BS EN ISO 13408-7:2015
Current
The latest, up-to-date edition.
Aseptic processing of health care products Alternative processes for medical devices and combination products
Hardcopy , PDF
English
31-08-2015
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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.
| 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 |
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.
| 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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