DIN EN ISO 13408-7:2015-11
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
German, English
01-01-2015
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National foreword
National Annex NA (informative) - Bibliography
European 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
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
Bibliography
This standard is included in DIN Handbook 406.
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| ISO 13408-7:2012 | Identical |
| EN ISO 13408-7:2015 | Identical |
| DIN EN ISO 13485:2016-08 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| 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 |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| DIN EN ISO 13408-1:2015-12 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| DIN EN ISO 11737-2:2010-04 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
| 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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