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CSA ISO 11607-1 : 2016

CSA ISO 11607-1 : 2016

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS

Available format(s)

Hardcopy , PDF

Withdrawn date

07-31-2021

Language(s)

English, French

Published date

01-01-2016

Publisher

Canadian Standards Association

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials and preformed sterile barrier systems
6 Design and development requirements for packaging
  systems
7 Information to be provided
Annex A (informative) - Guidance on medical
        packaging
Annex B (informative) - Standardized test methods
        and procedures that may be used to
        demonstrate compliance with the requirements
        of this part of ISO 11607
Annex C (normative) - Test method for resistance
        of impermeable materials to the passage of air
Bibliography

Defines the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

DocumentType
Standard
Pages
58
PublisherName
Canadian Standards Association
Status
Withdrawn

Standards Relationship
ISO 11607-1:2006 Identical

CAN/CSA-Z314-18 Canadian medical device reprocessing

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
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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
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 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
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
ISO 186:2002 Paper and board — Sampling to determine average quality
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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Hardcopy - English
PDF - English
Hardcopy - French
PDF - French
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