I.S. EN ISO 13408-7:2015
Current
The latest, up-to-date edition.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 7: ALTERNATIVE PROCESSES FOR MEDICAL DEVICES AND COMBINATION PRODUCTS (ISO 13408-7:2012)
Hardcopy , PDF
English
01-01-2015
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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European foreword
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
Defines 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.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| 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 14971:2007 | Medical devices Application of risk management to medical devices |
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