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1、INTERNATIONAL STANDARD IS0 15798:2001 TECHNICAL CORRIGENDUM 1 Published 2003-1 1-01 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION M W A P O f l H A R OPTAHHIHR no CTAHflAPTHIAUHH ORGANISATION INTERNATIONALE DE NORMALISATION Ophthalmic implants - Ophthalmic viscosurgical devices TECHNICAL CORRIGENDU
2、M 1 Implants ophtalmiques - Dispositifs ophtalmiques viscolastiques RECTIFICATIF TECHNIQUE I Technical Corrigendum 1 to IS0 15798:2001 was prepared by Technical Committee ISOTC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments Cover page The second element of
3、the title in French shall read: Dispositifs ophtalmiques viscolastiques Page 6, Subclause 5.3.8 Replace the first sentence by the following: The spectral transmittance of the finished product shall be recorded over the range 300 nm to 1 100 nm. ICs 11.040.70 Ref. No. IS0 15798:2001/Cor.l:2003(E) O I
4、S0 2003 -All rights reserved Published in Switzerland Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduction or networking permitted without license from IHS
5、 -,-,- INTERNATIONAL STANDARD IS0 15798 First edition 2001 -06-1 5 Ophthalmic implants - Ophthalmic viscosurgical devices Implants ophtalmiques - Dispositifs ophtalmiques viscochirurgicaux Reference number IS0 15798:2001(E) 0 IS0 2001 Copyright International Organization for Standardization Provided
6、 by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 15798:2001(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensi
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9、taken to ensure that the file is suitable for use by IS0 member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. O IS02001 All rights reserved. Unless otherwise specified, no part of this publication may be reprod
10、uced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IS0 at the address below or ISOs member body in the country of the requester. IS0 copyright office Case postale 56 CH-121 1 Geneva 20 Tel. + 41 22 7
11、49 O 1 11 Fax + 41 22 749 O 9 47 E-mail copyrightiso.ch Web www.iso.ch Printed in Switzerland O IS0 2001 - All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:
12、35:34 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 15798:2001 (E) Contents Page Foreword . iv 1 Scope 1 2 Normative references 1 Terms and definitions -2 3 4 Intended performance . 3 5 Design attributes 4 6 Design evaluation 6 7 Sterilization . 9 8 Product stability
13、. 10 9 Integrity and performance of the delivery system . 10 10 Packaging . 10 11 Information to be supplied by the manufacturer 10 Annex A (normative) Intra-ocular implantation test 12 Annex B (normative) Test for intra-ocular pressure 13 Annex C (informative) Microscopic assay for particulate matt
14、er . 14 Annex D (informative) Patient numbers for clinical trials . 19 Bibliography 20 0 IS0 2001 -All rights reserved iii Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:3
15、4 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 15798:2001(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carrie
16、d out through IS0 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. IS
17、0 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 by the technical committ
18、ees 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 subject of patent rights. IS0
19、 shall not be held responsible for identifying any or all such patent rights. International Standard IS0 15798 was prepared by Technical Committee ISOTTC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annexes A and B form an integral part of this Internati
20、onal Standard. Annexes C and D are for information only. iv O IS0 2001 - All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduction or networ
21、king permitted without license from IHS -,-,- INTERNATIONAL STANDARD IS0 15798:2001 (E) Ophthalmic implants - Ophthalmic viscosurgical devices 1 Scope This International Standard applies to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelas
22、tic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery. OVDs are not designed to have any pharmacological effect. This International Standard de
23、fines requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices. 2 Normative references The following normative documents c
24、ontain 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 not apply. However, parties to agreements based on this International Standard are encouraged t
25、o 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. Members of IS0 and IEC maintain registers of currently valid International Standards. IS0 10993-1 :
26、1997, Biological evaluation of medical devices - Part 1: Evaluation and testing. IS0 10993-2:1992, Biological evaluation of medical devices - Part 2: Animal welfare requirements. IS0 10993-6:1994, Biological evaluation of medical devices - Part 6: Tests for local effects afer implantation. IS0 10993
27、-9:1999, Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products. IS0 10993-1 6:1997, Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables. IS0 1 1 134:1994,
28、 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization. IS0 1 1 135: 1 994, Medical devices - Validation and routine control of ethylene oxide sterilization. IS0 1 1 137:1995, Sterilization of health care products - Requirements
29、 for validation and routine control - Radiation sterilization. IS0 1 1607:-), Packaging for terminally sterilized medical devices. IS0 13408-1 :1998, Aseptic processing of health care products - Part 1: General requirements. 1) To be published. (Revision of IS0 11607:1997) O IS0 2001 -All rights res
30、erved 1 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 15798:2001 (E) IS0 141 55:1996, Cli
31、nical investigation of medical devices. IS0 14630: 1997, Non-active surgical implants - General requirements. IS0 14971 -1 :1998, Medical devices - Risk management - Part 1: Application of risk analysis. IS0 15223:2000, Medical devices - Symbols to be used with medical device labels, labelling and i
32、nformation to be supplied. EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods. EN 1041 :1998, Information supplied by the manufacturer with medical devices. EN 12442-1:2000, Animal tissues and their derivates
33、utilized in the manufacture of medical devices - Part 1: Analysis and management of risk. EN 12442-2:2000, Animal tissues and their derivates utilized in the manufacture of medical devices - Part2 Controls on sourcing, collection and handling. EN 12442-3:2000, Animal tissues and their derivates util
34、ized in the manufacture of medical devices - Part3: Validation of elimination and/or inactivation of viruses and other transmissible agents. USP 24 c85, United States Pharmacopoeia, 24th revision, c85 Bacterial endotoxins test. 3 Terms and definitions For the purposes of this International Standard,
35、 the following terms and definitions apply. 3.1 delivery system sealed container in which the product is supplied and any additional components provided to introduce the product into the eye 3.2 elasticity tendency of a body to return to its original shape after being deformed in some way NOTE dimen
36、sions of the body). Elasticity is quantitatively defined as stress (the force generated within the body) divided by strain (the change in 3.3 lost to follow-up patient subject in the clinical trial for whom the final post-operative case report is overdue and who cannot be contacted despite extensive
37、 written and telephone follow-ups to determine their final clinical outcome 3.4 ophthalmic viscosurgical device OVD generic term that includes a variety of materials with viscous and/or viscoelastic properties, that are designed to create and maintain space, to protect intra-ocular tissues and to ma
38、nipulate tissues during surgery in the anterior segment of the human eye 2 O IS0 2001 -All rights resewed Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduct
39、ion or networking permitted without license from IHS -,-,- IS0 15798:2001 (E) 3.5 primary container vial or syringe that contains the OVD NOTE This container forms part of the delivery system 3.6 rheologically active component compound or mixture of compounds in the finished OVD giving the product v
40、iscous and/or viscoelastic properties 3.7 serious adverse event intra-operative or post-operative adverse event that is potentially sight-threatening NOTE Adapted from IS0 14155. 3.8 shear viscosity tendency of a substance to resist deformation when subjected to stress NOTE 1 Quantitatively, shear v
41、iscosity is the quotient of shear stress divided by shear rate in steady shear flow. NOTE 2 It is expressed in millipascal seconds (mPa.s) previously expressed in centipoise (cP). 3.9 sterile barrier pouch containing the product and delivery system that maintains sterility during transport and stora
42、ge 3.1 O storage container that part of the packaging intended to protect the device during transport and storage, containing a package insert and a sealed, sterile pouch within which is the product and delivery system 3.1 1 viscoelastic having both viscous and elastic properties 3.12 zero shear vis
43、cosity steady state shear viscosity at vanishing shear rate NOTE It is expressed in millipascal seconds (mPas) previously measured in centipoise (cP). 4 Intended performance The general requirements for the intended performance of non-active surgical implants outlined in IS0 14630 shall apply. In ad
44、dition, the manufacturer shall describe and document the functional characteristics of the OVD in terms of its: a) chemical composition; b) rheological properties; c) effectiveness in protecting the corneal endothelium. O IS0 2001 - All rights reserved 3 Copyright International Organization for Stan
45、dardization Provided by IHS under license with ISO Licensee=NASA Technical Standards 1/9972545001 Not for Resale, 04/18/2007 20:35:34 MDTNo reproduction or networking permitted without license from IHS -,-,- IS0 15798:2001(E) 5 Design attributes 5.1 General The general requirements for non-active su
46、rgical implants outlined in IS0 14630 shall apply. All testing requirements described below shall be performed with the finished, sterilized product. NOTE assurancekontrol programme. Tests described herein are intended to apply when qualifying materials but not necessarily apply as a routine quality
47、 The purity of water used shall be Water for Injection (in accordance with Pharmacopoeia Europe/USP 24/JP). 5.2 Characterization of the rheologically active components 5.2.1 Chemical description The manufacturer shall provide a description of each rheologically active component in the product. The r
48、aw materials used in its manufacture shall be listed, along with their quality specifications. These shall comply with recognized compendia1 standards wherever possible. If the rheologically active component is derived from animal sources the requirements of EN 12442-1, EN 12442-2, and EN 12442-3 shall apply. If the rheologically active component is a high-molecular mass organic polymer, the repeating subunits that comprise it shall be chemically identified and the linkages between them described. Any crosslinking shall a