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NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
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Available format(s): Hardcopy, PDF
Superseded date: 31-03-2017
Language(s): English
Published date: 01-01-1998
Publisher: British Standards Institution
Foreword Introduction1 Scope 2 Normative references 3 Definitions 4 Intended performance 5 Design attributes6 Materials 7 Design evaluation 8 Manufacturing 9 Sterilization10 Packaging 11 Information supplied by the manufacturer Annex A (normative) - Classification of prostheses Annex B (informative) - Bibliography Annex C (informative) - Reference table EN 12006-2 and ISO/DIS 7198 Annex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
Defines specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.
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