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en-iso-11607-1-packaging-for-terminally-sterilized-medical-devices-requirements
Sterility and Microbial Limit Testing 21 CFR Part 211.113 Control of Microbiological Contamination21 CFR Part 211.165 Testing and Release for Distribution21 CFR Part 211.167 Special Testing RequirementsAOAC 2003.01 Testing for Escherichia coli and ColiformsAOAC 2003.07 Microbial Enumeration for Nutritional SupplementsAOAC 966.23 Microbial Limits in CosmeticsEN 556-1 Requirements for Medical Devices Labeled ‘Sterile’EN 556-2 Requirements for Sterile Barrier SystemsEN 868-1 Packaging Materials for Terminally Sterilized Medical DevicesEN 868-2 Sterilization WrapsEN 868-3 Paper for Use in SterilizationEN 868-4 Paper Bags for Steam SterilizationEN 868-5 Heat Sealable PouchesEN 868-6 Paper for Low Temperature SterilizationEN 868-7 Nonwoven WrapsEN 868-8 Reusable Textiles for Sterile Barrier SystemsEN ISO 11607-2 Packaging Validation RequirementsEP 2.6.1 Sterility Testing of Finished Dosage FormsEP 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration TestsEP 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified MicroorganismsFDA BAM Chapter 10 Listeria monocytogenes DetectionFDA BAM Chapter 14 Bacillus cereus TestingFDA BAM Chapter 18 Microbial Limits for CosmeticsFDA BAM Chapter 3 Aerobic Plate Count for Food and SupplementsFDA BAM Chapter 4 Enumeration of Yeast and MoldFDA BAM Chapter 5 Coliforms and E. coli DetectionFDA BAM Chapter 7 Staphylococcus aureus DetectionFDA BAM Chapter 8 Salmonella DetectionICH Q10 Pharmaceutical Quality SystemICH Q6A Specifications for New Drug SubstancesICH Q6B Specifications for Biotechnological ProductsICH Q7 GMP for Active Pharmaceutical IngredientsICH Q9 Quality Risk ManagementISO 11135 Validation of Sterilization by Ethylene OxideISO 11137-1 Sterilization of Healthcare Products – RadiationISO 11137-2 Establishing the Sterilization DoseISO 11137-3 Guidance on Dosimetric Aspects for Radiation SterilizationISO 11138-1 Biological Indicators – General RequirementsISO 11138-2 Biological Indicators for Ethylene Oxide Sterilization ProcessesISO 11138-3 Biological Indicators for Steam Sterilization ProcessesISO 11138-4 Biological Indicators for Dry Heat Sterilization ProcessesISO 11138-5 Biological Indicators for Low-Temperature Steam and FormaldehydeISO 11737-1 Bioburden Determination on Medical DevicesISO 11737-2 Tests of Sterility Assurance for Medical DevicesISO 13408-1 Aseptic Processing of Healthcare ProductsISO 13408-2 Sterilizing FiltrationISO 13408-3 Lyophilization for Aseptic ProcessingISO 13408-4 Clean-in-Place for Aseptic ProcessingISO 13408-5 Sterilization-in-PlaceISO 13408-6 Isolator Systems for Aseptic ProcessingISO 13408-7 Aseptic ConnectionsISO 14160 Sterilization of Medical Devices Using Liquid Chemical SterilantsISO 14644-1 Cleanroom Classification by Particle CountISO 14644-10 Classification of Surface Chemical CleanlinessISO 14644-2 Cleanroom Monitoring to Provide Evidence of CleanlinessISO 14644-3 Test Methods for CleanroomsISO 14644-4 Design, Construction and Start-Up of CleanroomsISO 14644-5 Operations in CleanroomsISO 14644-6 VocabularyISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-8 Airborne Molecular ContaminationISO 14644-9 Classification of Surface Particle CleanlinessISO 14698-1 Biocontamination Control in Cleanrooms and Controlled EnvironmentsISO 14698-2 Evaluation Methods for Biocontamination ControlISO 14937 General Requirements for Sterilization ProcessesISO 15883-1 Washer-Disinfectors for Medical DevicesISO 15883-2 Washer-Disinfectors for Surgical InstrumentsISO 15883-3 Washer-Disinfectors for Human Waste ContainersISO 15883-4 Washer-Disinfectors for Thermolabile EndoscopesISO 15883-5 Test Soils and Methods for Washer-DisinfectorsISO 15883-6 Washer-Disinfectors for Baby Bottles and UtensilsISO 17665-1 Moist Heat Sterilization of Healthcare ProductsISO 17665-2 Guidance on Moist Heat Sterilization ValidationISO 18362 Manufacture of Sterile Medicinal ProductsJP 4.05 Sterility Testing for Injectable ProductsJP 4.06 Microbial Limit Tests for Pharmaceutical ProductsPDA TR 1 Sterility Testing GuidelinePDA TR 27 Pharmaceutical Package IntegrityPDA TR 28 Process Simulation TestingPDA TR 36 Isolator Systems for Sterility AssurancePDA TR 69 Bioburden and Cleanroom Microbial ControlPDA TR 70 Sterilization of Drug Products by Moist HeatPh. Eur. 2.6.30 Bacterial Endotoxins – LAL TestPh. Eur. 5.1.10 Guidelines for Viral Safety of Biotechnological ProductsPh. Eur. 5.1.2 Biological Indicators for Sterilization ProcessesPh. Eur. 5.1.4 Cleanroom and Isolator Environmental MonitoringPh. Eur. 5.1.6 Container Closure Integrity for Sterile ProductsPh. Eur. 5.1.8 Microbiological Quality of Herbal PreparationsTGA TG-GMP Sterility Requirements for Medicinal ProductsUSP <1211> Sterilization and Sterility AssuranceUSP <1222> Terminally Sterilized Drug ProductsUSP <1229> Sterilization of Compendial ArticlesUSP <1231> Water for Pharmaceutical PurposesUSP <2021> Microbiological Testing of Nutritional and Dietary SupplementsUSP <2022> Microbiological Testing of Nonsterile Personal Care ProductsUSP <55> Biological Indicators – Resistance Performance TestsUSP <61.1> Microbial Limit Testing for CosmeticsUSP <61> Microbial Enumeration Test for Non-Sterile ProductsUSP <62> Test for Specified Microorganisms in Pharmaceutical ProductsUSP <71> Sterility Test for Parenteral Drug Products

Comprehensive Guide to EN ISO 11607-1 Packaging for Terminally Sterilized Medical Devices - Requirements Laboratory Testing Service Provided by Eurolab

EN ISO 11607-1 is a widely recognized international standard that outlines the requirements for packaging of terminally sterilized medical devices. The standard is developed and published by the International Organization for Standardization (ISO) in collaboration with the European Committee for Standardization (CEN). This comprehensive guide will provide detailed information about the relevant standards, legal and regulatory framework, and industry-specific requirements.

Relevant Standards

  • EN ISO 11607-1:2019 - Packaging for terminally sterilized medical devices - Part 1: Requirements

  • ASTM F2096-19 - Standard Guide for Packaging of Terminally Sterilized Medical Devices

  • TSE (Turkish Standards Institution) TS EN ISO 11607-1:2019 - Packaging for terminally sterilized medical devices - Part 1: Requirements

  • Other national and international standards may apply depending on the country or region

    • Legal and Regulatory Framework

    The legal and regulatory framework surrounding EN ISO 11607-1 is complex and involves multiple stakeholders, including governments, regulatory bodies, industry associations, and manufacturers. The standard is a requirement for medical device manufacturers to ensure the safety and efficacy of their products.

  • Medical Device Regulations (EU) 2017/745

  • Medical Device Directives (EU) 2007/47

  • FDA (US Food and Drug Administration) Guidance Documents

    • International and National Standards

    EN ISO 11607-1 is a harmonized standard that is recognized by the International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO). The standard is widely adopted across Europe, North America, and other regions.

  • IECQ (IEC Quality) Certification

  • ISO/IEC 17065:2012 - Conformity assessment - Requirements for assessing conformity to specifications

    • Standard Development Organizations

    The development of EN ISO 11607-1 involves collaboration between various stakeholders, including industry associations, regulatory bodies, and standards development organizations.

  • CEN (European Committee for Standardization)

  • ISO (International Organization for Standardization)

  • ASTM International (American Society for Testing and Materials)

    • Evolution of Standards

    Standards evolve over time to reflect changes in technology, regulations, and market demands. EN ISO 11607-1 is no exception, with revisions made periodically to ensure the standard remains relevant and effective.

  • Revision history of EN ISO 11607-1

  • Future developments and updates

    • Standard Numbers and Scope

    EN ISO 11607-1 covers the packaging requirements for terminally sterilized medical devices. The scope includes:

  • Packaging materials and construction

  • Sterilization processes and validation

  • Packaging performance testing and evaluation

    • Compliance Requirements

    Manufacturers must comply with EN ISO 11607-1 to ensure their products meet regulatory requirements.

  • Compliance with relevant regulations and standards

  • Implementation of quality management systems (QMS)

  • Audits and assessments for compliance

    • Standard-Related Information in Detail

    The following table provides a detailed overview of the standard-related information:

    Standard Title Scope

    --- --- ---

    EN ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements Packaging materials and construction, sterilization processes, packaging performance testing

    ASTM F2096-19 Standard Guide for Packaging of Terminally Sterilized Medical Devices Packaging requirements for terminally sterilized medical devices

    TSE TS EN ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements Packaging materials and construction, sterilization processes

    EN ISO 11607-1 is a critical standard that ensures the safety and efficacy of packaged medical devices.

    Why This Test is Needed

  • Ensuring packaging meets regulatory requirements

  • Preventing contamination and ensuring sterility

  • Maintaining product quality and performance

  • Reducing recalls and liability risks

    • Business and Technical Reasons for Conducting EN ISO 11607-1 Testing

  • Compliance with regulations and standards

  • Quality management system implementation

  • Audits and assessments for compliance

  • Risk assessment and mitigation through testing

    • Consequences of Not Performing This Test

  • Non-compliance with regulatory requirements

  • Product recalls and liability risks

  • Decreased customer confidence and trust

  • Negative impact on business reputation and financial performance

    • Industries and Sectors Requiring EN ISO 11607-1 Testing

  • Medical device manufacturers

  • Pharmaceutical companies

  • Healthcare providers

  • Regulatory bodies

    • Risk Factors and Mitigation Strategies

    EN ISO 11607-1 testing helps mitigate risks associated with packaging medical devices.

    Risk Factor Mitigation Strategy

    --- ---

    Contamination and sterility issues Implementing validated sterilization processes

    Packaging material defects Selecting materials that meet regulatory requirements

    Standard Requirements in Detail

    The following table provides a detailed overview of the standard requirements:

    Standard Requirement Description

    --- ---

    1.1 The packaging shall be designed and constructed to prevent contamination and ensure sterility

    1.2 The packaging material shall meet the requirements specified in ISO 11135:2014

    1.3 The sterilization process shall be validated according to ISO 11140-1:2014

    Standard Requirements and Needs in Detail

    The following table provides a detailed overview of the standard requirements:

    Standard Requirement Description

    --- ---

    EN ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements

    ASTM F2096-19 Standard Guide for Packaging of Terminally Sterilized Medical Devices

    TSE TS EN ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements

    Standard Requirements and Needs in Summary

    EN ISO 11607-1 is a critical standard that ensures the safety and efficacy of packaged medical devices. Manufacturers must comply with this standard to ensure their products meet regulatory requirements.

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