11.100.20 标准查询与下载
共找到 323 条与 相关的标准，共 22 页
Dieser Teil der ISO 10993 legt spezifische Strategien fur die Risikoabschatzung, die Auswahl der Prufverfahren zur Gefahrenerkennung und das Risikomanagement fest, unter Berucksichtigung der Moglichkeit, der nachfolgenden, potenziellen irreversiblen biologischen Effekte, die als Ergebnis der Exposition durch Medizinprodukte auftreten konnen: Genotoxizitat; Karzinogenitat; Reproduktions- und Entwicklungstoxizitat. Dieser Teil der ISO 10993 ist anwendbar, sobald die Notwendigkeit festgestellt wurde, ein Medizinprodukt auf potenzielle Genotoxizitat, Karzinogenitat oder Reproduktionstoxizitat zu untersuchen. ANMERKUNG Eine Anleitung zur Auswahl der Prufungen ist in ISO 10993-1 enthalten.
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-10
- 实施
BS ISO 16782. Clinical laboratory testing. Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
- ICS
- 11.100.20
- CCS
- 发布
- 2014-06-26
- 实施
- 2014-06-26
Biological evaluation of medical devices. Tests for irritation and skin sensitization
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2014-02-28
- 实施
- 2014-02-28
Clinical investigation. Good clinical practice
- ICS
- 11.100.20
- CCS
- 发布
- 2014
- 实施
- 2015-06-01
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
- ICS
- 11.100.20
- CCS
- 发布
- 2013-12-16
- 实施
- 2013-12-16
Dieser Teil der ISO 10993 beschreibt das Verfahren fur die Beurteilung von Medizinprodukten und ihren Bestandteilen hinsichtlich ihres Potentials, eine Irritation und eine Hautsensibilisierung hervorzurufen. Dieser Teil der ISO 10993 enthalt: a) vor der Prufung durchzufuhrende Uberlegungen hinsichtlich einer Irritation, einschlieslich In-silico- und In-vitro-Verfahren zur dermalen Exposition; b) Einzelheiten zur Durchfuhrung von In-vivo-Prufungen (Irritation und Sensibilisierung); c) Schlusselfaktoren fur die Interpretation der Ergebnisse. Anhang A enthalt Anweisungen fur die spezielle Vorbereitung von Materialien im Zusammenhang mit den vorstehend angefuhrten Prufungen. In Anhang B sind mehrere spezielle Prufungen auf Irritation bei der Anwendung von Medizinprodukten in anderen Bereichen als der Haut beschrieben.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2013-08
- 实施
Biological evaluation of medical devices. Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2012-10-31
- 实施
- 2012-10-31
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012); German version EN ISO 10993-12:2012
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2012-10-01
- 实施
Biological evaluation of medical devices - Part 12 : sample preparation and reference materials.
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2012-09-01
- 实施
- 2012-09-08
ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of IS
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- 发布
- 2012-08-24
- 实施
- 2012-08-24
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-07
- 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 device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically, this part of ISO 10993 addresses the following: — test sample selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of, and requirements, for reference materials; — preparation of extracts. This part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-07
- 实施
Guide to European Medical Device Trials and BS EN ISO 14155
- ICS
- 11.100.20
- CCS
- C90
- 发布
- 2012-06-13
- 实施
- 2012-06-13
This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products, biologics, medical devices and active implantable medical devices, or combinations thereof. It covers viable human materials of autologous as well as allogeneic human origin, obtained from living or deceased donors. For manufacturers of medical products containing viable cells of human origin, this International Standard specifies procedures to be used in processing and handling, as well as those to be used in identifying the hazards and hazardous situations associated with such cells, in order to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, this International Standard outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk and expected medical benefit as compared to available alternatives. This International Standard provides requirements and guidance on risk management related to the hazards typical of medical products manufactured utilizing viable human materials, such as: a) contamination by bacteria, moulds, yeasts or parasites; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) contaminating material responsible for undesired pyrogenic, immunological or toxicological reactions; e) decomposition of the product and degradation products caused by inadequate handling; f) hazards related to the tumorigenic potential of the cell types used; g) complications resulting from unintended physiological and anatomical consequences (this includes unintended migration of cells, unwanted release of biologically active substances such as hormones and cytokines, and unintended interactions between cellular and non-cellular components of the product); h) failure of traceability; i) complications resulting from the material eliciting an unintended immunogenic reaction. For the evaluation of contamination with other unclassified pathogenic entities, similar principles might be applicable. Hazards related to genetic modification are outside the scope of this International Standard and are addressed elsewhere. NOTE 1 A definition of “genetically modified” can be found in ASTM F2312. NOTE 2 This International Standard does not specify a quality management system for the control of all stages of production of medical products as described above. If additional national or regional criteria beyond what is defined in this International Standard exist in the country where the medical product will be used, they are also applicable. NOTE 3 Regional requirements can be more stringent than requirements referenced in this International Standard, especially with regard to donor eligibility criteria. This International Standard is not applicable to: — non-viable materials of human origin; 1 — viable cells of non-human origin; — blood and its components used for transfusion, germ cells, organs and bone marrow used for transplantation, and other tissues that do not meet the definition of “medical product”; — in vitro diagnostic devices. NOTE 4 For guidance on the application of this International Standard, see Annex A.
Medical products containing viable human cells - Application of risk management and requirements for processing practices
- ICS
- 11.100.20
- CCS
- C01
- 发布
- 2012-04
- 实施
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-03-01
- 实施
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2012-01
- 实施
Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
- ICS
- 11.100.20
- CCS
- C37
- 发布
- 2011-07
- 实施
Clinical investigation of medical devices for human subjects. Good clinical practice
- ICS
- 11.100.20
- CCS
- C05
- 发布
- 2011-02-28
- 实施
- 2011-02-28
This International Standard addresses 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. The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations. This International Standard specifies general requirements intended to ⎯ protect the rights, safety and well-being of human subjects, ⎯ ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, ⎯ define the responsibilities of the sponsor and principal investigator, and ⎯ assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. It does not apply to in vitro diagnostic medical devices. NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.
Clinical investigation of medical devices for human subjects - Good clinical practice
- ICS
- 11.100.20
- CCS
- C30
- 发布
- 2011-02-01
- 实施
- 2011-02-01
