This document provides testing procedures and requirements on the evaluation processes for the sortability of plastic packaging with regard to compatibility of the design with state-of-the-art collecting and sorting processes for the plastic used.
This document covers any packaging predominantly made of plastic and separate packaging components predominantly made of plastic, both in case they undergo sorting processes.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day

This document covers the design of any flexible packaging with the main body of the packaging unit predominantly made of PE or PP and the design of separate components predominantly made of flexible PE or flexible PP, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes and useability of the recyclates.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Standard
    36 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid PET packaging that does not fall within the definition of a PET bottle as outlined in Part 4 of this document, with respect to compatibility of the design with the state-of-the-art collection, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of materials other than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process of any rigid PET packaging that does not fall within the definition of a PET bottle as outlined in Part 4 of this document, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes, and the characterization of the output(s) compared to a reference material.
Packaging constituents and packaging components made of other materials than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    23 pages
    English language
    e-Library read for
    1 day

This document covers the design of any bottle with the main body of the packaging unit predominantly made of PET and the design of separate components predominantly made of PET, with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    20 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid packaging with the main body of the packaging unit predominantly made of PE or PP and the design of separate components predominantly made of rigid PE or rigid PP, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Standard
    28 pages
    English language
    e-Library read for
    1 day

This document provides a framework and principles for design for recycling documents for assessing the identification of the level of compatibility of plastic-packaging feature with the applicable collection, sorting and recycling processes, describing the level of compatibility.
This document covers any packaging predominantly made of plastic and separate components predominantly made of plastic. It aims to provide a consistent approach for the guidelines and protocols for each polymer and format.

  • Standard
    39 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process for bottles predominantly made of PET with respect to compatibility of the design with recycling processes.
Packaging components and ancillary elements made of other materials than PET are also covered by this document as they need to be evaluated for compatibility with the recycling processes.

  • Draft
    24 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid PET packaging that does not fall within the definition of a PET bottle as outlined in Part 4 of this document, with respect to compatibility of the design with the state-of-the-art collection, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of materials other than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    27 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid packaging with the main body of the packaging unit predominantly made of PS or XPS and the design of separate components predominantly made of rigid PS or XPS with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PS and XPS are also covered by this document as they need to be evaluated on compatibility with PS or XPS polymer recycling.

  • Draft
    12 pages
    English language
    e-Library read for
    1 day

This document covers the design of any flexible packaging with the main body of the packaging unit predominantly made of PE or PP and the design of separate components predominantly made of flexible PE or flexible PP, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes and useability of the recyclates.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Standard
    36 pages
    English language
    e-Library read for
    1 day

This document covers the design of any bottle with the main body of the packaging unit predominantly made of PET and the design of separate components predominantly made of PET, with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    20 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process of any rigid packaging which has its main component, in weight, predominantly made of EPS, with respect to compatibility of the design with recycling processes.
Packaging constituents and packaging components made of other materials than EPS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.
Unless otherwise stated, in the interests of better readability, ‘EPS packaging’ always includes ‘EPS white goods packaging and fish boxes’.

  • Draft
    13 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process of any flexible packaging with the main body of the packaging unit predominantly made of PE or PP and for the evaluation process of separate components predominantly made of flexible PE or flexible PP, with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes, and the characterization of the output(s) compared to a reference material.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Draft
    29 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid packaging which has its main component, in weight, predominantly made of EPS, with respect to compatibility of the design with state-of-the-art collecting, sorting, and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than EPS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.
Unless otherwise stated, in the interests of better readability, ‘EPS packaging’ always includes ‘EPS white goods packaging and fish boxes’.

  • Draft
    10 pages
    English language
    e-Library read for
    1 day

This document provides a framework and principles for design for recycling documents for assessing the identification of the level of compatibility of plastic-packaging feature with the applicable collection, sorting and recycling processes, describing the level of compatibility.
This document covers any packaging predominantly made of plastic and separate components predominantly made of plastic. It aims to provide a consistent approach for the guidelines and protocols for each polymer and format.

  • Standard
    39 pages
    English language
    e-Library read for
    1 day

This document provides testing procedures and requirements on the evaluation processes for the sortability of plastic packaging with regard to compatibility of the design with state-of-the-art collecting and sorting processes for the plastic used.
This document covers any packaging predominantly made of plastic and separate packaging components predominantly made of plastic, both in case they undergo sorting processes.

  • Standard
    34 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process of any rigid PET packaging that does not fall within the definition of a PET bottle as outlined in Part 4 of this document, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes, and the characterization of the output(s) compared to a reference material.
Packaging constituents and packaging components made of other materials than PET are also covered by this document as they need to be evaluated on compatibility with PET polymer recycling.

  • Standard
    23 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid packaging with the main body of the packaging unit predominantly made of PE or PP and the design of separate components predominantly made of rigid PE or rigid PP, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Draft
    23 pages
    English language
    e-Library read for
    1 day

This document covers the design of any rigid packaging with the main body of the packaging unit predominantly made of PE or PP and the design of separate components predominantly made of rigid PE or rigid PP, with respect to compatibility of the design with state-of-the-art collection, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PE and PP are also covered by this document as they need to be evaluated on compatibility with PE or PP polymer recycling.

  • Standard
    28 pages
    English language
    e-Library read for
    1 day

This document provides requirements for the evaluation process of any rigid packaging with the main body of the packaging unit predominantly made of PS or XPS and the design of separate components predominantly made of rigid PS or XPS, with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes, and the characterization of the output(s) compared to a reference material.
Packaging constituents and packaging components made of other materials than PS and XPS are also covered by this document as they need to be evaluated on compatibility with PS or XPS polymer recycling.

  • Draft
    14 pages
    English language
    e-Library read for
    1 day

This document specifies test methods for the determination of the chemical compatibility of packaging/ IBC made from polyethylene (PE), fluorinated polyethylene and co-extruded plastics. It covers the determination of adequate plastics compatibility against the following processes of deterioration:
—     softening due to absorption (swelling);
—     stress cracking;
—     combinations thereof.
This document is applicable to:
—     drums and jerricans made from plastics;
—     composite packaging (plastics) with inner receptacle made from plastics;
—     rigid plastics IBCs (types 31H1 and 31H2);
—     composite IBCs with rigid plastics inner receptacles (type 31HZ1);
used for the transport of liquid dangerous goods.
Proof of adequate plastics compatibility obtained using the test procedures specified in this document is only applicable to the above packaging and IBC types of the following materials and material specifications:
—     packaging and IBCs made from PE;
—     packaging and IBCs made from PE, whose internal surfaces are fluorinated; and
—     packaging and IBCs which are coextrusion blow moulded and have walls with the following multilayer structure (from inside to outside):
—    polyamide (PA), bonding agents, PE, or
—    ethylene vinyl alcohol (EVOH), bonding agents, PE.
Note              Packaging and IBCs made from PE and packaging and IBCs made from PE with fluorinated internal surfaces, deteriorate additionally due to molecular degradation reactions with the corresponding packaged substances. For this, the chemical compatibility can also be verified by the type tests described in ISO 13274:2013, Annex B, B.2.3, using the standard liquid nitric acid (55 %) or appropriate original packaged substances. Packaging made from Coex PE/PA and Coex PE/EVOH is not resistant to polar acid molecularly degrading substances such as nitric acid, with the result that a corresponding method is not considered for this process of deterioration in this document.

  • Standard
    18 pages
    English language
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This document specifies the requirements and recommendations for establishing a traceability system for food in cold chain logistics, which enables integrated functions such as collecting traceability information, managing traceability information and implementing traceability. This document is applicable to the management processes by supporting food traceability whereas cold chain logistics service providers are needed, covering transportation, warehousing, loading and unloading and other related points in cold chain logistics links towards the end customers.

  • Technical specification
    12 pages
    English language
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This document specifies test methods for the determination of the chemical compatibility of packaging/ IBC made from polyethylene (PE), fluorinated polyethylene and co-extruded plastics. It covers the determination of adequate plastics compatibility against the following processes of deterioration:
—     softening due to absorption (swelling);
—     stress cracking;
—     combinations thereof.
This document is applicable to:
—     drums and jerricans made from plastics;
—     composite packaging (plastics) with inner receptacle made from plastics;
—     rigid plastics IBCs (types 31H1 and 31H2);
—     composite IBCs with rigid plastics inner receptacles (type 31HZ1);
used for the transport of liquid dangerous goods.
Proof of adequate plastics compatibility obtained using the test procedures specified in this document is only applicable to the above packaging and IBC types of the following materials and material specifications:
—     packaging and IBCs made from PE;
—     packaging and IBCs made from PE, whose internal surfaces are fluorinated; and
—     packaging and IBCs which are coextrusion blow moulded and have walls with the following multilayer structure (from inside to outside):
—    polyamide (PA), bonding agents, PE, or
—    ethylene vinyl alcohol (EVOH), bonding agents, PE.
Note              Packaging and IBCs made from PE and packaging and IBCs made from PE with fluorinated internal surfaces, deteriorate additionally due to molecular degradation reactions with the corresponding packaged substances. For this, the chemical compatibility can also be verified by the type tests described in ISO 13274:2013, Annex B, B.2.3, using the standard liquid nitric acid (55 %) or appropriate original packaged substances. Packaging made from Coex PE/PA and Coex PE/EVOH is not resistant to polar acid molecularly degrading substances such as nitric acid, with the result that a corresponding method is not considered for this process of deterioration in this document.

  • Standard
    18 pages
    English language
    e-Library read for
    1 day

This document specifies test methods for the determination of the chemical compatibility of packaging/ IBC made from polyethylene (PE), fluorinated polyethylene and co-extruded plastics. It covers the determination of adequate plastics compatibility against the following processes of deterioration: — softening due to absorption (swelling); — stress cracking; — combinations thereof. This document is applicable to: — drums and jerricans made from plastics; — composite packaging (plastics) with inner receptacle made from plastics; — rigid plastics IBCs (types 31H1 and 31H2); — composite IBCs with rigid plastics inner receptacles (type 31HZ1); used for the transport of liquid dangerous goods. Proof of adequate plastics compatibility obtained using the test procedures specified in this document is only applicable to the above packaging and IBC types of the following materials and material specifications: — packaging and IBCs made from PE; — packaging and IBCs made from PE, whose internal surfaces are fluorinated; and — packaging and IBCs which are coextrusion blow moulded and have walls with the following multilayer structure (from inside to outside): — polyamide (PA), bonding agents, PE, or — ethylene vinyl alcohol (EVOH), bonding agents, PE. Note Packaging and IBCs made from PE and packaging and IBCs made from PE with fluorinated internal surfaces, deteriorate additionally due to molecular degradation reactions with the corresponding packaged substances. For this, the chemical compatibility can also be verified by the type tests described in ISO 13274:2013, Annex B, B.2.3, using the standard liquid nitric acid (55 %) or appropriate original packaged substances. Packaging made from Coex PE/PA and Coex PE/EVOH is not resistant to polar acid molecularly degrading substances such as nitric acid, with the result that a corresponding method is not considered for this process of deterioration in this document.

  • Standard
    10 pages
    English language
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  • Standard
    11 pages
    French language
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This document gives information on environmentally conscious packaging design based on the standards on packaging and the environment. It provides essential tips on how to improve packaging through reduction processes and includes practical examples to illustrate these points. This document is applicable to all suppliers responsible for placing packaging or packaged goods on the market.

  • Technical report
    54 pages
    English language
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This document specifies the reference architecture for a hyperloop system. It specifies the functions of each (sub)system classifying them in different functional blocks, their different possible implementations, and highlights the interactions between them.
The interfaces of the transportation system based on interactions are listed, whether it be internal interfaces or exterior interfaces. The characterization considers the technical as well as operational features of the transport service.

  • Standard
    17 pages
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This document specifies requirements and guidelines for refrigerated storage services and refrigerated transport services for foods, in the business to business (B to B) logistics sector in order to ensure that cold chains are properly maintained. This document does not apply to logistics services for cosmetics, cigarettes, pharmaceutical and medical products, over-the-counter drugs and commercially available medicine. This document does not apply to customs operations. This document applies to environments where refrigeration must be created and maintained, and does not apply to environments needing to raise storage temperatures.

  • Standard
    12 pages
    English language
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  • Standard
    12 pages
    French language
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  • Standard
    12 pages
    French language
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  • Standard
    12 pages
    French language
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This document specifies the reference architecture for a hyperloop system. It specifies the functions of each (sub)system classifying them in different functional blocks, their different possible implementations, and highlights the interactions between them.
The interfaces of the transportation system based on interactions are listed, whether it be internal interfaces or exterior interfaces. The characterization considers the technical as well as operational features of the transport service.

  • Standard
    17 pages
    English language
    e-Library read for
    1 day

This document specifies requirements for refrigerated delivery service providers to deliver goods directly from the last contactless refrigerated goods operation areas at distribution centres to recipients through contactless cold chain, depending on customers' needs. This document does not apply to the transfer of goods between distribution centres. This document includes requirements for: — refrigerated delivery service providers; — facilities and the equipment involved in contactless refrigerated delivery; — the operation process; — the handling of abnormal conditions. This standard is also applicable to scenarios that need contactless cold chain delivery under special circumstances, such as epidemics.

  • Standard
    11 pages
    English language
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  • Standard
    12 pages
    French language
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This document specifies the definitions, functional requirements and evaluation criteria of active packaging.

  • Standard
    13 pages
    English language
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Hyperloop transport services are designed to support passenger transport and cargo transport. For each of the transport service user/customer requirements and expectations are different.
This document defines the hyperloop transport services supported by a hyperloop system and provides means for characterization and description of these services. The characterization considers the technical as well as operational / commercial features of each transport service.

  • Standard
    33 pages
    English language
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Hyperloop transport services are designed to support passenger transport and cargo transport. For each of the transport service user/customer requirements and expectations are different.
This document defines the hyperloop transport services supported by a hyperloop system and provides means for characterization and description of these services. The characterization considers the technical as well as operational / commercial features of each transport service.

  • Standard
    33 pages
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This document specifies a laboratory scale test method for determining the degree of disintegration of test items when exposed to well-managed home composting conditions by the weight evaluation method (WE method) using sieving and evaluation by weighing.
The test method is not applicable for the determination of the biodegradability of test items under home composting conditions. Additional testing is necessary for making claims concerning the suitability for home composting. This document is not appropriate for claims relating to the suitability for home composting.
This test method is carried out at laboratory scale under controlled conditions. Therefore, it does not reproduce any real home composting conditions, but it is devised to gain information on the potential of the test item to disintegrate sufficiently. A test item that passes this test is assumed to be capable of undergoing full disintegration in a 12 months home composting cycle carried out under well managed conditions. For features of well-managed home composting see EN 17427:2022, Annex E.

  • Standard
    13 pages
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SIGNIFICANCE AND USE
4.1 The purpose of this guide is to provide direction for uniform conditioning methodology when conducting special preparations of plastic packagings as prescribed for conducting United Nations (UN) drop test. This guide provides a uniform approach for conditioning of plastic packaging intended for liquid hazardous materials (dangerous goods).  
4.2 The hazardous materials (dangerous goods) regulations certification process requires that plastic packagings undergo special preparations before performing the UN drop test. The regulations do not include uniform procedures for conducting special preparations. Non-uniform procedures allow for differences in methods between test facilities which may result in different test results.  
4.3 49 CFR 178.603(c) state that special conditioning for drop testing is required for all plastic drums, plastic jerricans, plastic boxes (other than expanded polystyrene boxes), composite packagings (plastic material), and combination packagings with plastic inner packagings (other than plastic bags intended to contain solids or articles). It further states that drop testing shall be conducted when the temperature of the test sample (packagings and contents) has been reduced to –18 °C or lower. Test liquids shall be kept in the liquid state, if necessary, by the addition of antifreeze. Water/antifreeze solutions with a minimum 0.95 specific gravity for testing at –18 °C or lower are considered acceptable test liquids. These conditioning requirements also apply to IBCs and Large Packagings. Refer to 49 CFR §178.810(b)(4) and §178.965(c), respectively.  
4.4 A 24-hour conditioning period may not be sufficient time for the packaging and contents to reach the required temperature.  
4.5 This guide provides additional information not in the regulations that will facilitate consistent test sample conditioning among test facilities. The information and guidance provided here are intended to meet or exceed the minimum requirements of the regul...
SCOPE
1.1 This guide is intended to provide a standardized method and a set of basic instructions for special preparation conditioning of drop test samples being subjected to United Nations (UN) performance-oriented packaging certification as required by United States Department of Transportation Title 49 Code of Federal Regulations (49 CFR) and the United Nations Recommendations on the Transport of Dangerous Goods (UN).  
1.2 This guide provides guidance on conditioning test samples for drop testing plastic Non-Bulk Packaging, Intermediate Bulk Container (IBC), and Large Packaging designs intended for liquid hazardous materials (dangerous goods) as required by 49 CFR §178.603(c)(1), §178.810(b)(4), and §178.965(c), respectively. This guide also provides the minimum information that should be documented when conducting special preparation conditioning.  
1.3 The user of this guide shall be trained in accordance with 49 CFR §172.700 and other applicable hazardous materials regulations including: the International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air, the International Maritime Dangerous Goods Code (IMDG Code), and carrier rules such as the International Air Transport Association (IATA) Dangerous Goods Regulations.  
1.4 Units—The values stated in SI units are regarded as the standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, G...

  • Guide
    4 pages
    English language
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SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Guide
    27 pages
    English language
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  • Guide
    27 pages
    English language
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SIGNIFICANCE AND USE
4.1 This practice covers the requirements for the commercial preservation, packaging, packing (exterior container), unitization, and marking for supplies and equipment. It provides for multiple handling and shipment by any mode, and storage periods of a minimum of one year in enclosed facilities without degradation or damage to the product within the container. It also provides for package quantities suitable for redistribution without additional repackaging or marking. Planned storage that exceeds one year requires more than minimum requirements for physical and mechanical protection.  
4.2 This practice is applicable to Department of Defense shipments for:  
4.2.1 Items intended for immediate use;  
4.2.2 Items for not-mission-capable supply;  
4.2.3 Items intended for depot operational consumption;  
4.2.4 Small parcel shipments (CONUS), not-for-stock; and  
4.2.5 Direct vendor deliveries (CONUS ONLY).  
4.3 All other Department of Defense shipments shall be in accordance with MIL-STD-2073–1.
SCOPE
1.1 This practice establishes minimum requirements for packaging of supplies and equipment, exclusive of ammunition, explosives, or hazardous materials, as covered in Title 49 of the Code of Federal Regulations.  
1.2 The values stated in inch-pound units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    5 pages
    English language
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SIGNIFICANCE AND USE
4.1 This practice provides:  
4.1.1 A holistic approach to evaluate risks associated with an integrity breach in a SUS, considering its life cycle from development to disposal.  
4.1.2 An overview of physical and microbial test methods that could be applicable to SUS testing, for qualification and validation purposes, as well as for routine testing.  
4.1.3 Information on the main challenges faced when testing SUSs for integrity.  
4.2 This practice can be used by SUS suppliers and SUS end users to define an integrity assurance strategy for SUSs, with the relevant tests when appropriate.
SCOPE
1.1 This practice uses quality risk management (QRM) and life-cycle approach to establish integrity assurance of single-use systems (SUSs), such as but not limited to bag assemblies and liquid transfer sets for processing, storage, and shipping of (bio)pharmaceutical products. It gives recommendations to identify failure modes and risks associated with such systems and their use-cases and how to identify the relevant leak(s) of concern. Integrity assurance in this context is limited to the barrier properties of the SUS, linked to microbial integrity and bioburden control (product quality) and liquid product loss (operator and environmental contamination). The required level of integrity assurance will depend on how critical the application is and can be interpreted in different ways. It can also vary between processes and applications used for different modalities (for example, advanced therapies). Other package barrier properties different from that, such as but not limited to gas barrier properties for gas headspace preservation, as well as porous barrier packages are not considered. Specific aspects how to address the contamination control strategy (CCS) for SUS are also described in chapters 8.131ff of the new Revision of Annex 1 (1),2 including chapter 8.137 regarding SUS integrity.  
1.2 The test method overview provides descriptions that focus on the standard test setup and the identification of challenges in combination with SUSs. Details, including specific test setups, test parameter, and result interpretation, are not discussed. For more detailed information refer to Test Method E3251 for microbial test methods, and to Test Method E3336 for physical test methods.  
1.3 This practice is not intended to apply to the use of single-use technology for primary containers, combination products (products composed of any combination of a drug, device, or biological product), or devices. Appropriate procedures related to these products are discussed in documents covering the integrity assurance for primary containers (2) or medical products (1, 3).  
1.4 Techniques and procedures for complaint management and root cause analysis related to integrity failures are also not discussed.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
    13 pages
    English language
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  • Standard
    13 pages
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SIGNIFICANCE AND USE
4.1 Standards and practices for assuring safety, quality, and weight stabilization during key steps of the cannabis/hemp flowers sojourn are in order.  
4.2 This guide is intended to assist in assuring safety, quality, and weight stabilization of cannabis/hemp flower during indoor packaging operations.  
4.3 This guide is intended to assist in assuring that packaged cannabis/hemp flower has a water activity of 0.55 to 0.65 per Specification D8197.  
4.4 This guide is intended to be used by purveyors who move the cured crop to consumer or non-consumer packaging used for distribution.
SCOPE
1.1 Specification D8450 specifies the environmental conditions, such as temperature, humidity, and lighting under which the cured, dry, cannabis/hemp flowers in fresh format intended for human use are to be packaged to assure the safety, quality, and weight stabilization of the packaged flower. This guide suggests means by which the packager of cannabis/hemp can meet Specification D8450.  
1.1.1 This guide does not apply to frozen cannabis/hemp.  
1.1.2 This guide does not apply to cannabis/hemp intended for extraction.  
1.2 This guide applies only to controlling an indoor environment (heat, cooling, humidity control, lighting) surrounding packaging operations. Outdoor operations are outside the scope of this guide and are not addressed.  
1.3 This guide can be used by licensed operators in the cannabis/hemp space who move the cured crop(s) into consumer or non-consumer packaging used for distribution.  
1.4 Security of the cannabis/hemp flower during the packaging process is not within the scope of this guide.  
1.5 This guide is intended to remain valid until the packaged cannabis/hemp flower is placed in storage or transit.  
1.6 Authorities having jurisdiction may have additional or alternate requirements which shall take precedence or supersede this guide.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This document specifies performance requirements and methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products. This document is intended for type approval only (see 2.5) and is not intended for quality assurance purposes.
This document applies to non-reclosable packages of the single-use type consisting of one or more individual units.
Non-reclosable packages for pharmaceutical products are excluded from the scope of this document. These are the subject of a separate standard, ISO 14375, Child-resistant non-reclosable packaging for pharmaceutical products — Requirements and testing.

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This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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This document specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This document is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

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This document specifies performance requirements and methods of test for non-reclosable packaging that has been designated child-resistant and which is intended to contain non-pharmaceutical products. This document is intended for type approval only (see 2.5) and is not intended for quality assurance purposes.
This document applies to non-reclosable packages of the single-use type consisting of one or more individual units.
Non-reclosable packages for pharmaceutical products are excluded from the scope of this document. These are the subject of a separate standard, ISO 14375, Child-resistant non-reclosable packaging for pharmaceutical products — Requirements and testing.

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ABSTRACT
This guide identifies the key information required to ensure that selected packaging will pass the United Nations (UN) packaging certification at the level that is appropriate for its intended use. This guide covers test procedures for transportation of hazardous material packagings for net masses except those used for infectious substances, radioactive materials, cylinders, and other receptacles for gases and does not replace domestic or international requlatory requirements for hazardous material packagings. The UN performance tests are based on the degree of hazard posed by the proposed materials to be packaged which are also assigned to a specific packing group. Only packaging designs that meet the UN performance standards are to be marked with a UN mark. Tests include drop test, leakproofness test, stack test, vibration test, pressure differential test, hydrostatic pressure test, and cobb water absorption test.
SIGNIFICANCE AND USE
4.1 The UN performance tests are based on the degree of hazard presented by the proposed hazardous material(s) to be packaged.  
4.2 Substances and articles which are hazardous are assigned to a specific packing group as defined in 3.8.1 and may be determined by referencing 49 CFR 172.101 hazardous materials table.  
4.3 Only packaging designs that have been successfully tested to the UN performance standards as defined in 3.8.2 may have the UN specification mark applied to the outer packaging. Hazardous Materials may not be transported in a packaging that does not bear the appropriate UN specification markings unless otherwise authorized by the applicable competent authority.  
4.4 Packages successfully tested to the UN performance standards may or may not withstand the North American distribution environment. To further evaluate the suitability of the package it is strongly recommended that additional tests as detailed in Practice D4169 or other carrier specified test requirements be conducted.
SCOPE
1.1 This guide identifies the key information required for United Nations (UN) packaging certification to ensure the selected packaging will be certified to the appropriate level for its intended use and provides guidance for locating relevant sections of the United States Department of Transportation Title 49 Code of Federal Regulations (CFR). Consult with a regulatory specialist whenever needed.  
1.2 This guide provides assistance in determining the appropriate performance tests required to certify packaging designs to the United States Department of Transportation Title 49 Code of Federal Regulations performance oriented packaging standards based on the United Nations Recommendations on the Transport of Dangerous Goods..  
1.3 This guide covers the testing for transportation of hazardous materials (dangerous goods) packagings for net masses not exceeding 400 kg (880 lb) or capacities not exceeding 450 L (119 gal), excepting packagings for infectious substances, radioactive materials, cylinders and other receptacles for gases.  
1.4 This guide does not replace domestic or international regulatory requirements for hazardous materials packaging but is strongly recommended to be used in conjunction with those regulations.  
1.5 The user of this guide must be trained in accordance with the United States Department of Transportation Title 49 Code of Federal Regulations (49 CFR) as required by 172.700 and should be familiar with other applicable hazardous materials regulations such as: International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air, and the International Maritime Dangerous Goods Code (IMDG Code) and carrier rules such as International Air Transport Association (IATA) Dangerous Goods Regulations.  
1.6 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not...

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SCOPE
1.1 This terminology is a compilation of definitions of technical terms used in the packaging and distribution environments. Terms that are generally understood or adequately found in other readily available sources are not included.  
1.2 A definition is a single sentence with additional information included in discussions.  
1.3 Definitions that are identical to those published by another standards organization or ASTM committee are identified with the name of the organization or ASTM committee.  
1.4 The definitions in this terminology are grouped into related areas under principal concepts. The broad descriptor term for each group is followed in alphabetical order by narrower terms and related terms. Cross-references are included where the concept group is not obvious.  
1.5 Terminology related to flexible barrier packaging is found in Terminology F17.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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SIGNIFICANCE AND USE
5.1 Regulations prescribing the test procedures for hazardous materials packaging allow for the substitution of non-hazardous fill materials for packaging performance tests with certain limitations prescribed and guidance offered (see 49 CFR 178.602(c)). This regulatory guidance has proven to be flexible enough, in common industry practice, to produce variations in the selection of fill materials for package performance tests sufficient to cause inconsistent and non-repeatable test results. This variation creates significant problems in product liability, packaging selection and regulatory enforcement in this highly regulated industry. Use of this guide should enhance uniformity in test procedures.  
5.2 Consistent and repeatable test results coupled with clear test fill product descriptions will enhance transportation safety by simplifying packaging selection. This will also increase the general level of confidence that package testing, manufacture, and use are being guided by sound, generally accepted engineering principles. It also aids in clarifying expectations between the packaging industry and the regulatory authorities.  
5.3 The guide will be used by packaging manufacturers and packaging test labs to create packaging test plans that meet customer needs and conform to the HMR. In addition, for the user of a packaging, certain information about the type and physical characteristics of the material used to test the packaging must be available in the test report and/or notification instruction to allow evaluation of whether a particular packaging was tested with a substitute material appropriate for the hazardous material to be shipped.
SCOPE
1.1 The purpose of this guide is to clarify the selection, use, and description criteria of non-hazardous particulate solid substitutes used to replace hazardous materials for the purpose of performance testing packagings. This includes identification of the physical parameters of substitute non-hazardous solid test fill materials that may affect packaging performance and test results and should be considered when selecting and describing a test fill material that conforms to the requirements of the Hazardous Materials Regulations (HMR). This guide is intended for use with package testing procedures for particulate solid materials that have flow characteristics. It is not intended for use with hazardous articles.  
1.2 This guide provides information to assist packaging users, manufacturers, and performance testing service suppliers regarding the types of physical properties that should be considered when selecting substitute filling substances for the testing, certification and manufacture of packagings under the United Nations packaging protocols (UN Recommendations on the Transport of Dangerous Goods-Model Regulations) as adopted by US DOT in 49 CFR HMR.  
1.3 This guide provides the suggested minimum information concerning the physical characteristics of the filling substances that should be documented in the certification test report and notification to users to allow for test repeatability and analysis, and to provide guidance to the user of a packaging of pertinent physical differences between potential hazardous lading and the filling substance with which the packaging was tested.  
1.4 This guide does not purport to address regulatory requirements regarding the compatibility of filling substances with transport packagings. Compatibility requirements must be assessed separately, but it should be noted that under certain national and international dangerous goods regulations, the selection of the filling substances for package performance testing may be prescribed with respect to chemical compatibility requirements.
Note 1: Under the US HMR determination of packaging compatibility with a particular hazardous fill material is “the responsibility of the person offering the hazardous material for transportation” as prescribed in 49 CFR §...

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This document describes the general specifications of temperature-sensitive medicinal packaging based on the principles of good distribution practice (GDP). It also specifies test methods to validate the package performance for temperature-sensitive medicinal products. This covers the procedures of temperature-recording and testing methods on the performance of insulated containers such as dimensions, weights, storage capacity and robustness in temperature-controlling. This document does not guarantee the quality and safety of all medicinal products. Under special circumstances where the weight or the characteristics of the products and environment show specific conditions, agreements are followed. This document does not cover the active packaging system, but only covers the passive packaging system able to control the desired temperature without any power sources.

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This document lists the relevant standards from various fields and provides a standardization roadmap for hyperloop systems. The roadmap will provide guidance on the applicable standards from various fields, those that need amending and the new-to be developed standards.

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This document lists the relevant standards from various fields and provides a standardization roadmap for hyperloop systems. The roadmap will provide guidance on the applicable standards from various fields, those that need amending and the new-to be developed standards.

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