- Document number:ISO/TR 21582
- Issuing date:2021-07-01
- Document type:Technische Regel
- Title:Pyrogenicity - Principles and methods for pyrogen testing of medical devices
- Author:ISO/TC 194 Biological evaluation of medical devices
- Search term:Bioassay; Biological; Biological tests; CE marking; Certification; Checks; Conditions; Cytotoxicity; Definitions; Dental equipment; Dental instruments; Evaluations; Extraction; Extracts; Implants (surgical); Materials; Medical equipment; Medical products; Particles; Patterns; Preparation; Production; Pyrogen; Reference materials; References; Samples; Selection; Specification (approval); Specimen preparation; Surfaces; Surgical equipment; Surgical implants; Surgical instruments; Temperature; Test samples; Testing
- Application areas:09.01 Medizinprodukte im Allgemeinen
- Hazards:AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; BA Biologische Gefährdungen im Allgemeinen
- ICS:11.100.20 Biological evaluation of medical devices
- Price:115,90 EUR
- Identical with:PD ISO/TR 21582(2021-07-28)<IDT>; FD S99-513(2021-12-01)<IDT>; TSE ISO/TR 21582(2022-03-02)<IDT>
- Update flag:Unchanged
DE
EN