04/30101215 DC : DRAFT APR 2004

Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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ISO 11607-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES

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Superseded date: 31-05-2006

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

Table of Contents - (Show below) - (Hide below)

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

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Comment Closes On
Committee	LBI/35/9
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11607-2 : 2006

Standards Referencing This Book - (Show below) - (Hide below)

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

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