BS ISO 22679:2021

$215.11

Cardiovascular implants. Transcatheter cardiac occluders

Published By	Publication Date	Number of Pages
BSI	2021	82

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

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Description

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PDF Pages	PDF Title
2	undefined
7	Foreword
8	Introduction
9	1 Scope 2 Normative references
10	3 Terms and definitions
14	4 Abbreviations
15	5 Fundamental requirements 5.1 General 5.2 Risk management
16	6 Device description 6.1 General 6.2 Intended use 6.3 Design inputs 6.3.1 Operational principles and specifications 6.3.2 Functional, performance and safety requirements
17	6.3.3 Implant procedure: Device and usability requirements
18	6.3.4 Packaging, labelling and sterilization 6.4 Design outputs 6.5 Design transfer (manufacturing verification or validation) 7 Design verification and validation 7.1 General requirements
19	7.2 In vitro assessment 7.2.1 General 7.2.2 Test conditions, sample selection and reporting requirements
20	7.2.3 Material property assessment
21	7.2.4 Structural performance assessment
22	7.2.5 Component corrosion assessment 7.2.6 Visibility
23	7.2.7 Visual inspection 7.2.8 Dimensional verification 7.2.9 Device MRI compatibility 7.2.10 Simulated use assessment 7.2.11 Usability engineering process 7.2.12 Design- or procedure-specific testing 7.3 Preclinical in vivo evaluation 7.3.1 General 7.3.2 Overall requirements
25	7.3.3 Methods
26	7.3.4 Test report
27	7.4 Clinical investigations 7.4.1 General
28	7.4.2 Study considerations
29	7.4.3 Imaging assessment 7.4.4 Study design 7.4.5 Explant analysis
30	7.4.6 Pilot study considerations 7.4.7 Study endpoints 7.4.8 Ethical considerations
31	7.4.9 Pivotal studies: Distribution of subjects and investigators 7.4.10 Site qualification and training requirements 7.4.11 Study population
32	7.4.12 Statistical considerations
33	7.4.13 Sample size 7.4.14 Duration of study 7.4.15 Patient selection criteria
34	7.4.16 Clinical data requirements
39	Annex A (informative) Rationale for the provisions of this document
42	Annex B (informative) Transcatheter cardiac occluder hazard analysis example
44	Annex C (normative) Packaging
45	Annex D (normative) Product labels and instructions for use
46	Annex E (normative) Sterilization
47	Annex F (informative) Corrosion assessment
50	Annex G (informative) In vitro test guidelines for paediatric devices
52	Annex H (informative) Fatigue and durability assessment
58	Annex I (normative) Adverse event classification during clinical investigation
63	Annex J (informative) Imaging protocol
64	Annex K (informative) Clinical investigation endpoints for transcatheter cardiac occluders: Suggestions for endpoints and their timing
67	Annex L (informative) Examples of design specific testing
69	Annex M (informative) Guidelines for delivery system design evaluation
71	Annex N (normative) Preclinical in vivo evaluation
74	Annex O (informative) In vitro test pressure guidelines
76	Annex P (informative) Training for physicians and support staff
77	Bibliography

Additional information

Status	Definitive
Pages	82
Publication Date	2021-12-01
ISBN	978 0 580 51866 9
Standard Number	BS ISO 22679:2021
Title	Cardiovascular implants. Transcatheter cardiac occluders
Identical National Standard Of	ISO 22679
Descriptors	Cardiovascular system, Medical equipment, Surgical implants, Orthopaedic equipment, Surgical equipment, Implants (surgical)
Publisher	BSI
Committee	CH/150/2
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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BS ISO 22679:2021

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