BS EN ISO 5840-1:2015

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Cardiovascular implants. Cardiac valve prostheses – General requirements

Published By	Publication Date	Number of Pages
BSI	2015	68

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, BSI

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PDF Catalog

PDF Pages	PDF Title
4	European foreword
5	Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices
7	Foreword
8	Introduction
10	1 Scope 2 Normative references
11	3 Terms and definitions
20	4 Abbreviations
21	5 Fundamental requirements 6 Device description 6.1 Intended use 6.2 Design inputs 6.2.1 Operational specifications 6.2.2 Performance specifications 6.2.3 Implant procedure
22	6.2.4 Packaging, labelling, and sterilization 6.3 Design outputs
23	6.4 Design transfer (manufacturing verification/validation) 6.5 Risk management
24	7 Design verification testing and analysis/design validation 7.1 General requirements 7.2 In vitro assessment 7.3 Preclinical in vivo evaluation 7.4 Clinical investigations
25	Annex A (informative) Rationale for the provisions of this part of ISO 5480
28	Annex B (normative) Packaging
29	Annex C (normative) Product labels, instructions for use, and training
32	Annex D (normative) Sterilization
33	Annex E (informative) In vitro test guidelines for paediatric devices
37	Annex F (informative) Statistical procedures when using in vitro performance criteria
38	Annex G (informative) Examples and definitions of some physical and material properties of heart valve systems
49	Annex H (informative) Examples of standards applicable to testing of materials and components of heart valve systems
55	Annex I (informative) Raw and post-conditioning mechanical properties for support structure materials
57	Annex J (informative) Corrosion assessment
60	Annex K (informative) Echocardiographic protocol
63	Bibliography

Status

Withdrawn

Title

Cardiovascular implants. Cardiac valve prostheses – General requirements

Publisher

BSI

Committee

CH/150/2

Pages

Publication Date

2015-10-31

Withdrawn Date

2021-02-08

Replaced By

BS EN ISO 5840-1:2021

ISBN

978 0 580 80484 7

Standard Number

BS EN ISO 5840-1:2015

Identical National Standard Of

ISO 5840-1:2015, EN ISO 5840-1:2015

Descriptors

Packaging, Performance, In vivo testing, Performance testing, Verification, Medical equipment, Heart, Risk assessment, Design, Labels, Circulatory system, Prosthetic devices, Hazards, Classification systems, Valves, Sterilization (hygiene), Cardiology, Life (durability), Acceptance (approval), Prosthesis, Instructions for use, Clinical testing, Reports, Physical properties of materials, Implants (surgical)

ICS Codes

11.040.40 - Implants for surgery, prosthetics and orthotics


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BS EN ISO 5840-1:2015

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