Standard

ISO 14155:1996

Feb 1996 Withdrawn

Note: This standard has a draft: ISO 14155:2026

Corrigenda and amendments are bought separately.

Language English

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Abstract

Pertains to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment. Specifies the requirements for conducting the clinical investigation and documentation. Provides the framework for systematic written procedures for the organization, design, implementation and data collection.

Document information

Standard from ISO
Published: 29 February 1996
Withdrawn: 26 February 2003
Expires: 17 November 1994
Edition: 1
Version: 1
Document type: IS
ISBN:

ICS 11.100
ISO TC ISO/TC 194

Product Relations

Revised by: ISO 14155-2:2003
Revised by: ISO 14155-2:2003
Revised by: ISO 14155-2:2003
Revised by: ISO 14155-1:2003
Revised by: ISO 14155-1:2003
Revised by: ISO 14155-1:2003

ISO 14155:1996

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ISO 14155:2026

ISO 14155:2020

ISO 14155:2020

ISO 14155:2020

ISO 14155:2011

ISO 14155:2011

ISO 14155:2011

ISO 14155:1996

Abstract

Document information

Product Relations

Product life cycle

Access to standards for the entire organization

Benefits of our business solution:

Contact us today for a non-binding offer

Extended editions Extended editions (0)

Version history Related corrigendum and amendments (0)

Version history History (8)

ISO 14155:2026

ISO 14155:2020

ISO 14155:2020

ISO 14155:2020

ISO 14155:2011

ISO 14155:2011

ISO 14155:2011

ISO 14155:1996

Abstract

Document information

Product Relations

Product life cycle