ISO TR 14283-2004 Implants for surgery - Fundamental principles《外科植入物 基本原则》.pdf

1、 Reference number ISO/TR 14283:2004(E) ISO 2004TECHNICAL REPORT ISO/TR 14283 Second edition 2004-07-15 Implants for surgery Fundamental principles Implants chirurgicaux Principes fondamentaux ISO/TR 14283:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes

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6、 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2004 All rights reservedISO/TR 14283:2004(E) ISO 2004 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Terms and definitions. 1 3 General principles. 2 4 Specific pr

7、inciples regarding design and construction 3 4.1 Chemical, physical and biological properties 3 4.2 Infection and microbial contamination. 4 4.3 Construction and environmental properties 4 4.4 Implants with a measuring function 5 4.5 Protection against radiation. 5 4.5.1 General. 5 4.5.2 Intended ra

8、diation. 5 4.5.3 Unintended radiation 5 4.5.4 Instructions 5 4.6 Ionizing radiation 6 4.7 Principles for implants connected to or equipped with an energy source. 6 4.7.1 General. 6 4.7.2 Protection against electrical risks. 6 4.7.3 Protection against mechanical risks. 6 4.7.4 Protection against the

9、risks posed to the patient by energy supplies or substances 7 4.8 Information supplied by the manufacturer. 7 4.9 Clinical evaluation. 9 Annex A (informative) Correspondence to some regulatory documents. 10 A.1 General. 10 A.2 European Economic Area 10 A.3 Australia. 10 A.4 Canada. 10 A.5 China 11 A

10、.6 Japan 11 Bibliography . 15 ISO/TR 14283:2004(E) iv ISO 2004 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out throug

11、h ISO technical committees. 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 liaison with ISO, also take part in the work. ISO collaborat

12、es 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 2. The main task of technical committees is to prepare International Standard

13、s. 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 bodies casting a vote. In exceptional circumstances, when a technical committee has collected

14、 data of a different kind from that which is normally published as an International Standard (“state of the art”, for example), it may decide by a simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely informative in nature and does not have t

15、o be reviewed until the data it provides are considered to be no longer valid or useful. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 14283

16、 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second edition cancels and replaces the first edition (ISO/TR 14283:1995), the annex of which has been updated. ISO/TR 14283:2004(E) ISO 2004 All rights reserved vIntroduction Requirements on the design, manufacture and perf

17、ormance of implantable medical devices are developing in various ways in different countries and international regions. As the medical device industry is already active on a global basis, and is becoming more so, concern is growing as to the need for international and mutually recognized standards f

18、or the design and performance of such devices. In order for standards and legal or regulatory requirements to be compatible, they both need to be based on an understanding of the fundamental principles applicable to the implants. This Technical Report presents a compilation of these principles. The

19、structure of this report is derived and adapted from the Essential Requirements given in the European Council Medical Device Directives. This Technical Report is, by its nature, purely informative. When balancing risk and benefit to the patients, it is good practice to subject implants to a risk ana

20、lysis and this is implicit in this Technical Report. However, risk analysis cannot always identify all risks. Such uncertainty may be acceptable in the light of perceived benefits to the patient. Follow-up performance review can provide information to confirm the acceptability of the risk. The corre

21、spondence of the fundamental principles contained in this Technical Report with pre-existing national and/or regional requirements is contained in Annex A. The bibliography provides a list of standards that may be used to link these fundamental principles to standards giving product related requirem

22、ents and guidance on the analysis of risks associated with the use of implants. NOTE 1 This report is intended to be a basis for harmonized standards, but it is recognized that specific wording may be at variance with wording or definitions used in existing national documents, particularly in areas

23、related to “lifetime”, “intended use”, “normal conditions of use”, etc. NOTE 2 Should standards based on this Technical Report be recognized by national authorities having responsibility for approval for commercialization of such devices in their respective countries, the opportunity exists for the

24、rationalization and harmonization of such approval activities. The consequent overall cost reduction is to the benefit of all parties, particularly patients, health care providers, insurers and industry. TECHNICAL REPORT ISO/TR 14283:2004(E) ISO 2004 All rights reserved 1Implants for surgery Fundame

25、ntal principles 1 Scope This Technical Report provides fundamental principles for the design and manufacture of active or non-active implants in order to achieve the intended purpose. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 accessory

26、article which, while not being a medical device, is intended specifically by its manufacturer to be used together with a device to enable the device to be used as intended by its manufacturer 2.2 active medical device any medical device whose operation depends on a source of electrical energy or any

27、 source of power other than that directly generated by the human body or gravity and which acts by converting this energy NOTE Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considere

28、d to be active medical devices. 2.3 intended purpose use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials 2.4 labelling all written, printed or graphic matter affixed to a medical device or any o

29、f its containers or wrappers, or accompanying a medical device relating to identification, technical description, and use of the medical device, but excluding shipping documents NOTE Some regional and national regulations refer to “labelling” as “information supplied by the manufacturer”. ISO 13485:

30、2003 2.5 manufacturer natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his/her own name, regardless of whether these operations are carried out by that person him-/herself or on his/her behalf by a th

31、ird party ISO/TR 14283:2004(E) 2 ISO 2004 All rights reserved2.6 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings

32、for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, and which does not achieve

33、its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means NOTE Adapted from ISO 13485:2003. 2.7 medicinal product any substance or combination of substances presented for treating or preventing

34、disease in human beings or animals with a view to making a medical diagnosis, or for restoring, correcting or modifying physiological functions in human beings or in animals 2.8 surgical implant device which is intended to be totally introduced into the human body, or to replace an epithelial surfac

35、e or the surface of the eye by surgical intervention, and which is intended to remain in place after the procedure NOTE Any medical device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is

36、 also considered a surgical implant. 3 General principles 3.1 The implants should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of user

37、s or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. 3.2 The solutions adopted by the manufacturer fo

38、r the design and construction of the implants should conform to safety principles, taking into account the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: a) eliminate or reduce risks

39、 as far as possible (inherently safe design and construction); b) where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; c) inform users of the residual risks due to any shortcomings of the protection measures adopted. ISO

40、/TR 14283:2004(E) ISO 2004 All rights reserved 33.3 The implants should achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in 3.1, as specified by the manufacturer. 3.4 When

41、 the implant is subjected to stresses which can occur during normal conditions of use, the characteristics and performances referred to in 3.1, 3.2 and 3.3 should not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other person

42、s are compromised during the lifetime of the implant as indicated by the manufacturer. 3.5 The implants should be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage when tak

43、ing into account the instructions and information provided by the manufacturer. 3.6 Any undesirable side-effect should constitute an acceptable risk when weighed against the performances intended. 4 Specific principles regarding design and construction 4.1 Chemical, physical and biological propertie

44、s 4.1.1 The implants should be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Clause 3 on general principles. Particular attention should be paid to a) the choice of materials used, particularly as regards toxicity and, where appropriate,

45、flammability, b) the compatibility between the materials used and biological tissues, cells and body fluids, taking into account the intended purpose of the implant. 4.1.2 The implants should be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residue

46、s to the persons involved in the transport, storage and use of the implants and to the patients, taking into account the intended purpose of the product. Particular attention should be paid to the tissues exposed and to the duration and frequency of exposure. 4.1.3 The implants should be designed an

47、d manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures. If the implants are intended to administer medicinal products, they should be designed and manufactured in such

48、a way as to be compatible with the medicinal products concerned, according to the provisions and restrictions governing these products, and such that their performance is maintained in accordance with the intended use. 4.1.4 If an implant incorporates, as an integral part, a substance which, if used

49、 separately, may be considered to be a medicinal product as defined in 2.7 and which is liable to act upon the body with action ancillary to that of the implant, the safety, quality and usefulness of the substance should be verified, taking into account the intended purpose of the implant. 4.1.5 The implants should be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the implant. 4.1.6 Implants should be designed and manufactured in such a way as to reduce, as much as possible,