QUALITY SYSTEMS. MEDICAL DEVICES. PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002.
€62.00
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATIONN RESIDUALS. (ISO 10993-7:1995).
€106.00
BIOLOGICAL EVAULATION OF MEDICAL DEVICES. PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS. (ISO 10993-7:1995).
€0.00
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 10: TESTS FOR IRRITATION AND SENSIBILIZATION. (ISO 10993-10:1995).
€98.00
BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES. (ISO 10993-16:1997).
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002. (ISO 13488:1996)
€59.00
Air, water and difficult terrain ambulances. Part 1: Medical device interface requirements for the continuity of patient care.
€71.00
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
€58.00
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
€116.00
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
€73.00
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
€96.00
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
€125.00
Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
€60.00
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
