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1、 Reference number ISO 14949:2001(E) ISO 2001 INTERNATIONAL STANDARD ISO 14949 First edition 2001-10-15 Implants for surgery Two-part addition- cure silicone elastomers Implants chirurgicaux lastomres de silicone deux composants rticulation par raction daddition Copyright International Organization f
2、or Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In acc
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5、nting. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2001 All rights reserved. Unless otherwise specified, no part of this
6、 publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211
7、 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 ii ISO 2001 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for
8、Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) ISO 2001 All rights reserved iii Contents Page Foreword.iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Formulation4 4.1 Composition.4 4.2 Raw mater
9、ials assessment.4 5 Biocompatibility.5 6 Characterization and testing 5 6.1 Test slab preparation 5 6.2 Identification 5 6.3 Purity testing5 6.4 Cure rate.6 6.5 Physicomechanical properties and characterization 7 7 Documentation.7 7.1 Data sheet.7 7.2 Certificate of analysis7 Annex A (normative) Det
10、ermination of substances soluble in hexane .8 Annex B (normative) Determination of volatile matter12 Bibliography14 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo
11、 reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) iv ISO 2001 All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Sta
12、ndards is normally carried out through 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
13、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 Standards adopted
14、 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 may be the subj
15、ect of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 14949 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. Annexes A and B form a normative part of this International Stan
16、dard. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) ISO 2001 All rights res
17、erved v Introduction Silicones are commercially available in a variety of physical forms and formulations. Silicone-cure products often employ cure mechanisms that utilize metals, free radicals and/or atmospheric moisture. This International Standard was undertaken to describe a subset of silicones
18、with a successful history of use in implant applications; namely, those utilizing two-part addition-cure (platinum-based) chemistry. It was developed in response to a need to standardize the raw materials, formulation, processing, characterization testing and documentation of two-part addition-cure
19、silicone elastomers targeted as implants for surgery. Two-part addition-cure silicone elastomer is a thermoset elastomer and is commercialized as a two-part (non- crosslinked) product. The two parts should be thoroughly mixed in a fixed ratio before shaping by extrusion, press- or injection-moulding
20、 and crosslinking at elevated temperatures. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- Cop
21、yright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- INTERNATIONAL STANDARD ISO 14949:2001(E) ISO 2001
22、All rights reserved 1 Implants for surgery Two-part addition-cure silicone elastomers 1 Scope This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partial
23、ly or totally) of surgical implants. 2 Normative 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, any of these publications do
24、not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Memb
25、ers of ISO and IEC maintain registers of currently valid International Standards. ISO 34-1:1994, Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces ISO 48:1994, Rubber, vulcanized or thermoplastic Determination of hardness (hardness bet
26、ween 10 IRHD and 100 IRHD) ISO 527-2:1993, Plastics Determination of tensile properties Part 2: Test conditions for moulding and extrusion plastics ISO 3417:1991, Rubber Measurement of vulcanization characteristics with the oscillating disc curemeter ISO 6502:1999, Rubber Guide to the use of curemet
27、ers ISO 10993-1:1997, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-5:1999, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity 3 Terms and definitions For the purposes of this International Standard, the following terms and definition
28、s apply. 3.1 catalyst organometallic complex, typically containing platinum substituted by ligands made of any suitable combination of the elements carbon, hydrogen, oxygen, chlorine or silicon (with the exclusion of aromatic rings), which initiates a chemical reaction between a polymer and crosslin
29、king agent NOTE The catalyst may be dispersed in a silicone oligomer, polymer or mixture of these, such as RMe2SiO(SiMe2O)x(SiMeRO)ySiMe2R where R and R are methyl or vinyl groups. Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical
30、 Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) 2 ISO 2001 All rights reserved 3.2 crosslinking agent monomer, polymer, silicate or any combination of these, typically of the structure RMe2SiO(SiM
31、e2O)x(SiRMeO)ySiMe2R where R is typically a methyl group or hydrogen, that on curing provides a crosswise connection to parallel polymer chains NOTE Excess SiH is recommended (not required) before curing to ensure that the cure is total and that no residual Si-vinyl reactive entities exist, thus pro
32、viding better elastomer stability. 3.3 filler reinforcing agent for the purposes of this International Standard silicate or high purity amorphous silica NOTE 1 Such agents are commercially known as fumed or precipitated silica. NOTE 2 Silica can be treated with silylating agents, for example, those
33、of the formula Me3SiX or Me2SiX2 where X is a hydrolysable group, or polysiloxane oligomer of the formula HOMe2SiO(SiMe2O)p(SiMeRO)qSiMe2OH where R is a methyl or a vinyl group. NOTE 3 Agents that impart radiopacity to the elastomer (e.g. BaSO4) may have reinforcing properties. 3.4 inhibitor compoun
34、d or material that has the effect of slowing down or stopping a chemical reaction such as crosslinking 3.5 lot batch defined quantity of material manufactured in a single or multi-step process such that the material obtained can be considered as homogeneous NOTE in the case of a continuous process,
35、the term corresponds to a defined fraction of the production, characterized by its intended homogeneity. 3.6 manufacturer company who manufactures the final medical device in question 3.7 raw materials materials from which two-part addition-cure silicone elastomer is manufactured 3.8 silicone elasto
36、mer synthetic rubber obtained by the crosslinking of silicone polymer chains essentially made of repeat siloxane units EXAMPLE Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:
37、40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) ISO 2001 All rights reserved 3 3.9 silicone polymer any polymer or combination of polymers of medium or high molecular mass of the structure RMe2SiO(SiMe2O)x(SiMeRO)ySiMe2R, where R is typically a methy
38、l, vinyl or hydroxyl group but might also be a fluoro, phenyl or other group and where R is typically a methyl or vinyl group but might also be a fluoro, phenyl or other group EXAMPLE 1 EXAMPLE 2 EXAMPLE 3 both R and R are methyl, phenyl, fluoro or other suitable organic groups. NOTE The definition
39、of the polymer and its substituted groups is taken very broadly, as it is not the function of this International Standard to limit the number or the type of substituent groups present; however, for the purposes of this International Standard the definition only relates to materials with available pr
40、eclinical biocompatibility data (see clause 5) and a well-established history of safe international use in implant applications. 3.10 supplier company who manufactures and/or supplies the two-part silicone elastomer used for the production of the medical device in question 3.11 treating agent monome
41、r, oligomer or polymer used to coat the outer surface of silica to reduce the reactivity of the silica Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction
42、 or networking permitted without license from IHS -,-,- ISO 14949:2001(E) 4 ISO 2001 All rights reserved 3.12 two-part addition-cure silicone elastomer elastomer formed by crosslinking silicone polymer chains via an addition reaction between the vinyl functional groups of a vinyl silicone polymer an
43、d the silicon hydride of a crosslinking agent containing SiH functions NOTE The reaction requires the presence of a catalyst, usually an organometallic complex of platinum. EXAMPLE 4 Formulation 4.1 Composition The defined raw materials shall be used in a formulation as defined in Table 1. Table 1 G
44、eneral formulation for two-part addition-cure silicone elastomers Compound Percentage range (% mass fraction) Silicone polymer 60 to 80 Reinforcing agent less than 40 Crosslinking agent 1 to 5 Catalyst 0,5 Inhibitor 1,0 4.2 Raw materials assessment Both during product development and on an audit bas
45、is (at least once a year or every tenth production lot), the supplier of the two-part addition-cure elastomer shall assess the raw materials (see 3.8) as follows. a) Structure and functionality of polymer The structure and functionality of the polymer(s) used shall be determined by a suitable method
46、 such as nuclear magnetic resonance spectroscopic analysis (see 2 for further information). b) Purity of silica The purity of the silica used shall be assessed by elemental analysis or any other suitable method, and the result should be expressed as (mg Si obtained/theoretical mass) 100 = % mass fra
47、ction Si. c) Structure and purity of treating agent(s) The structure and purity of the treating agent(s) used shall be determined by a suitable method such as infrared spectroscopy (see 2 for further information). Copyright International Organization for Standardization Provided by IHS under license
48、 with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/19/2007 03:40:03 MDTNo reproduction or networking permitted without license from IHS -,-,- ISO 14949:2001(E) ISO 2001 All rights reserved 5 d) Structure of the crosslinking agent(s) The structure of the crosslinking agent(s) used shall be determined by a suitable method such as