical devices are combined into one. 3.2 implant event the act of surgical intervention by which an implantable medical device is totally introduced into the human body, or used to replace an epithelial surface or the surface of the eye, or partially i
29、ntroduced into the human body, and which is intended to remain in place after the procedure for at least 30 days and which can only be removed by medical or surgical intervention 3.3 explant event the act of surgical intervention by which an implantable medical device is removed from a patient 3.4 m
30、edical facility the person or organization responsible for maintaining the patient record NOTE 1The medical facility is also, by definition, the final customer (see ISO 8402) in the distribution chain. NOTE 2In some cases hospitals may be considered suppliers, for example where patient records are t
31、he sole responsibility of individual surgeons practising within the hospital. 4Data sets 4.1General For modular implantable medical devices which are supplied either separately or as kits, each separately supplied component or each separate item of a kit shall be considered to be a unique and separa
32、te implantable medical de- vice subject to recording as unique and separate implant and explant events. Examples of separate modular compo- nents are: the pulse generator and electrode lead(s) of an implantable cardiac pacemaker or defibrillator, and the cement and each of the separate components of
33、 a modular hip prosthesis. 4.2Supplier data The data items a) to d) shall be recorded and retained by each supplier in the distribution chain as follows: a)the identity of the previous supplier in the distribution chain; b)customer identity; c)the device name or description and catalogue number as g
34、iven in the product information of the previous supplier which uniquely identifies the type of device; d)serial number or lot or batch number sufficient to identify the device to a level of the unique lot or batch or device. Where a supplier allocates new product catalogue numbers, device names or d
35、escriptions, or serial, lot or batch numbers, that supplier shall maintain records which link the new identifiers with those provided by the previous sup- plier in the distribution chain. Independent records of each separate supplier in a distribution chain shall, where known, include the identity o
36、f the original producer of the implantable medical device and those known to be in the supply chain. -,-,- ISO 16054:2000(E) ISO 2000 All rights reserved 3 Supplier data records shall be maintained in such a way as to allow timely traceability of the implantable medical de- vices through the distrib
37、ution chain. The data may be transmitted to a third party registry for archiving purposes. Users of this International Standard should ensure that any such transmission complies with relevant national standards or regulations concerning data protection and handling. 4.3Medical facility data The data
38、 items a) to j) defined as follows shall be recorded and retained by the medical facility for each separate im- plant event. For explant events, as many of the data items from a) to j) shall be recorded as are available to the medical facility. These data should be maintained in such a way as to all
39、ow timely retrieval of the following data items for a set of pa- tients who have been implanted with a specific device type or a specific range of lot, batch or serial numbers: a)place of implant event and/or explant event; b)date of implant event and/or explant event; c)identity of the responsible
40、clinician; d)patient identity; e)supplier identity and address; f)the device name or description and catalogue number as given in the suppliers product information which uniquely identifies the type of device; g)serial number or lot or batch number sufficient to identify the device to a level of the
41、 unique lot or batch or device; h)primary clinical indication for implant or explant, which may be selected from a predefined list; i)anatomical location of implant, including side where applicable; j)disposition (location or storage) of the explanted device. Medical facility records shall, where kn
42、own, include the identity of the original producer of the implantable medical device and those suppliers known to be in the supply chain. Medical facility data shall be maintained in such a way as to allow expeditious traceability of the implantable medical devices. Data shall be maintained for a pe
43、riod appropriate to the device taking into consideration the expected per- formance lifetime of the device. The data may be transmitted to a third party registry for archiving purposes. Users of this International Standard should ensure that any such transmission complies with relevant national stan
44、dards or regulations concerning data protection and handling. ISO 16054:2000(E) 4 ISO 2000 All rights reserved Annex A (informative) Automated device labelling and data capture Users of this International Standard are advised that the collection of the data items specified in this International Stan
45、dard and, if required, the transmission of these data to third party registers may be achieved by automated methods. This annex provides reference to other publications which provide specifications for automated data collec- tion methods and for formats for electronic data interchange. NP 15418,EAN/
46、UPC Application Identifiers and FACT Data identifiers. NP 15420,Bar coding Symbology Specification EAN/UPC. NP 15417,Bar coding Symbology Specification Code 128. The Health Industry Bar Code (HIBC) supplier labelling standard. HL7: Application Protocol for Electronic Data Exchange in Healthcare Environments. HL7s Implementation Support Guide. Appropriate standards under development by ISO/IEC JTC 1/SC 31. EN 800,Bar Coding Symbology Specification Code 39. -,-,- ISO 16054:2000(E) ICS 11.040.40 Price based on 4 pages ISO 2000 All rights reserved -,-,-