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BS EN ISO 13408-7 : 2015
M00017109
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BS EN ISO 13408-7 : 2015
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS
British Standards Institution
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Table of Contents
Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Quality system elements<br>5 Aseptic process definition<br>6 Manufacturing environment<br>7 Equipment<br>8 Personnel<br>9 Manufacture of the product<br>10 Process simulation<br>11 Test for sterility<br>Annex A (informative) - Risk assessment for aseptic<br> processing - Quality risk management method<br>Annex B (informative) - Selection of a sample for testing<br> for microbial contamination<br>Annex C (informative) - Testing options for process<br> simulation<br>Bibliography<br>Annex ZA (informative) - Relationship between this European <br> Standard and the Essential Requirements of EU Directive<br> 90/385/EEC on active implantable medical devices<br>Annex ZB (informative) - Relationship between this European<br> Standard and the Essential Requirements of EU Directive<br> 93/42/EEC on medical devices<br>Annex ZC (informative) - Relationship between this European<br> Standard and the Essential Requirements of EU Directive<br> 98/79/EC on in vitro diagnostic medical devices
Abstract
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.
General Product Information
| Document Type | Standard |
| Status | Current |
| Publisher | British Standards Institution |
| Committee | CH/198 |
| Supersedes |
|