UNI EN ISO 13408-3 : 2011
Current
The latest, up-to-date edition.
ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 3: LYOPHILIZATION
15-09-2011
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality system elements
5 Product definition
6 Process definitions
7 User requirements
8 Validation
9 Routine monitoring and control
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
Describes requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process.
| Committee |
CT 44
|
| DevelopmentNote |
Supersedes UNI EN 13824. (10/2011)
|
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 13408-3:2006 | Identical |
| EN ISO 13408-3:2011 | Identical |
| ISO 13408-4:2005 | Aseptic processing of health care products — Part 4: Clean-in-place technologies |
| CFR 21(PTS200-299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299 |
| 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/TS 11139:2006 | Sterilization of health care products Vocabulary |
| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 13408-5:2006 | Aseptic processing of health care products Part 5: Sterilization in place |
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