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ISO 18362:2016

Current
Current

The latest, up-to-date edition.

Manufacture of cell-based health care products Control of microbial risks during processing
Amended by

ISO 18362:2016/Amd 1:2022

Available format(s)

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

Language(s)

English

Published date

15-01-2016

Publisher

International Organization for Standardization

ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'.

ISO 18362:2016 is not applicable to:

- procurement and transport of cell-based starting material used in processing of a CBHP,

- cell banking,

- control of genetic material,

- control of non-microbial product contamination,

- in vitro diagnostics (IVDs), or

- natural medicines.

EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids.

ISO 18362:2016 does not define biosafety containment requirements.

ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

DevelopmentNote
Supersedes ISO/DIS 18362. (01/2016)
DocumentType
Standard
Pages
32
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
DS ISO 18362 : 2016 Identical
NEN ISO 18362 : 2016 Identical
BS ISO 18362:2016 Identical
ABNT NBR ISO 18362:2023 Identical

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ISO 13408-7:2012 Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
ISO 14160:2011 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
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 13408-2:2003 Aseptic processing of health care products Part 2: Filtration
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 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
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 25424:2009 Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO 13408-1:2008 Aseptic processing of health care products — Part 1: General requirements
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 29463-1:2017 High efficiency filters and filter media for removing particles from air Part 1: Classification, performance, testing and marking
ISO 14644-4:2001 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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