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ISO - 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 - SECOND EDITION Organization: ISO
Date: 2009-10-15
Description: Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
SNV - SN EN 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 Organization: SNV
Date: 2010-03-01
Description: Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
AAMI 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 Organization: AAMI
Date: 2009-01-01
Description: Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
CSA 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 - SECOND EDITION Organization: CSA
Date: 2011-01-01
Description: Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices.
DS/ISO/TS 19930 - GUIDANCE ON ASPECTS OF A RISK-BASED APPROACH TO ASSURING STERILITY OF TERMINALLY STERILIZED, SINGLE-USE HEALTH CARE PRODUCT THAT IS UNABLE TO WITHSTAND PROCESSING TO ACHIEVE MAXIMALLY A STERILITY ASSURANCE LEVEL OF 10-6 Organization: DS
Date: 2017-11-27
Description: NOTE – It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.
ISO - ISO TS 19930 - GUIDANCE ON ASPECTS OF A RISK-BASED APPROACH TO ASSURING STERILITY OF TERMINALLY STERILIZED, SINGLE-USE HEALTH CARE PRODUCT THAT IS UNABLE TO WITHSTAND PROCESSING TO ACHIEVE MAXIMALLY A STERILITY ASSURANCE LEVEL OF 10−6 - FIRST EDITION Organization: ISO
Date: 2017-12-01
Description: NOTE It is not a requirement of the International Standards for development, validation and routine control of a sterilization process to have a full quality management system. Attention is drawn to the standard for quality management systems (see ISO 13485) that controls all stages of the lifecycle of health care product.

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