BS EN ISO 11607-1:2020
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Requirements for materials, sterile barrier systems and packaging systems
16-09-2022
20-01-2020
This document specifies 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.
| Committee |
CH/198
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| DocumentType |
Standard
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| ProductNote |
THIS STANDARD ALSO REFERS TO JIS T 0993-1,EDANA 170-1, JIS P-8124,JIS P-8111 Implementation of CEN correction notice 12 February 2020: European foreword updated with correct superseding information
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| PublisherName |
British Standards Institution
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| Status |
Withdrawn
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| Supersedes |
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
| Standards | Relationship |
| ISO 11607-1:2019 | Identical |
| EN ISO 11607-2:2020 | Identical |
| EN ISO 11607-1:2020 | Identical |
| EN ISO 11607-1:2017 | 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 |
| 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 |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| 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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