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UNI EN ISO 14155 : 2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
Superseded date

09-01-2022

Published date

01-01-2012

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Ethical considerations
5 Clinical investigation planning
6 Clinical investigation conduct
7 Suspension, termination and close-out of the clinical
  investigation
8 Responsibilities of the sponsor
9 Responsibilities of the principal investigator
Annex A (normative) - Clinical investigation plan (CIP)
Annex B (normative) - Investigator's brochure (IB)
Annex C (informative) - Case report forms (CRFs)
Annex D (informative) - Clinical investigation report
Annex E (informative) - Essential clinical investigation
        documents
Annex F (informative) - Adverse event categorization
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices

Describes good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

DevelopmentNote
Supersedes UNI EN ISO 14155-1 and UNI EN ISO 14155-2. (05/2011)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN ISO 14155:2011/AC:2011 Identical
ISO 14155:2011 Identical

ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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