04/30101215 DC : DRAFT APR 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
31-05-2006
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Sampling
4.3 Test methods
4.4 Documentation
5 Validation of packaging processes
5.1 General
5.2 Installation qualification (IQ)
5.3 Operational qualification (OQ)
5.4 Performance qualification (PQ)
5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid path
Annex A (informative) Process development
Bibliography
Annex ZA (informative) Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
| Committee |
LBI/35/9
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| EN 13795-1:2002+A1:2009 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products |
| EN 868-5:2009 | Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 868-6:2017 | Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods |
| AAMI ST65:2008(R2018) | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
| ISO 186:2002 | Paper and board — Sampling to determine average quality |
| ISO/TS 11139:2006 | Sterilization of health care products Vocabulary |
| DIN 58953-8:2010-05 | STERILIZATION - STERILE SUPPLY - PART 8: LOGISTICS OF STERILE MEDICAL DEVICES |
| ISO 9001:2015 | Quality management systems — Requirements |
| AAMI ST33 : 2ED 96 | GUIDELINES FOR THE SELECTION AND USE OF REUSABLE RIGID CONTAINER SYSTEMS FOR ETHYLENE OXIDE STERILIZATION AND STEAM STERILIZATION IN HEALTH CARE FACILITIES |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| DIN 58953-7:2010-05 | STERILIZATION - STERILE SUPPLY - PART 7: USE OF STERILIZATION PAPER, NONWOVEN WRAPPING MATERIAL, TEXTILE MATERIALS, PAPER BAGS AND SEALABLE POUCHES AND REELS |
| DIN 58953-9:2010-05 | Sterilization - Sterile supply - Part 9: Use of sterilization container |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.