ISO 10015 :1999 QUALITY MANAGEMENT - GUIDELINES FOR TRAINING ISO 10993.1-2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING ISO 10993.3-2003 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY. CARCINOGENICITY AND REPRODUCTIVE TOXICITY ISO 10993.5-1999 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR CYTOTOXICITY: IN VITRO METHODS ISO 10993.10-2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED-TYPE HYPERSENSITIVITY *** SEE ALSO ISO 10993 SET *** |
ISO 11135-1994 Medical devices-validation and routine control of ethylene oxide sterilization
ISO 11137-1 :2006 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT. VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 11137-1 :2006 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE
ISO 13485 :2003 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
ISO 14155-1 :2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES OF HUMAN SUBJECTS - PART1: GENERAL REQUIRMENTS
ISO 14155-2 :2003 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
ISO 14644-2 :2000 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: SPECIFICATIONS FOR TESTING AND MONITORING TO PROVE CONTINUED COMPLIANCE WITH ISO 14644-1
ISO 14971 :2003 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 15223 :2004 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS. LABELLING AND INFORMATION TO BE SUPPLIED
ISO 17511 :2003 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES INBIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS
ISO 188-1998 Rubber,vulcanized or thermoplastic-Accelerated ageing and heat resistance tests
ISO 2859-2 :1985 SAMPLING PROCEDURES FOR INSPECTION BY ATTRIBUTES
ISO 527-1 :1993 PLASTICS - DETERMINATION OF TENSILE PROPERTIES - PART 1: GENERAL PRINCIPLES
ISO 6874 :2005 DENTISTRY - POLYMER-BASED PIT AND FISSURE SEALANTS
ISO 7405 :1997 DENTISTRY - PRECLINICAL EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY - TEST METHODS FOR DENTAL MATERIALS
ISO 7886.1-1993 Sterile hypodermic syringes for single use
ISO 7886.2-1996 Sterile hypodermic syringes for single use
ISO 7886.3-2005 Sterile hypodermic syringes for single use
ISO 7886.4-2005 Sterile hypodermic syringes for single use
ISO 8536-4 :2007 INFUSION EQUIPMENT FOR MEDICAL EQUIPMENT - PART 4: INFUSION SETS FOR SINGLE USE. GRAVITY FEED
ISO 9919 -2005 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
