a) is applicable to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment;
b) specifies the requirements for the conduct of the clinical investigation and documentation on whether the medical device achieves the performance intended by the sponsor, determines any undesirable side effects under normal conditions of use and permits assessment of the acceptable risks relating to the intended performance of the device;
c) provides the framework for systematic written procedures for the organization, design, implementation, data collection, documentation arid conduct of the clinical investigation.
2 Normative references
The following standards contain provisions which, through reference in this standard, constitute provisions of this standard. At time of publication, the editions indicated were valid. All standards are subject to revision, and all parties using this standard are encouraged to investigate the possibility of applying the latest editions of the following standards.
World Medical Association's Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects (see Annex A).
3 Definitions
For the purposes of this standard, the following definitions apply.
3.1
clinical investigation
any systematic study in subjects undertaken to verify the performance of a specific device under normal conditions of intended use
3.2
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
——diagnosis, prevention, monitoring, treatment or alleviation of disease;
——diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;
——investigation, replacement or modification of the anatomy or of a physiological process;
——control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
3.3
device (intended for clinical investigation)
any medical device intended for use by an appropriately qualified practitioner when conducting clinical investigations in an adequate clinical environment
3.4
clinical performance
effects achieved by a device in relation to its intended use, when correctly applied to appropriate subjects
3.5
clinical investigation plan
principal document which includes detailed information on the rationale, including risk versus benefit analysis, objectives, design and proposed analyses, methodology and conduct of the clinical investigation
Foreword i ISO foreword ii 1 Scope 2 Normative references 3 Definitions 4 Ethical considerations 5 Basic requirements 6 Methodology 7 Presentation of results Annex A (Normative) World Medical Association Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects Annex B (Informative) Rationale Annex C (Informative) Flow chart for clinical investigation of medical devices
Clinical investigation of medical devices
1 Scope
This standard
a) is applicable to the clinical investigation in human subjects of those medical devices whose clinical performance needs assessment;
b) specifies the requirements for the conduct of the clinical investigation and documentation on whether the medical device achieves the performance intended by the sponsor, determines any undesirable side effects under normal conditions of use and permits assessment of the acceptable risks relating to the intended performance of the device;
c) provides the framework for systematic written procedures for the organization, design, implementation, data collection, documentation arid conduct of the clinical investigation.
2 Normative references
The following standards contain provisions which, through reference in this standard, constitute provisions of this standard. At time of publication, the editions indicated were valid. All standards are subject to revision, and all parties using this standard are encouraged to investigate the possibility of applying the latest editions of the following standards.
World Medical Association's Declaration of Helsinki, Recommendations guiding physicians in biomedical research involving human subjects (see Annex A).
3 Definitions
For the purposes of this standard, the following definitions apply.
3.1
clinical investigation
any systematic study in subjects undertaken to verify the performance of a specific device under normal conditions of intended use
3.2
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
——diagnosis, prevention, monitoring, treatment or alleviation of disease;
——diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;
——investigation, replacement or modification of the anatomy or of a physiological process;
——control of conception;
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
3.3
device (intended for clinical investigation)
any medical device intended for use by an appropriately qualified practitioner when conducting clinical investigations in an adequate clinical environment
3.4
clinical performance
effects achieved by a device in relation to its intended use, when correctly applied to appropriate subjects
3.5
clinical investigation plan
principal document which includes detailed information on the rationale, including risk versus benefit analysis, objectives, design and proposed analyses, methodology and conduct of the clinical investigation
Contents of YY/T 0297-1997
Foreword i
ISO foreword ii
1 Scope
2 Normative references
3 Definitions
4 Ethical considerations
5 Basic requirements
6 Methodology
7 Presentation of results
Annex A (Normative) World Medical Association Declaration of Helsinki: Recommendations guiding physicians in biomedical research involving human subjects
Annex B (Informative) Rationale
Annex C (Informative) Flow chart for clinical investigation of medical devices
