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As ISO 25539.1-2003 Cardiovascular Implants - Endovascular Devices Endovascular Prostheses | Sterilization (Microbiology) | Medical Device
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AS ISO 25539.
AS ISO 25539.1
Cardiovascular implantsEndovascular devices Part 1: Endovascular prostheses
This Australian Standard was prepared by Committee HE-012, Surgical Implants. It was approved on behalf of the Council of Standards Australia on 21 May 2003 and published on 30 June 2003.
Australian Society for Biomaterials Commonwealth Department of Health and Ageing Department of Defence (Australia) Medical Industry Association of Australia Inc Neurological Society of Australasia Royal Australasian College of Surgeons Royal Perth Hospital University of New South Wales University of Sydney
Standards are living documents which reflect progress in science, technology and systems. To maintain their currency, all Standards are periodically reviewed, and new editions are published. Between editions, amendments may be issued. Standards may also be withdrawn. It is important that readers assure themselves they are using a current Standard, which should include any amendments which may have been published since the Standard was purchased. Detailed information about Standards can be found by visiting the Standards Australia web site at www.standards.com.au and looking up the relevant Standard in the on-line catalogue. Alternatively, the printed Catalogue provides information current at 1 January each year, and the monthly magazine, The Global Standard, has a full listing of revisions and amendments published each month. We also welcome suggestions for improvement in our Standards, and especially encourage readers to notify us immediately of any apparent inaccuracies or ambiguities. Contact us via email at mail@standards.com.au, or write to the Chief Executive, Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001.
This Standard was issued in draft form for comment as DR 03181.
AS ISO 25539.12003
First published as AS ISO 25539.12003.
ISBN 0 7337 5341 8
This Standard was prepared by the Australian members of the Joint Standards Australia/Standards New Zealand Committee HE-012, Surgical Implants. After consultation with stakeholders in both countries, Standards Australia and Standards New Zealand decided to develop this Standard as an Australian, rather than an Australian/New Zealand Standard. This Standard is identical with and has been reproduced from ISO 25539-1:2003, Cardiovascular implantsEndovascular devicesPart 1: Endovascular prostheses. The objective of this Standard is to specify requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to AS ISO 14630, which specifies general requirements for the performance of non-active surgical implants. It is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. The terms normative and informative are used to define the application of the annex to which they apply. A normative annex is an integral part of a standard, whereas an informative annex is only for information and guidance. As this Standard is reproduced from an international Standard, the following applies: (a) (b) (c) Its number does not appear on each page of text and its identity is shown only on the cover and title page. In the source text this International Standard should read this Australian Standard. A full point substitutes for a comma when referring to a decimal marker.
References to International Standards should be replaced by references to Australian or Australian/New Zealand Standards as follows: Reference to International Standard ISO 7198 10993 10993-1 10993-3 Cardiovascular implants Tubular vascular prostheses Biological evaluation of medical devices Part 1: Evaluation and testing Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8: Selection and qualification of reference materials for Australian Standard AS ISO 7198 10993 10993.1 10993.3 Cardiovascular implants Tubular vascular prostheses Biological evaluation of medical devices Part 1: Evaluation and testing Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8: Selection and qualification of reference materials for
10993-4 10993-5 10993-6 10993-7 10993-8
10993.4 10993.5 10993.6 10993.7 10993.8
Reference to International Standard ISO 10993-9 biological tests Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systematic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Sterilization of health care productsRequirements for validation and routine control Industrial moist heat sterilization Medical devicesValidation and routine control of ethylene oxide sterilization Sterilization of health care productsRequirements for validation and routine control Radiation sterilization Quality systemsMedical devicesParticular requirements for the application of ISO 9001 Quality systemsMedical devicesParticular requirements for the application of ISO 9002 Clinical investigation of medical devices
Australian Standard AS ISO 10993.9 biological tests Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systematic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Sterilization of health care productsRequirements for validation and routine control Industrial moist heat sterilization Medical devicesValidation and routine control of ethylene oxide sterilization Sterilization of health care productsRequirements for validation and routine control Radiation sterilization Quality systemsMedical devicesParticular requirements for the application of ISO 9001 Quality systemsMedical devicesParticular requirements for the application of ISO 9002 Clinical investigation of medical devices Sterilization of single-use medical devices incorporating materials of animal originValidation and routine control of sterilization by liquid sterilants Non-active surgical implants General requirements
10993-10 10993-11 10993-12 10993-13
10993.10 10993.11 10993.12 10993.13
10993-14
10993.14
10993-15
10993.15
10993-16
10993.16
14155 14160
Sterilization of single-use medical 14160 devices incorporating materials of animal originValidation and routine control of sterilization by liquid sterilants Non-active surgical implants General requirements 14630
Introduction ........................................................................................................................................................ v 1 2 3 4 5 5.1 5.2 5.3
Scope...................................................................................................................................................... 1 Normative references ........................................................................................................................... 1 Terms and definitions........................................................................................................................... 2 Intended performance .......................................................................................................................... 3 Design attributes................................................................................................................................... 3 General ................................................................................................................................................... 3 Delivery system..................................................................................................................................... 4 Implant.................................................................................................................................................... 4 Materials................................................................................................................................................. 4 Design evaluation ................................................................................................................................. 5 General ................................................................................................................................................... 5 Delivery (and/or endovascular) system .............................................................................................. 5 Implant.................................................................................................................................................. 11 Preclinical in vivo evaluation ............................................................................................................. 19 Clinical evaluation............................................................................................................................... 22 Manufacturing ..................................................................................................................................... 25 Sterilization .......................................................................................................................................... 25 Products supplied sterile ................................................................................................................... 25 Products supplied non-sterile ........................................................................................................... 26 Sterilization residuals ......................................................................................................................... 26 Packaging ............................................................................................................................................ 26 Protection from damage in storage and transport .......................................................................... 26 Marking................................................................................................................................................. 27 Information supplied by the manufacturer....................................................................................... 27
6 7 7.1 7.2 7.3 7.4 7.5 8 9 9.1 9.2 9.3 10 10.1 10.2 10.3
Annex A (informative) Attributes of endovascular devices Technical and clinical considerations..... 29 Annex B (informative) Bench and analytical tests ........................................................................................ 36 Annex C (informative) Definitions of reportable clinical events .................................................................. 39 Bibliography ..................................................................................................................................................... 42
This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular prostheses and the methods of test that will enable their evaluation. It is the first part of a proposed three-part International Standard. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements. The Technical Specification was developed by first identifying the design requirements for endovascular implants and listing the potential implant and clinical failure modes. Tests were then identified to address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment. Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be undertaken.
1.1 This part of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. 1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. 1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses. 1.4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products. 1.5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the endovascular system (defined in 3.6), such as balloon angioplasty devices.
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 7198:1998, Cardiovascular implants Tubular vascular prostheses ISO 11134:1994, Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide sterilization ISO 11137:1995, Sterilization of health care products Requirements for validation and routine control Radiation sterilization ISO 10993 (all parts), Biological evaluation of medical devices ISO 11607:1997, Packaging for terminally sterilized medical devices ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes ISO 13488:1996, Quality systems Medical devices Particular requirements for the application of ISO 9002 ISO 14155 (all parts), Clinical investigation of medical devices for human subjects
AS ISO 25539.1-2003, Cardiovascular implants Endovascular devices Endovascular prostheses
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