Instructions for use for in vitro diagnostic instruments for self-testing.
€54.00
Stability testing of in vitro diagnostic reagents.
€53.00
Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
€75.00
€0.00
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2002)
€73.00
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2002/Amd 1:2006)
€50.00
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1 (ISO 10993-10:2002/Amd 1:2006)
€40.00
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS.
€61.00
REQUIREMENTS FOR MARKING OF IN VITRO DIAGNOSTIC INSTRUMENTS.
€47.00
IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.
IN VITRO DIAGNOSTIC MEDICAL DEVICES. INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY.
€69.00
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY. (ISO 10993-3:1992)
€59.00
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:92)
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 5: TEST FOR CYTOTOXICITY: IN VITRO METHODS. (ISO 10993-5:1992).