1、BRITISH STANDARD BS EN ISO 16054:2002 Incorporating Amendment No. 1 to BS ISO 16054:2000 (renumbers the BS ISO as BS EN ISO 16054:2002) Implants for surgery Minimum data sets for surgical implants The European Standard EN ISO 16054:2002 has the status of a British Standard ICS 11.040.40 BS EN ISO 16
2、054:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 March 2001 BSI 7 January 2003 ISBN 0 580 37082 8 National foreword This British Standard i
3、s the official English language version of EN ISO 16054:2002. It is identical with ISO 16054:2000. The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery, which has the responsibility to: A list of organizations represented on this committee can be
4、obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the B
5、SI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquir
6、ers to understand the text; present to the responsible international/European committee any 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. Summary of pages This docum
7、ent comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to iv, pages 1 to 4, the Annex ZA page and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued
8、since publication Amd. No. Date Comments 14017 7 January 2003 Implementation of the European StandardEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO16054 May2002 ICS11.040.40 Englishversion ImplantsforsurgeryMinimumdatasetsforsurgicalimplants (ISO16054:2000) ImplantschirurgicauxEnsemblesminimau
9、xdedonnes relativesauximplantschirurgicaux(ISO16054:2000) ChirurgischeImplantateMindestdatenstzefr chirurgischeImplantate(ISO16054:2000) ThisEuropeanStandardwasapprovedbyCENon11April2002. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an
10、 Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemade
11、bytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands
12、,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.E
13、NISO16054:2002EForeword ThetextoftheInternationalStandardfromTechnicalCommitteeISO/TC150“Implantsfor surgery“oftheInternationalOrganizationforStandardization(ISO)hasbeentakenoverasa EuropeanStandardbyTechnicalCommitteeCEN/TC285“Nonactivesurgicalimplants“,the secretariatofwhichisheldbyNEN. ThisEurope
14、anStandardshallbegiventhestatusofanationalstandard,eitherbypublicationof anidenticaltextorbyendorsement,atthelatestbyNovember2002,andconflictingnational standardsshallbewithdrawnatthelatestbyNovember2002. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingco
15、untriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,Czech Republic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg, Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnitedKingdom. Endorsementnotice ThetextoftheInternationalStandardISO16054:2000hasbeen
16、approvedbyCENasa EuropeanStandardwithoutanymodification. NOTENormativereferencestoInternationalStandardsarelistedinannexZA(normative). ENISO16054:2002INTERNATIONAL STANDARD ISO 16054 First edition 2000-12-15 Reference number ISO 16054:2000(E) Implants for surgery Minimum data sets for surgical impla
17、nts Implants chirurgicaux Ensembles minimaux de donnes relatives aux implants chirurgicaux ENISO16054:2002ii ENISO16054:2002iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internat
18、ional 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 to be represented on that committee. International organizations, governmental and non-governmental, in liai- son wi
19、th ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Stan
20、dards 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. Attention is drawn to the possibility that some of the elements of this International Standard ma
21、y 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 Committee ISO/TC 150, Implants for surgery. Annex A of this International Standard is for information only. ENISO16054:2002iv
22、 Introduction The importance and utility of registry, tracking and retrieval analysis systems in understanding long term clinical per- formance of implant devices and in patient follow up in the event of unforeseen device malfunction is understood. This International Standard addresses the minimum i
23、nformation concerning the patient, the device manufacturer and the clinical and surgical procedures which needs to be collected to ensure efficient 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 p
24、urposes of retrieval analysis. Medical device regulators should consider inclusion of these minimum data requirements in the distribution chain to 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 d
25、ata items specified in this Inter- national Standard and, if desired, to transfer them to third party registers using automated methods. An informative annex to this International Standard provides references to technical standards which define mechanisms for auto- mation of both data collection and
26、 transmission. ENISO16054:2002ANRETNIITOLAN TSDNADRA ISO 50610002:4)E( 1 Implants for surgery Minimum data sets for surgical implants 1 Scope This International Standard defines minimum data sets for surgical implants to facilitate recording and international exchange of data for the purposes of imp
27、lant registry and tracking systems and for retrieval analysis. Minimum data collection requirements are specified for the purpose of implant 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 cor
28、e data require- ments to allow cross referencing between extended data sets for the purposes of retrieval analysis and research. This 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 ho
29、spitals and other medical facilities which carry out implant procedures. It specifies requirements for data items to be recorded by the 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 tim
30、e of any subsequent explant procedure. This International Standard is intended to define a minimum data set to be recorded for all implant 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 iden
31、tified devices or devices within a specified range of lot, batch or serial numbers, for the purpose of patient follow up. It is not the intent of this International Standard to provide a means of data recovery which is related to specific medical practitioners, medical facilities or manufacturers fo
32、r purposes other than patient follow up. NOTE Users of this International Standard should ensure compliance with appropriate national standards or regulations con- cerning data protection and handling. 2 Normative references The following normative documents contain provisions which, through referen
33、ce in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, 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 app
34、lying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain reg- isters of currently valid International Standards. ISO 13485, Quality systems Medical devices Part
35、icular requirements for the application of ISO 9001. ISO 8402, Quality management and quality assurance Vocabulary. 3 Terms and definitions 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 implantabl
36、e medical device any medical device or active medical device which is intended to be totally or partially introduced, surgically or medically, 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 t
37、o remain after the procedure for at least 30 days and which can only be removed by surgical or medical intervention ENISO16054:20022 NOTE ISO 13485 gives a separate definition for active implantable medical devices and specifically excludes these from the definition for implantable medical devices.
38、The above definition differs from that given in ISO 13485 in that the separate defini- tions for implantable 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 i
39、nto the human body, or used to replace an epithelial surface or the surface of the eye, or partially introduced 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 t
40、he act of surgical intervention by which an implantable medical device is removed from a patient 3.4 medical facility the person or organization responsible for maintaining the patient record NOTE 1 The medical facility is also, by definition, the final customer (see ISO 8402) in the distribution ch
41、ain. NOTE 2 In some cases hospitals may be considered suppliers, for example where patient records are the sole responsibility of individual surgeons practising within the hospital. 4D a t a s e t s 4.1 General For modular implantable medical devices which are supplied either separately or as kits,
42、each separately supplied component or each separate item of a kit shall be considered to be a unique and separate 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
43、(s) of an implantable cardiac pacemaker or defibrillator, and the cement and each of the separate components of a modular hip prosthesis. 4.2 Supplier 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 su
44、pplier in the distribution chain; b) customer identity; c) the device name or description and catalogue number as given 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 lev
45、el of the unique lot or batch or device. Where a supplier allocates new product catalogue numbers, device names or descriptions, 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 cha
46、in. Independent records of each separate supplier in a distribution chain shall, where known, include the identity of the original producer of the implantable medical device and those known to be in the supply chain. ENISO16054:20023 Supplier data records shall be maintained in such a way as to allo
47、w timely traceability of the implantable medical de- vices through the distribution 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 regulati
48、ons concerning data protection and handling. 4.3 Medical facility data The data 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 allow timely retrieval of the fo
