BS ISO 5833-2002 Implants for surgery - Acrylic resin cements《外科植入物 丙烯酸树脂粘接剂》.pdf

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1、BRITISH STANDARD BS ISO 5833:2002 Implants for surgery Acrylic resin cements ICS 11.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS ISO 5833:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy C

2、ommittee, was published under the authority of the Standards Policy and Strategy Committee on 24 June 2002 BSI 24 June 2002 ISBN 0 580 39219 8 National foreword This British Standard reproduces verbatim ISO 5833:2002 and implements it as the UK national standard. It supersedes BS 7253-1:1993 which i

3、s withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/18, Surgical implant materials, to Subcommittee CH/18/1, Non-metallic materials, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its se

4、cretary. 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 BSI Electronic Catalogue or Br

5、itish 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 enquirers to understand the text; pres

6、ent 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 document comprises a front cover, an

7、inside front cover, the ISO title page, pages ii to iv, pages 1 to 22, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsINTERNATIONAL STANDARD ISO 5833 Secon

8、d edition 2002-05-01 Reference number ISO 5833:2002(E) Implants for surgery Acrylic resin cements Implants chirurgicaux Ciments base de rsine acryliqueISO 5833:2002(E) ii ISO 2002 Ar llithgr seresvde FDP dicslaimre This FDP fam elitnoc yt deddebme niayfep.seca In roccatiw ecnadA hycilop gnisnecil se

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13、 Fax + 14 47 2290 9 74 E-liam copyrightsio.ch Web wwwsi.oc.h Prni detni SztiwerldnaISO 5833:2002(E) ISO 2002 r llAithgs reservde iii Contents Page 1 Scope . 1 2 Term and definition . 1 3 Liquid component . 1 4 Powder component . 2 5 Liquid-powder mixture intended for syringe usage . 2 6 Liquid-powde

14、r mixture intended for use in dough state 2 7 Set and polymerized cement 3 8 Packaging . 3 9 Labelling . 3 Annexes A Determination of stability of liquid component 5 B Determination of doughing time of liquid-powder mixture of cement intended for dough usage 7 C Determination of maximum temperature

15、and setting time of liquid-powder mixture . 9 D Determination of intrusion of liquid-powder mixture of cement intended for dough usage . 13 E Determination of compressive strength of polymerized cement . 15 F Determination of bending modulus and bending strength of polymerized cement 19ISO 5833:2002

16、(E) iv ISO 2002 Ar llithgr seresvde Foreword 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 through ISO technical committees. Each member body i

17、nterested 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 collaborates closely with the International Electrotechn

18、ical 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 Standards adopted by the technical committees are circulated to the member bodies for voting. Public

19、ation 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 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all

20、such patent rights. International Standard ISO5833 was prepared by Technical Committee ISO/TC150, Implants for surgery, Subcommittee SC 1, Materials. This second edition cancels and replaces the first edition (ISO 5833:1992), which has been technically revised. Annexes A, B, C, D, E and F form a nor

21、mative part of this International Standard.INTERNATIONAL STANDARD ISO 5833:2002(E) ISO 2002 r llAithgs reservde 1 Implants for surgery Acrylic resin cements 1 Scope This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaq

22、ue and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile pow

23、der and of sterile liquid in forms suitable for mixing at the time of implantation. This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement. All requirements apply to, and all tests are intended to be per

24、formed on, the sterile product. 2 Term and definition For the purposes of this International Standard, the following term and definition apply. 2.1 unit of cement one package or vial of sterile premeasured powder component and one package or vial of sterile premeasured liquid component NOTE For ceme

25、nts in which the radio-opaque agent is supplied separately, the unit of cement includes the vial or package of premeasured radio-opaque powder component. 3 Liquid component 3.1 Appearance When inspected by normal or corrected vision, the liquid component shall be free from particles and other contam

26、inants. 3.2 Stability When tested as described in annex A, the flow time of the samples of liquid component shall not increase by more than . 3.3 Accuracy of contents When measured to an accuracy of , the volume of the liquid component of each of five units shall be withinof that stated on the packa

27、ge see 9.1 b). 10 % 0,1 ml 5%ISO 5833:2002(E) 2 ISO 2002 Ar llithgr seresvde 4 Powder component 4.1 General The powder component includes the polymer particles, initiator agents, and, if applicable, the radio-opaque agent. In some cases, the radio-opaque agent is supplied separately. 4.2 Appearance

28、When inspected by normal or corrected vision, the powder shall be free from agglomerates and extraneous material. 4.3 Accuracy of contents When weighed to an accuracy of , the mass of the powder component of each of five units shall be within of that stated on the package see 9.1 b). The components

29、used for the determinations specified in 3.3 and 4.3 may be used subsequently for other tests described in this International Standard, with the condition that no mass and/or volume loss for each cement component is produced, and all the requirements of clauses 3 and 4 are satisfied. 5 Liquid-powder

30、 mixture intended for syringe usage When determined by the methods given in Tables 1 and 2, the setting properties and the properties of the set cement shall comply with the values given in Tables 1 and 2. Table 1 Requirements and test methods for setting properties of liquid-powder mixtures Mixture

31、 Doughing time Setting time Maximum temperature Average Maximum deviation from average Test method Average Test method Average Maximum deviation from average Test method min min min Syringe usage (see clause 5) 6,5 to 15 Annex C 90 Annex C Dough state usage (see 6.1) 1,5 Annex B 3 to 15 Annex C 90 A

32、nnex C Table 2 Requirements and test methods for set and polymerized cement Average compressive strength Bending modulus Bending strength Test method Test method Test method MPa MPa MPa Annex E Annex F Annex F 0,1 g 5 % C C 5 5 5 70 1 800 50ISO 5833:2002(E) ISO 2002 r llAithgs reservde 3 6 Liquid-po

33、wder mixture intended for use in dough state 6.1 Setting properties, test methods and requirements When determined by the methods given in annexes B, C, D, E and F, the setting properties and the properties of the set cement shall comply with the values given in Tables 1 and 2. 6.2 Intrusion When de

34、termined as described in annex D, the average intrusion of at least one sample shall be not less than . 7 Set and polymerized cement Table 2 presents the requirements and test methods for set and polymerized cement. 8 Packaging 8.1 Each component of the cement shall be packaged and sterilized separa

35、tely using a suitable method. The liquid component shall be sterilized by ultrafiltration prior to being filled into an aseptic container. Each component shall be packaged in a double-layer sealed container. The components of a single unit of cement shall be further packaged in a container that shal

36、l contain the accompanying documentation as described in 9.2 and shall present the information as described in 9.1. Each component of the cement shall be packaged and sterilized in a double-layer sealed container and then packaged in an outer container which shall contain the accompanying documentat

37、ion. 8.2 In the case of cement being sold with two cement units per container, the requirements of 8.1 shall apply. 8.3 The materials of the package should not contaminate or permit contamination of the contents. The packaging should prevent damage to, or leakage of, the contents during transit and

38、storage and should be designed so that it is easy to open and facilitates aseptic presentation of the contents. 9 Labelling 9.1 Unit package At least the following information shall appear on the unit package of each cement unit: a) a reference to this International Standard (ISO 5833); b) a descrip

39、tion of the contents, including the mass of the powder component and the mass or volume of the liquid component, and the generic names of the constituents; c) the name and address of the manufacturer, and the supplier if different from the manufacturer; d) a warning that the package contains flammab

40、le liquid; e) a statement that the contents are sterile and a warning against the use of an opened or damaged package; f) an instruction to store the package at a temperature below , and away from strong light; g) the batch or lot numbers of the liquid and the powder component and the expiry date of

41、 the material. NOTE Legal requirements for labelling may apply in some countries. 2mm 25 CISO 5833:2002(E) 4 ISO 2002 Ar llithgr seresvde 9.2 Accompanying documentation At least the following information shall appear on the accompanying documentation (see clause 8): a) instructions for handling the

42、components and preparing the cement for use, including details of the equipment needed and an instruction to mix the entire contents of the cement component packages. The instructions shall emphasise the importance of minimizing the entrapment of air; b) instructions and recommendations for using th

43、e cement, including necessary precautions, and drawing attention to the expiry date marked on the package; c) a statement drawing attention to the toxic, hazardous and irritant properties associated with the handling and use of the components and the cement; d) a statement that high ambient or compo

44、nent temperatures will decrease, and low ambient or component temperatures will increase, the doughing, working and setting times of the cement; e) whether the cement is intended for use with a syringe or in the dough state; f) the relative proportions of the powder and liquid components, expressed

45、as a percent mass or volume fraction; g) a warning against re-sterilization of either the powder or liquid components; h) a statement that, once opened, any pack should be completely used or discarded and not retained for use on a later occasion. NOTE It is helpful to provide a graphical representat

46、ion of the effect of temperature on the length of the phases in cement curing, prepared from experimental data on the particular brand of cement.ISO 5833:2002(E) ISO 2002 r llAithgs reservde 5 Annex A (normative) Determination of stability of liquid component A.1 Principle The flow time (viscosity)

47、of the liquid component is determined before and after accelerated ageing by heating, and the increase in flow time after heating is calculated. Two units of the liquid component are tested. A.2 Apparatus A.2.1 Clean glass U-tube viscometer. A.2.2 Timing device, with an accuracy of . A.2.3 Means of

48、heating test specimens. A.3 Test conditions Condition the viscometer and the test specimens at for at least before beginning the test. Perform the viscosity measurements at . A.4 Procedure A.4.1 Fill the viscometer in the usual way with the liquid component. A.4.2 Record the flow time taken for the

49、meniscus to fall to the equilibrium level (time ). A.4.3 Heat an aliquot of the liquid component at for in the dark in a closed container, allow it to cool to and to remain at this temperature for at least . A.4.4 Repeat A.4.1 and A.4.2 and record the flow time (time ). A.4.5 Repeat A.4.1 to A.4.4 on a second unit of liquid component. A.5 Calculation and expression of results Calculate the percentage change in flow time for each unit of liquid component using the expression: 0,1 s (23 1) C1 h (