Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products

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Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

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English, French, Russian

Published date

31-07-2012

Publisher

International Organization for Standardization

ISO 13408-7:2012 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.

ISO 13408-7:2012 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.

Committee	ISO/TC 198
DevelopmentNote	Supersedes ISO/DIS 13408-7. (08/2012)
DocumentType	Standard
Pages	19
ProductNote	ISO 14644 AND ISO 14698 ALSO REFERS THIS STANDARD.
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
ANSI/AAMI/ISO 13408-7:2012(R2018)	Identical
NF EN ISO 13408-7 : 2015	Identical
NBN EN ISO 13408-7 : 2015	Identical
NEN EN ISO 13408-7 : 2015	Identical
NS EN ISO 13408-7 : 2015	Identical
I.S. EN ISO 13408-7:2015	Identical
PN EN ISO 13408-7 : 2015	Identical
SN EN ISO 13408-7:2015	Identical
UNI EN ISO 13408-7 : 2015	Identical
UNE-EN ISO 13408-7:2015	Identical
BS EN ISO 13408-7:2015	Identical
EN ISO 13408-7:2015	Identical
DIN EN ISO 13408-7:2015-11	Identical
DIN EN ISO 13408-7 E : 2015	Identical
NEN ISO 13408-7 : 2012	Identical
NF ISO 13408-7 : 2012	Identical
BS ISO 13408-7 : 2012	Identical

I.S. EN ISO 13408-2:2018	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION (ISO 13408-2:2018)
ISO 18362:2016	Manufacture of cell-based health care products Control of microbial risks during processing
UNE-EN ISO 22442-1:2016	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
ISO 13408-2:2018	Aseptic processing of health care products — Part 2: Sterilizing filtration
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)
DIN ISO 13022 E : 2014	MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
14/30266295 DC : 0	BS ISO 18362 - PROCESSING OF CELL-BASED HEALTH CARE PRODUCTS
EN ISO 13408-2:2018	Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
AAMI ISO 13408-2 : 2003 : R2013	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
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
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 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)
PREN 556-2 : DRAFT 2014	STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
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)
AAMI ISO 13408-2 : 2003	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 2: STERILIZING FILTRATION
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
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
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
14/30273161 DC : 0	BS EN 556-2 - STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED ''STERILE'' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES

ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO 11137-2:2013	Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 14971:2007	Medical devices Application of risk management to medical devices

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ISO 13408-7:2012

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