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AAMI ISO 11607-2 : 2006 : R2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING, AND ASSEMBLY PROCESSES
Available format(s)

Hardcopy , PDF

Superseded date

23-09-2019

Language(s)

English

Published date

01-01-2010

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 11607-2:2006
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 packaging
Annex A (informative) Process development
Bibliography

Describes the requirements for development and validation of processes for packaging medical devices that are terminally sterilized.

Committee
ST/WG 07
DevelopmentNote
Supersedes AAMI ISO 11607 (05/2006)
DocumentType
Standard
Pages
26
ProductNote
Reconfirmed 2010
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11607-2:2006 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
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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$201.34
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