11.100.20 标准查询与下载
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This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices.
Clinical investigation of medical devices for human subjects - Clinical investigation plans
- ICS
- 11.100.20
- CCS
- C05
- 发布
- 2003-05-27
- 实施
- 2003-05-27
This part of EN ISO 14155 provides requirements for the preparation of a Clinical Investigation Plan (CIP) for the clinical investigation of medical devices. The compilation of a CIP in accordance with the requirements of this standard and adherence to it will help in optimising the scientific validity and reproducibility of the results of a clinical investigation. This Standard does not apply to in vitro diagnostic medical devices.
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2003-05
- 实施
ISO 10993-17:2002 specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. ISO 10993-17:2002 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. ISO 10993-17:2002 does not address the potential for exposure from such sources.
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2003-04-30
- 实施
- 2003-04-30
ISO 14155-1:2002 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to: protect human subjects; ensure the scientific conduct of the clinical investigation; assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. ISO 14155-1:2002 specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. ISO 14155-1:2002 is not applicable to in vitro diagnostic medical devices.
Clinical investigation of medical devices for human subjects - General requirements
- ICS
- 11.100.20
- CCS
- C05
- 发布
- 2003-03-12
- 实施
- 2003-03-12
This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to — protect human subjects, — ensure the scientific conduct of the clinical investigation, — assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This part of ISO 14155 a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device, b) specifies requirements for the organization, conduct, monitoring, data collection and documentation of the clinical investigation of a medical device, c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects. This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.
Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2003-02
- 实施
Specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification, together with guidance on the analysis of these solutions in order to identify degradation products. This Standards considers only those degradation products generated by a chemical dissociation of ceramics during in-vitro testing.
Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Supersedes EN 30993-3: 1999; ISO 10993-3: 2003
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Specifies general requirements for evaluating the interactions of medical devices with blood. This Standard describes a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Biological evaluation of medical devices - Selection of tests for interactions with blood
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Specifies allowable limits for residual ethylene oxide and ethylene chlorohydrin in individual ethylene oxide sterilized medical devices, procedures for the measurement of ethylene oxide and ethylene chlorohydrin, and methods for determining compliance so that devices may be released.
Biological evaluation of medical devices - Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Specifies requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. This Standard also specifies the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference materials as experimental controls.
Biological evaluation of medical devices - Selection and qualification of reference materials for biological tests
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitvity, including pretest considerations, details of the test procedures, and key factors for the interpretation of the results.
Biological evaluation of medical devices - Tests for irritation and delayed type hypersensitivity
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
Specifies guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. This Standard is only applicable to those degradation products generated by chemical alteration of the finished metallic device in an in-vitro accelerated degradation test.
Biological evaluation of medical devices - Identification and quantification of degradation products from metals and alloys
- ICS
- 11.100.20
- CCS
- 发布
- 2003
- 实施
This part of ISO 10993 specifies a method for the determination of allowable limits for substances teachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food,, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2002-12
- 实施
This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the ISO 10993 series. Specifically, this part of ISO 10993 addresses: — test material selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of and requirements for reference materials; and — preparation of extracts. The applicability of this part of ISO 10993 to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2002-12
- 实施
This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
Biological evaluation of medical devices - Selection of tests for interactions with blood
- ICS
- 11.100.20
- CCS
- C04
- 发布
- 2002-11-14
- 实施
- 2002-11-14
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes pretest considerations, details of the test procedures, and key factors for the interpretation of the results. Guidance is given in annex A for the preparation of materials specifically in relation to the above tests. Guidance on the conduct of supplementary tests which are required specifically for devices used intradermally and in the ocular area is given in annex B. Guidance on the conduct of supplementary tests which may be required for devices used for oral, rectal, penile and vaginal areas is given in annex C.
Biological evaluation of medical devices - Tests for irritation and delayed-type hypersensitivity
- ICS
- 11.100.20
- CCS
- C04
- 发布
- 2002-10-08
- 实施
- 2002-10-08
This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical and dental devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2002-10
- 实施
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and delayed-type hypersensitivity. This part of ISO 10993 includes a) pretest considerations, b) details of the test procedures, and c) key factors for the interpretation of the results. Instructions are given in annex A for the preparation of materials specifically in relation to the above tests. Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile and vaginal areas are given in annex B.
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2002-09
- 实施
Specifies the requirements for tests of genotoxicity, carcinogenicity and reproductive toxicity for biological evaluation of medical devices.
Biological evaluation of medical devices - Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ICS
- 11.100.20
- CCS
- 发布
- 2002
- 实施
Specifies test methods for the assessment of the local effects of an implant material on living tissue.
Biological evaluation of medical devices - Tests for local effects after implantation
- ICS
- 11.100.20
- CCS
- 发布
- 2002
- 实施
