ISO 13408-2:2003

Withdrawn

View Superseded by

Aseptic processing of health care products Part 2: Filtration

Available format(s)

Hardcopy , PDF 1 User , 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Withdrawn date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

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).

DocumentType	Standard
Pages	11
PublisherName	International Organization for Standardization
Status	Withdrawn
SupersededBy	ISO 13408-2:2018

Standards	Relationship
ONORM EN ISO 13408-2 : 2011	Identical
AAMI ISO 13408-2 : 2003 : R2013	Identical
SN EN ISO 13408-2 : 2011	Identical
GOST R ISO 13408-2 : 2007	Identical
UNE-EN ISO 13408-2:2011	Identical
UNI EN ISO 13408-2 : 2011	Identical
NBN EN ISO 13408-2 : 2011	Identical
DIN EN ISO 13408-2:2011-09	Identical
AAMI ISO 13408-2 : 2003	Identical
NS EN ISO 13408-2 : 2018	Identical
BS EN ISO 13408-2:2011	Identical
NEN EN ISO 13408-2 : 2011	Identical
PN EN ISO 13408-2 : 2012	Identical
NF EN ISO 13408-2 : 2011	Identical

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)