04/30101211 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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 11607-1 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

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Superseded date: 31-05-2006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 General
  4.2 Quality systems
  4.3 Test methods
  4.4 Documentation
5 Material and preformed sterile barrier systems
  5.1 General requirements
  5.2 Microbial barrier properties
  5.3 Compatibility with the sterilization process
  5.4 Compatibility with the labelling system
  5.5 Storage and transport
6 Design and development requirements for packaging systems
  6.1 General
  6.2 Design
  6.3 Packaging system performance testing
  6.4 Stability testing
Annex A (informative) Guidance on medical packaging
      A.1 Factors influencing the choice of the materials and design
          of the packaging system
      A.2 Sterilization processes and considerations
      A.3 Sterile barrier systems
Annex B (informative) Standardized test methods and procedures
        that may be used to demonstrate compliance with requirements
        of ISO 11607-1
      B.1 General
      B.2 Packaging materials and preformed sterile barrier systems
      B.3 Sterile barrier systems
Annex C (normative) Test method for resistance of impermeable
        materials to passage of air
Bibliography
Annex ZA (informative) Relationship between this International
         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Status	Superseded
Superseded By	BS EN ISO 11607-1 : 2009

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 550 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015	Sterilization - Steam sterilizers - Large sterilizers
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
EN 868-4:2017	Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
EN 868-1 : 1997	PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
EN 868-6:2017	Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
ISO 5636-1:1984	Paper and board Determination of air permeance (medium range) Part 1: General method
EN 868-2:2017	Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-3:2017	Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
AAMI ST65:2008(R2018)	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
ISO 5636-2:1984	Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method
ISO 5636-5:2013	Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
EN 552:1994/A2:2000	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 186:2002	Paper and board — Sampling to determine average quality
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 9001:2015	Quality management systems — Requirements
ISO 11134:1994	Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
EN 868-7:2017	Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
ISO 13683:1997	Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
EN 1422:2014	Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 554 : 1994	STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

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