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BS ISO 7198:1998

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Cardiovascular implants. Tubular vascular prostheses

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2017

Superseded by

BS EN ISO 7198:2017

Language(s)

English

Published date

15-10-1998

€306.17
Excluding VAT

1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Requirements for finished prosthesis
6 Requirements for in vivo preclinical and clinical
    evaluation
7 Sampling
8 Test methods for vascular prostheses
9 In vivo preclinical and clinical test methods for
    vascular prostheses
10 Information to be recorded and disclosed by the
    manufacturer on request

Defines requirements regarding testing, packaging, labelling and terminology for sterile tubular vascular prostheses for replacement, bypass or for forming shunts between segments of the vascular system in humans.

Committee
CH/150/2
DevelopmentNote
Supersedes 96/561667 DC. (07/2005)
DocumentType
Standard
Pages
50
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 7198:2016 Identical
ISO 7198:1998 Identical

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ISO 5081:1977 Textiles Woven fabrics Determination of breaking strength and elongation (Strip method)
ASTM D 76 : 1999 Standard Specification for Tensile Testing Machines for Textiles
ISO 472:2013 Plastics — Vocabulary
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice

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