• Shopping Cart
    There are no items in your cart

BS EN ISO 14155:2011

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Clinical investigation of medical devices for human subjects. Good clinical practice

Available format(s)

Hardcopy , PDF

Superseded date

19-08-2020

Superseded by

BS EN ISO 14155:2020

Language(s)

English

Published date

30-09-2011

€303.84
Excluding VAT

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.

Committee
CH/194
DevelopmentNote
Supersedes BS EN ISO 14155-1, BS EN ISO 14155-2 and 08/30116059 DC. (02/2011)
DocumentType
Standard
Pages
70
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 14155:2011 Identical
EN ISO 14155:2011 Identical
ISO 14155:2011/Cor 1:2011 Identical

BS 70000:2017 Medical physics, clinical engineering and associated scientific services in healthcare. Requirements for quality, safety and competence
BIP 0113 : 2012 GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155

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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.