Aseptic processing of health care products Alternative processes for medical devices and combination products

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-08-2015

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Aseptic process definition
6 Manufacturing environment
7 Equipment
8 Personnel
9 Manufacture of the product
10 Process simulation
11 Test for sterility
Annex A (informative) - Risk assessment for aseptic
        processing - Quality risk management method
Annex B (informative) - Selection of a sample for testing
        for microbial contamination
Annex C (informative) - Testing options for process
        simulation
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         90/385/EEC on active implantable medical devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         93/42/EEC on medical devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU Directive
         98/79/EC on in vitro diagnostic medical devices

Describes 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 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	CH/198
DevelopmentNote	Renumbers and supersedes BS ISO 13408-7. 2015 version incorporates corrigendum to BS ISO 13408-7. (08/2015)
DocumentType	Standard
Pages	32
PublisherName	British Standards Institution
Status	Current
Supersedes	BS ISO 13408-7 : 2012

Standards	Relationship
ISO 13408-7:2012	Identical
EN ISO 13408-7:2015	Identical

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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BS EN ISO 13408-7:2015

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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