BS EN ISO 13485 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR REGULATORY PURPOSES

BS EN ISO 13485 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR REGULATORY PURPOSES

Latest Version 2003 COR 2010 31/01/2010 (DD/MM/YYYY)
Language ENGLISH
Publisher BSI
Referenced Standards

90/385/EEC COUNCIL DIRECTIVE OF 20 JUNE 1990 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES
93/42/EEC COUNCIL DIRECTIVE 93/42/EEC OF 14 JUNE 1993 CONCERNING MEDICAL DEVICES
EN 13641 ELIMINATION OR REDUCTION OF RISK OF INFECTION RELATED TO IN VITRO DIAGNOSTIC REAGENTS
ISO 10012 MEASUREMENT MANAGEMENT SYSTEMS – REQUIREMENTS FOR MEASUREMENT PROCESSES AND MEASURING EQUIPMENT
ISO 11134 STERILIZATION OF HEALTH CARE PRODUCTS – REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL – INDUSTRIAL MOIST HEAT STERILIZATION
ISO 11135 MEDICAL DEVICES – VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 11137 STERILIZATION OF HEALTH CARE PRODUCTS – REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL – RADIATION STERILIZATION
ISO 13683 STERILIZATION OF HEALTH CARE PRODUCTS – REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL OF MOIST HEAT STERILIZATION IN HEALTH CARE FACILITIES
ISO 14155-1 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS – PART 1: GENERAL REQUIREMENTS
ISO 14155-2 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS – PART 2: CLINICAL INVESTIGATION PLANS
ISO 14160 STERILIZATION OF SINGLE-USE MEDICAL DEVICES INCORPORATING MATERIALS OF ANIMAL ORIGIN – VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY LIQUID STERILANTS
ISO 14937 STERILIZATION OF HEALTH CARE PRODUCTS – GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 14971 MEDICAL DEVICES – APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
ISO 19011 GUIDELINES FOR QUALITY AND/OR ENVIRONMENTAL MANAGEMENT SYSTEMS AUDITING
ISO 9000 QUALITY MANAGEMENT SYSTEMS – FUNDAMENTALS AND VOCABULARY
ISO 9001 QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS
ISO TR 14969 MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – GUIDANCE ON THE APPLICATION OF ISO 13485:2003
98/79/EEC
International Classification

03.120.10 – Quality management and quality assurance
11.020 – Medical sciences and health care facilities in general * IT application on health care technology, see 35.240.80
11.040.01 – Medical equipment in general

Incoming search terms:

• iso 11134
• bs en 13485
• iso11134
• iso standard for sterilization of medical devices
• ISO 13485 Equipment Requirements
• iso 13485 and process measurement
• iso 11134 free download
• free iso 11134
• en iso 13485 stands for
• bs in quality management