BS EN ISO 11607-2 : 2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES
Hardcopy , PDF
05-15-2018
English
01-01-2006
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Validation of packaging processes
6 Packaging system assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
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
Defines the requirements for development and validation of processes for packaging medical devices that are terminally sterilized, it includes forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 04/30101215 DC (05/2006) Supersedes 14/30255138 DC. 2006 Edition Re-issued in September 2014 & incorporates AMD 1 2014. (09/2014)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 11607-2:2017 & LC:2017 | Identical |
| DIN EN ISO 11607-2:2014-11 | Identical |
| NS EN ISO 11607-2 : 2017 | Identical |
| NBN EN ISO 11607-2 : 2006 AMD 1 2014 | Identical |
| UNE-EN ISO 11607-2:2017 | Identical |
| EN ISO 11607-2:2017 | Identical |
| ISO 11607-2:2006 | Identical |
| UNI EN ISO 11607-2 : 2014 | Identical |
| ONORM EN ISO 11607-2 : 2018 | Identical |
| NF EN ISO 11607-2 : 2018 | Identical |
| SN EN ISO 11607-2 : 2018 | Identical |
| NEN EN ISO 11607-2 : 2017 + COR 2017 | Identical |
| 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 |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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 |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| 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 |
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