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  • ISO 13408-2:2003

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Aseptic processing of health care products Part 2: Filtration

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  05-09-2018

    Language(s):  English, French

    Published date:  26-03-2003

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.

    ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    I.S. EN ISO 22442-3:2007 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
    AAMI ISO 22442-3:2007 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
    AAMI ISO 13408-1 : 2008 : R2011 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    UNE-EN ISO 22442-1:2016 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    DIN EN ISO 22442-1:2016-05 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    BS EN ISO 14534:2015 Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
    ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
    I.S. EN 285:2015 STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS
    04/30090382 DC : DRAFT NOV 2004 ISO 13408-5 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: CLEANING IN PLACE
    DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    DIN EN ISO 13408-1:2015-12 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    AAMI ISO 22442-3 : 2007 : R2011 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
    BS EN ISO 13408-1:2015 Aseptic processing of health care products General requirements
    ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
    DIN EN 556-2:2015-11 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    DIN EN ISO 22442-3:2008-03 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
    BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated \'STERILE\' Requirements for aseptically processed medical devices
    BS EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Application of risk management
    I.S. EN ISO 14534:2015 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
    I.S. EN ISO 22442-1:2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT (ISO 22442-1:2015)
    EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
    09/30207531 DC : 0 BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
    07/30090385 DC : 0 ISO 13408-1 - ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 22442-1:2016 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT
    DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    DIN EN 285:2016-05 Sterilization - Steam sterilizers - Large sterilizers
    PREN ISO 14160 : DRAFT 2009 STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    09/30157765 DC : 0 BS EN ISO 14160 REV - STERILIZATION OF HEALTH CARE PRODUCTS - LIQUID CHEMICAL STERILIZING AGENTS FOR SINGLE-USE MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - REQUIREMENTS FOR CHARACTERIZATION, DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    AAMI ISO 13408-1 : 2008 : INC : AMD 1 : 2013 : R201100 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    AAMI ISO 13408-1:2008 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    I.S. EN ISO 13408-1:2015 ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    BS EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
    ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
    ISO 14534:2011 Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
    BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers
    UNE-EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
    EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    I.S. EN 556-2:2015 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
    ANSI/AAMI/ISO 13022:2012 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
    UNE-EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers
    EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
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