This document specifies the safety requirements of hydrogen gas generation appliances or systems that use electrochemical reactions to electrolyse water to produce hydrogen, herein referred to as hydrogen generators.

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This document specifies the safety requirements of hydrogen gas generation appliances or systems that use electrochemical reactions to electrolyse water to produce hydrogen, herein referred to as hydrogen generators.

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This document specifies the safety requirements of hydrogen gas generation appliances or systems that use electrochemical reactions to electrolyse water to produce hydrogen, herein referred to as hydrogen generators.

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This document specifies the minimum requirements for rubber hoses used for transferring ammonia, in liquid or in gaseous form, at ambient temperatures from −40 °C up to and including +55 °C at a working pressure of 2,5 MPa (25 bar). It does not include specifications for end fittings and is limited to the performance of the hoses and hose assemblies.

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This document specifies the minimum requirements for rubber hoses used for transferring ammonia, in liquid or in gaseous form, at ambient temperatures from −40 °C up to and including +55 °C at a working pressure of 2,5 MPa (25 bar). It does not include specifications for end fittings and is limited to the performance of the hoses and hose assemblies.

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This document specifies the minimum requirements for rubber hoses used for transferring ammonia, in liquid or in gaseous form, at ambient temperatures from −40 °C up to and including +55 °C at a working pressure of 2,5 MPa (25 bar). It does not include specifications for end fittings and is limited to the performance of the hoses and hose assemblies.

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SIGNIFICANCE AND USE
5.1 In the design and operation of reverse osmosis installations, it is important to predict the calcium carbonate scaling properties of the concentrate stream. Because of the increase in total dissolved solids in the concentrate stream and the differences in salt passages for calcium ion, bicarbonate ion, and free CO2, the calcium carbonate scaling properties of the concentrate stream will generally be quite different from those of the feed solution. This practice permits the calculation of the S & DSI for the concentrate stream from the feed water analyses and the reverse osmosis operating parameters.  
5.2 A positive S & DSI indicates the tendency to form a calcium carbonate scale, which can be damaging to reverse osmosis performance. This practice gives procedures for the adjustment of the S & DSI.
SCOPE
1.1 This practice covers the calculation and adjustment of the Stiff and Davis Stability Index (S & DSI) for the concentrate stream of a reverse osmosis device. This index is used to determine the need for calcium carbonate scale control in the operation and design of reverse osmosis installations. This practice is applicable for concentrate streams containing more than 10 000 mg/L of total dissolved solids. For concentrate streams containing less than 10 000 mg/L of total dissolved solids, refer to Practice D3739.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered 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.

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SIGNIFICANCE AND USE
5.1 These practices may be used to determine whether a RO or NF device is free of leaks if the mechanical integrity of the device is to be confirmed. They may also be used to detect leaks in RO or NF devices whose operating performance indicates a possible leak. These practices may be used for either new or used devices.
SCOPE
1.1 These practices cover detecting leaks in which there is a direct communication between the feed or concentrate, or both, and the permeate. Several types of leaks are possible with the various configurations of reverse-osmosis (RO) and nanofiltration (NF) devices.  
1.2 Types of Leaks:  
1.2.1 With hollow-fiber devices, feed or concentrate leakage, or both, into the permeate stream by leaks through the tube sheet and past the tube sheet O-ring are possible. “Leaks” caused by broken fibers are not covered by these practices.  
1.2.2 With spiral-wound devices, leaks may occur through damage of the membrane surface itself by punctures or scratches, by glue-line failure, and by O-ring leaks on product tube interconnectors.  
1.2.3 With tubular devices, leaks due to membrane damage, tube end seal leaks, and leaks from broken tubes or product headers are possible.  
1.3 Three leak test practices are given as follows:    
Sections  
Practice A—Tube Sheet and O-Ring Leak Test for Hollow
Fiber Devices  
8 to 9  
Practice B—Vacuum Test for Spiral Wound Devices  
10 to 12  
Practice C—Dye Test for Spiral Wound and Tubular Devices  
13 to 18  
1.4 The values stated in SI units are to be regarded as 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, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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SIGNIFICANCE AND USE
5.1 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.  
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.  
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.  
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).  
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537, or for validation of PAT methods, which is covered in Guide E2898.  
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation, as well as EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for Finished Products.  
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.

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SIGNIFICANCE AND USE
5.1 During the operation of an RO system, system conditions such as pressure, temperature, conversion, and feed concentration can vary, causing permeate flow and salt passage to change. To effectively evaluate system performance, it is necessary to compare permeate flow and salt passage data at the same conditions. Since data may not always be obtained at the same conditions, it is necessary to convert the RO data obtained at actual conditions to a set of selected constant conditions, thereby standardizing the data. This practice gives the procedure to standardize RO data.  
5.2 This practice can be used for both spiral wound and hollow fiber systems.  
5.3 This practice can be used for a single element or a multi-element system. However, if the RO system is brine staged, that is, the brine from one group of RO devices is the feed to a second group of RO devices, standardize the permeate flow and salt passage for each stage separately.  
5.4 This practice is applicable for RO systems with high rejections and with no significant leaks between the feed-brine and permeate streams.
SCOPE
1.1 This practice covers the standardization of permeate flow, salt passage, and coefficient of performance data for reverse osmosis (RO) systems.  
1.2 This practice is applicable to waters including brackish waters and seawaters but is not necessarily applicable to waste waters.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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 requirements and gives recommendations for the mechanical design, material selection, fabrication, inspection, testing and preparation for shipment of shell-and-tube heat exchangers for the petroleum, petrochemical and natural gas industries.
This document supplements API Std 660, 9th edition (2015), the requirements of which are applicable with the exceptions specified in this document.
This document is applicable to the following types of shell-and-tube heat exchangers: heaters, condensers, coolers and reboilers.
This document is not applicable to vacuum-operated steam surface condensers and feed-water heaters.

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SIGNIFICANCE AND USE
4.1 This guide is intended to provide a series of evaluations that will assist engineers dealing with chemical environments in selecting appropriate alloys (1-3). In chemical environments, an important issue for determining general corrosion resistance is the temperature at which an alloy transitions from corrosion at a low rate to corrosion at a much higher rate. Other important concerns include the tendency towards crevice corrosion and stress corrosion cracking resistance, especially in hot chloride-containing aqueous environments.  
4.2 This guide is also intended for alloy developers to assist them in choosing environments and test methods that are of particular interest to the chemical process industries.  
4.3 The use of this approach will allow direct comparisons to be made among alloys from various suppliers and, thereby, to assist engineers in selecting the most appropriate materials for further testing to determine suitability in their application.
SCOPE
1.1 This guide covers an evaluation approach that is designed to provide information on the corrosion properties of wrought iron- and nickel-based alloys for the chemical process industries. This guide incorporates test conditions for general corrosion measurements in a variety of environments, crevice corrosion resistance in chloride environments, and stress corrosion cracking resistance in chloride environments.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.  
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 to 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.

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SIGNIFICANCE AND USE
4.1 Application of this guidance should enable PAT method developers to design and implement reliable PAT applications that avoid many common sources of error around sampling. Sampling is a key element of method and process validation plans.  
4.1.1 Many ASTM standards discuss sampling; however, almost all are very specific to a certain field or application. For example, the “Standard Practice for Automatic Sampling of Petroleum and Petroleum Products” (D4177) specifically covers information for the design, installation, testing, and operation of automated equipment for the extraction of representative samples of petroleum and petroleum products from a flowing stream and storing them in a sample receiver.  
4.1.2 Other useful ASTM standards include: E105 (Practice for Probability Sampling of Materials), E122 (Standard Practice for Calculating Sample Size to Estimate, With a Specified Precision, the Average for a Characteristic of a Lot or Process), E1402 (Standard Guide for Sampling Design), and E456 (Terminology Relating to Quality and Statistics). These standards review similar considerations as those addressed in this guidance and can be consulted for additional insight on how to deal with specific sample types or situations. However, such standards should be carefully reviewed for relevance to pharmaceutical applications.
SCOPE
1.1 This document is to be used as a guide to Process Analytical Technology (PAT) instrument sampling, and covers both the sample from which PAT data is collected and the sample that is taken for reference assay. The ASTM definition of a guide is a compendium of information or series of options that does not recommend a specific course of action. The intention of a guide is to increases the awareness of information and approaches in a given subject area, as such this guide should serve as a collation of points to consider when determining a sample practice for PAT instruments. It is not intended to serve as a practice to be followed. As a first step, one should define the overall goal of the PAT measurement. Once defined, this guide describes various considerations as they relate to the specific requirements that must be met to achieve the overall PAT goal, including the attributes to be measured, impact of the scale of the process, and interfacing of the measurement system to manufacturing equipment (including sampling system reliability). Additionally, it discusses the estimation and validation of the effective sample size and the overall contribution to the measurement. Related aspects of data collection and data processing as well as the use of risk assessments to optimize sampling and to understand the impact of potential sampling errors are also covered. Furthermore, considerations for process control and aspects pertaining to sample withdrawal and retention are also included. Lastly, continuous manufacturing processes require special considerations due to the time dependency associated with continuous operations as compared to batch manufacturing and special considerations are needed for sampling of such processes.  
1.2 This guide is limited to a high level overview of sampling considerations for PAT applied to any type of pharmaceutical manufacturing (for example, active pharmaceutical ingredient (API), solid oral dosage form, etc.). It is not intended to provide technology- or application-specific sampling guidance, or both. Instead, the intent is to evoke a thought process around sampling when developing a PAT application. While the focus is mainly on sampling considerations for on/in-line applications in solids, liquids, and gases (that is, in situ PAT measurements), many of the considerations also apply to at-line and off-line applications in which a sample is withdrawn from the process and subsequently presented for analysis.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardizatio...

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SIGNIFICANCE AND USE
5.1 In the design and operation of reverse osmosis and nanofiltration installations, it is important to predict the CaSO4, SrSO4, and BaSO4 scaling properties of the concentrate stream. Because of the increase in total dissolved solids and the increase in concentration of the scaling salts, the scaling properties of the concentrate stream will be quite different from those of the feed solution. This practice permits the calculation of the scaling potential for the concentrate stream from the feed water analyses and the reverse osmosis or nanofiltration operating parameters.  
5.2 Scaling by CaSO4, SrSO4, and BaSO4 will adversely affect the reverse osmosis or nanofiltration performance. This practice gives various procedures for the prevention of scaling.
SCOPE
1.1 This practice covers the calculation and adjustment of calcium, strontium, and barium sulfates for the concentrate stream of a reverse osmosis or nanofiltration system. The calculations are used to determine the need for scale control in the operation and design of reverse osmosis and nanofiltration installations. This practice is applicable for all types of reverse osmosis devices (tubular, spiral wound, and hollow fiber) and nanofiltration devices.  
1.2 This practice is applicable to both brackish waters and seawaters.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

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IEC 62703:2013 specifies the general aspects in the terminology and definitions related to the performance of fluorometric oxygen analyzers used for the continuous determination of dissolved oxygen partial pressure or concentration in liquid media; unifies methods used in making and verifying statements on the functional performance of such analyzers; specifies which tests should be performed in order to determine the functional performance and how such tests should be carried out and provides basic documents to support the application of standards of quality assurance within ISO 9001.

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ISO 10439-2:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-2:2015 specifies requirements for non-integrally geared centrifugal and axial compressors, in addition to the general requirements specified in ISO 10439-1. These machines do not have gears integral with their casing but can have external gears.

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ISO 10439-3:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft and integrally geared process centrifugal compressors, and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-4:2015 specifies integrally geared centrifugal compressors in conjunction with ISO 10439‑1.

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ISO 10439 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors, and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-1:2015 specifies general requirements applicable to all such machines.
ISO 10439-1:2015 does not apply to fans (these are covered by API 673) or blowers that develop less than 34 kPa (5 psi) pressure rise above atmospheric pressure. It also does not apply to packaged, integrally geared centrifugal plant, and instrument air compressors, which are covered by API 672. Hot gas expanders over 300 °C (570 °F) are not covered by ISO 10439-1:2015.
ISO 10439-1:2015 contains information pertinent to all equipment covered by the other parts of ISO 10439. It shall be used in conjunction with the following parts of ISO 10439, as applicable to the specific equipment covered:
ISO 10439‑2;
ISO 10439‑3
ISO 10439‑4

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ISO 10439-4:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439‑4:2015 specifies requirements for expander-compressors, in addition to the general requirements specified in ISO 10439‑1:2015.

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ISO 10439 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors, and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-1:2015 specifies general requirements applicable to all such machines. ISO 10439-1:2015 does not apply to fans (these are covered by API 673) or blowers that develop less than 34 kPa (5 psi) pressure rise above atmospheric pressure. It also does not apply to packaged, integrally geared centrifugal plant, and instrument air compressors, which are covered by API 672. Hot gas expanders over 300 °C (570 °F) are not covered by ISO 10439-1:2015. ISO 10439-1:2015 contains information pertinent to all equipment covered by the other parts of ISO 10439. It shall be used in conjunction with the following parts of ISO 10439, as applicable to the specific equipment covered: ISO 10439‑2; ISO 10439‑3 ISO 10439‑4

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ISO 10439-4:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439‑4:2015 specifies requirements for expander-compressors, in addition to the general requirements specified in ISO 10439‑1:2015.

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ISO 10439-2:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft, and integrally geared process centrifugal compressors and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-2:2015 specifies requirements for non-integrally geared centrifugal and axial compressors, in addition to the general requirements specified in ISO 10439-1. These machines do not have gears integral with their casing but can have external gears.

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ISO 10439-3:2015 specifies minimum requirements and gives recommendations for axial compressors, single-shaft and integrally geared process centrifugal compressors, and expander-compressors for special purpose applications that handle gas or process air in the petroleum, petrochemical, and natural gas industries. ISO 10439-4:2015 specifies integrally geared centrifugal compressors in conjunction with ISO 10439‑1.

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1.1   This European Standard applies to centrifuges for the separation or change in concentration of mixtures of liquids and solids.
It gives requirements to minimize the risks caused by the significant hazards arising during the operation of centrifuges as specified in 1.2.
1.2   This European Standard gives requirements for minimizing the risks caused by the following hazards:
-   mechanical hazards common to all types of centrifuges, except those specified in 1.3;
-   ergonomical hazards;
-   thermal hazards;
-   electrical hazards;
-   noise.
1.3   Types of centrifuges and hazards excluded
1.3.1   Types of centrifuges excluded:
-   centrifuges with a kinetic energy of rotation less than 200 J;
-   centrifuges for household use;
-   centrifuges for laboratory use according to EN 61010 2 020;
-   centrifuges for forming, i.e. centrifugal hot metal casting machines.
1.3.2   Hazards excluded
This European Standard does not deal explicitly with the hazards listed below.
NOTE 1   In cases, where such hazards might occur and could become relevant for the construction of the centrifuge, use specific standards for this hazard or make a risk analysis.
-   hazards caused by overpressure or negative pressure inside the centrifuge housing;
-   hazards specific to processing radioactive products;
-   hazards specific to microbiological processing - including viral and parasitic hazards;
-   hazards from processing corrosive and/or erosive materials;
-   hazards from processes involving flammable or explosive substances;
-   hazards caused by leakage of hazardous substances;
-   hazards caused by unsuitable hygienic design for applications involving food products;
-   inherent chemical hazards of process materials and/or service media and their biological effects on exposed persons;
NOTE 2   Inherently hazardous substances include toxic, carcinogenic and flammable substances for example. Other substances may be hazardous because of their condition in the centrifuge, i.e. temperature, velocity and vapour pressure.
-   hazards due to construction materials;
Materials used in the construction of centrifuges should not be hazardous in the condition in which they are used.
-   centrifuges subject to application specific standards (e.g. EN 12505).
NOTE 3   The design of centrifuges covered by EN 12547 varies to the extent that additional hazards may exist that are not covered by the requirements of this standard and is not excluded above. The manufacturer is responsible for providing suitable measures to deal with these hazards as part of a general risk assessment for the machine. Such measures are outside the scope of this standard and the direct responsibility of the manufacturer.
1.3.3   This European Standard gives guidance on the selection of performance levels according to EN ISO 13849 1:2008, but does not identify performance levels for specific applications.
1.4   This European Standard is not applicable to centrifuges which are manufactured before the date of its publication as EN.

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IEC 62703:2013 specifies the general aspects in the terminology and definitions related to the performance of fluorometric oxygen analyzers used for the continuous determination of dissolved oxygen partial pressure or concentration in liquid media; unifies methods used in making and verifying statements on the functional performance of such analyzers; specifies which tests should be performed in order to determine the functional performance and how such tests should be carried out and provides basic documents to support the application of standards of quality assurance within ISO 9001.

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ISO 12212:2012 specifies requirements and gives recommendations for the mechanical design, materials selection, fabrication, inspection, testing and preparation for shipment of hairpin heat exchangers for use in the petroleum, petrochemical and natural gas industries.
Hairpin heat exchangers include double-pipe and multi-tube type heat exchangers.

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ISO 12211:2012 specifies requirements and gives recommendations for the mechanical design, materials selection, fabrication, inspection, testing and preparation for shipment of spiral plate heat exchangers for the petroleum, petrochemical and natural gas industries.
ISO 12211:2012 is applicable to stand‑alone spiral plate heat exchangers and those integral with a pressure vessel.

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ISO 12211:2012 specifies requirements and gives recommendations for the mechanical design, materials selection, fabrication, inspection, testing and preparation for shipment of spiral plate heat exchangers for the petroleum, petrochemical and natural gas industries.
ISO 12211:2012 is applicable to stand‑alone spiral plate heat exchangers and those integral with a pressure vessel.

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ISO 12212:2012 specifies requirements and gives recommendations for the mechanical design, materials selection, fabrication, inspection, testing and preparation for shipment of hairpin heat exchangers for use in the petroleum, petrochemical and natural gas industries.
Hairpin heat exchangers include double-pipe and multi-tube type heat exchangers.

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ISO 13706:2011 gives requirements and recommendations for the design, materials, fabrication, inspection, testing and preparation for shipment of air-cooled heat exchangers for use in the petroleum, petrochemical and natural gas industries.
ISO 13706:2011 is applicable to air-cooled heat exchangers with horizontal bundles, but the basic concepts can also be applied to other configurations.

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ISO 13706:2011 gives requirements and recommendations for the design, materials, fabrication, inspection, testing and preparation for shipment of air-cooled heat exchangers for use in the petroleum, petrochemical and natural gas industries.
ISO 13706:2011 is applicable to air-cooled heat exchangers with horizontal bundles, but the basic concepts can also be applied to other configurations.

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ISO 13709:2009 specifies requirements for centrifugal pumps, including pumps running in reverse as hydraulic power recovery turbines, for use in petroleum, petrochemical and gas industry process services.
ISO 13709:2009 is applicable to overhung pumps, between-bearings pumps and vertically-suspended pumps

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ISO 13709:2009 specifies requirements for centrifugal pumps, including pumps running in reverse as hydraulic power recovery turbines, for use in petroleum, petrochemical and gas industry process services. ISO 13709:2009 is applicable to overhung pumps, between-bearings pumps and vertically-suspended pumps

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ISO 15547-2:2005 gives requirements and recommendations for the mechanical design, materials selection, fabrication, inspection, testing, and preparation for shipment of brazed aluminium plate-fin heat exchangers for use in petroleum, petrochemical and natural gas industries.

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ISO 15547-1:2005 gives requirements and recommendations for the mechanical design, materials selection, fabrication, inspection, testing, and preparation for shipment of plate-and-frame heat exchangers for use in petroleum, petrochemical and natural gas industries. It is applicable to gasketed, semi-welded and welded plate-and-frame heat exchangers.

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This document specifies a European designation system of wrought aluminium and aluminium alloys, based on an international designation system, and the procedure to obtain such international designation.
It is in accordance with the "Recommendation" dated December 15, 1970, as revised in March 2002, for an International Designation System for Wrought Aluminum and Wrought Aluminum Alloys issued by the Aluminum Association, Washington DC 20006, USA.
This standard applies to wrought products and to ingots intended to be wrought.

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This European Standard specifies material, design, inspection, testing and marking requirements of pressure equipment (e.g. vessels, pipes, valves) made from borosilicate glass 3.3 with a coefficient of mean linear thermal expansion of (3,3 +/- 0,1) x 10-6 K-1. The following are excluded: - circular, flat and tubular sight glasses, - equipment made from borosilicate glass with another coefficient of thermal expansion.

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This standard specifies the essential requirements for compatibility and interchangeability of borosilicate glass plant, piping and fittings from DN 15 to DN 1000.

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This European Standard specifies material, design, inspection, testing and marking requirements of pressure equipment (e.g. vessels, pipes, valves) made from borosilicate glass 3.3 with a coefficient of mean linear thermal expansion of (3,3 +/- 0,1) x 10-6 K-1. The following are excluded: - circular, flat and tubular sight glasses, - equipment made from borosilicate glass with another coefficient of thermal expansion.

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SIGNIFICANCE AND USE
4.1 Proper operation and maintenance of RO and NF systems are key factors in obtaining successful performance. This guide provides the necessary input for the evaluation of the performance of the RO and NF systems, the pretreatment system, and the mechanical equipment in the plant.  
4.2 This guide is for general guidance only and must not be used in place of the operating manual for a particular plant.  
4.3 Site-dependent factors prevent specific recommendations for all recordkeeping. Thus, only the more general recordkeeping is covered by this guide.  
4.4 This guide can be used for both brackish and seawater systems which contain either spiral-wound or hollow-fiber devices.
SCOPE
1.1 This guide covers procedures for well-defined recordkeeping of reverse osmosis (RO) and nanofiltration (NF) systems.  
1.2 This guide includes a start-up report, recordkeeping of RO and NF operating data, recordkeeping of pretreatment operating data, and a maintenance log.  
1.3 This guide is applicable to waters including brackish waters and seawaters but is not necessarily applicable to wastewaters.  
1.4 The values stated in SI units are to be regarded as 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 and health practices and determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
5.1 During the operation of an RO system, system conditions such as pressure, temperature, conversion, and feed concentration can vary, causing permeate flow and salt passage to change. To effectively evaluate system performance, it is necessary to compare permeate flow and salt passage data at the same conditions. Since data may not always be obtained at the same conditions, it is necessary to convert the RO data obtained at actual conditions to a set of selected constant conditions, thereby standardizing the data. This practice gives the procedure to standardize RO data.  
5.2 This practice can be used for both spiral wound and hollow fiber systems.  
5.3 This practice can be used for a single element or a multi-element system. However, if the RO system is brine staged, that is, the brine from one group of RO devices is the feed to a second group of RO devices, standardize the permeate flow and salt passage for each stage separately.  
5.4 This practice is applicable for RO systems with high rejections and with no significant leaks between the feed-brine and permeate streams.
SCOPE
1.1 This practice covers the standardization of permeate flow and salt passage data for reverse osmosis (RO) systems.  
1.2 This practice is applicable to waters including brackish waters and seawaters but is not necessarily applicable to waste waters.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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 This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.  
5.2 This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.  
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.  
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both. The intention of this standard is to describe and support the implementation of a PAT enabled Control Strategy, as described in ICH Q8(R2).  
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537, or for validation of PAT methods, which is covered in Guide E2898.  
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for Industry—PAT and FDA Guidance for Industry—Process Validation, as well as EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and EU Guideline on Process Validation for Finished Products.  
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.

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SIGNIFICANCE AND USE
During the operation of an RO system, system conditions such as pressure, temperature, conversion, and feed concentration can vary, causing permeate flow and salt passage to change. To effectively evaluate system performance, it is necessary to compare permeate flow and salt passage data at the same conditions. Since data may not always be obtained at the same conditions, it is necessary to convert the RO data obtained at actual conditions to a set of selected constant conditions, thereby standardizing the data. This practice gives the procedure to standardize RO data.
This practice can be used for both spiral wound and hollow fiber systems.
This practice can be used for a single element or a multi-element system. However, if the RO system is brine staged, that is, the brine from one group of RO devices is the feed to a second group of RO devices, standardize the permeate flow and salt passage for each stage separately.
This practice is applicable for reverse osmosis systems with high rejections and with no significant leaks between the feed-brine and permeate streams.
SCOPE
1.1 This practice covers the standardization of permeate flow and salt passage data for reverse osmosis (RO) systems.
1.2 This practice is applicable to waters including brackish waters and seawaters but is not necessarily applicable to waste waters.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This practice covers the standardization of permeate flow and salt passage data for reverse osmosis (RO) systems.
Formerly under the jurisdiction of Committee D19 on Water, this practice was withdrawn in January 2019 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.

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SIGNIFICANCE AND USE
5.1 These practices may be used to determine whether a RO or NF device is free of leaks if the mechanical integrity of the device is to be confirmed. They may also be used to detect leaks in RO or NF devices whose operating performance indicates a possible leak. These practices may be used for either new or used devices.
SCOPE
1.1 These practices cover detecting leaks in which there is a direct communication between the feed or concentrate, or both, and the permeate. Several types of leaks are possible with the various configurations of reverse-osmosis (RO) and nanofiltration (NF) devices.  
1.2 Types of Leaks:  
1.2.1 With hollow-fiber devices, feed or concentrate leakage, or both, into the permeate stream by leaks through the tube sheet and past the tube sheet O-ring are possible. “Leaks” caused by broken fibers are not covered by these practices.  
1.2.2 With spiral-wound devices, leaks may occur through damage of the membrane surface itself by punctures or scratches, by glue-line failure, and by O-ring leaks on product tube interconnectors.  
1.2.3 With tubular devices, leaks due to membrane damage, tube end seal leaks, and leaks from broken tubes or product headers are possible.  
1.3 Three leak test practices are given as follows:    
Sections  
Practice A—Tube Sheet and O-Ring Leak Test for Hollow
Fiber Devices  
8 to 9  
Practice B—Vacuum Test for Spiral Wound Devices  
10 to 12  
Practice C—Dye Test for Spiral Wound and Tubular Devices  
13 to 18
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
4.1 This guide is intended to provide a series of evaluations that will assist engineers dealing with chemical environments in selecting appropriate alloys (1-3). In chemical environments, an important issue for determining general corrosion resistance is the temperature at which an alloy transitions from corrosion at a low rate to corrosion at a much higher rate. Other important concerns include the tendency towards crevice corrosion and stress corrosion cracking resistance, especially in hot chloride-containing aqueous environments.  
4.2 This guide is also intended for alloy developers to assist them in choosing environments and test methods that are of particular interest to the chemical process industries.  
4.3 The use of this approach will allow direct comparisons to be made among alloys from various suppliers and, thereby, to assist engineers in selecting the most appropriate materials for further testing to determine suitability in their application.
SCOPE
1.1 This guide covers an evaluation approach that is designed to provide information on the corrosion properties of wrought iron- and nickel-based alloys for the chemical process industries. This guide incorporates test conditions for general corrosion measurements in a variety of environments, crevice corrosion resistance in chloride environments, and stress corrosion cracking resistance in chloride environments.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.  
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 and health practices and to determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
This guide supports the principles of Guide E2500 and extends these principles to the verification of PAT-enabled control systems.
This guide clarifies what is important for verification of PAT-enabled control systems. Such systems are often complex and require multidisciplinary and cross-functional teams to achieve optimum results. This guide provides a common basis for understanding requirements for all involved disciplines such as control engineering, development, manufacturing, and process validation.
SCOPE
1.1 This guide describes the verification of process analytical technology (PAT) enabled control systems using a science- and risk-based approach. It establishes principles for determining the scope and extent of verification activities necessary to ensure that the PAT-enabled control system is fit for purpose, properly implemented, and functions as expected.
1.2 In this guide, a PAT-enabled control system is considered to be the system that adjusts the manufacturing process using timely measurements (that is, during processing) of attributes of raw and in-process materials to determine responses that assure the process remains within specified boundaries and minimizes variability in the output material. The overall aim of the PAT-enabled control system is to ensure product quality. The PAT-enabled control system of a manufacturing process provides the capability to determine the current status of the process and drive the process to ensure the output material has the desired quality characteristics. The control system should be able to respond to process variations in a timely manner, providing corrections that ensure that the process follows the desired process trajectory to reach the desired outcome. PAT-enabled control systems may use process models based on first principles understanding or empirical models derived from experimental investigations or both. In addition to automated controls, a PAT-enabled control system may include components where there is manual intervention.
1.3 Principles described in this guide may be applied regardless of the complexity or scale of the PAT-enabled control system or whether applied to batch or continuous processing, or both.
1.4 The principles described in this guide are applicable to a PAT-enabled control system and also to its component subsystems. This guide does not cover the requirements for continuous quality verification of the overall process, which are covered in Guide E2537.
1.5 For information on science- and risk-based approaches in the pharmaceutical industry, reference should be made to ICH Q8(R2), ICH Q9, and ICH Q10. For guidance on PAT systems in the pharmaceutical industry, reference should be made to FDA Guidance for IndustryPAT and FDA Guidance for IndustryProcess Validation.
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 and health practices and determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
In the design and operation of reverse osmosis and nanofiltration installations, it is important to predict the CaSO4, SrSO4, and BaSO4 scaling properties of the concentrate stream. Because of the increase in total dissolved solids and the increase in concentration of the scaling salts, the scaling properties of the concentrate stream will be quite different from those of the feed solution. This practice permits the calculation of the scaling potential for the concentrate stream from the feed water analyses and the reverse osmosis or nanofiltration operating parameters.
Scaling by CaSO4, SrSO4, and BaSO4 will adversely affect the reverse osmosis or nanofiltration performance. This practice gives various procedures for the prevention of scaling.
SCOPE
1.1 This practice covers the calculation and adjustment of calcium, strontium, and barium sulfates for the concentrate stream of a reverse osmosis or nanofiltration system. The calculations are used to determine the need for scale control in the operation and design of reverse osmosis and nanofiltration installations. This practice is applicable for all types of reverse osmosis devices (tubular, spiral wound, and hollow fiber) and nanofiltration devices.
1.2 This practice is applicable to both brackish waters and seawaters.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

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SIGNIFICANCE AND USE
In the design and operation of reverse osmosis installations, it is important to predict the calcium carbonate scaling properties of the concentrate stream. Because of the increase in total dissolved solids in the concentrate stream and the differences in salt passages for calcium ion, bicarbonate ion, and free CO2, the calcium carbonate scaling properties of the concentrate stream will generally be quite different from those of the feed solution. This practice permits the calculation of the S & DSI for the concentrate stream from the feed water analyses and the reverse osmosis operating parameters.
A positive S & DSI indicates the tendency to form a calcium carbonate scale, which can be damaging to reverse osmosis performance. This practice gives procedures for the adjustment of the S & DSI.
SCOPE
1.1 This practice covers the calculation and adjustment of the Stiff and Davis Stability Index (S & DSI) for the concentrate stream of a reverse osmosis device. This index is used to determine the need for calcium carbonate scale control in the operation and design of reverse osmosis installations. This practice is applicable for concentrate streams containing more than 10 000 mg/L of total dissolved solids. For concentrate streams containing less than 10 000 mg/L of total dissolved solids, refer to Practice D3739.
1.2 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 and health practices and determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
These practices may be used to determine whether a RO or NF device is free of leaks if the mechanical integrity of the device is to be confirmed. They may also be used to detect leaks in RO or NF devices whose operating performance indicates a possible leak. These practices may be used for either new or used devices.
SCOPE
1.1 These practices cover detecting leaks in which there is a direct communication between the feed or concentrate, or both, and the permeate. Several types of leaks are possible with the various configurations of reverse-osmosis (RO) and nanofiltration (NF) devices.
1.2 Types of Leaks:  
1.2.1 With hollow-fiber devices, feed or concentrate leakage, or both, into the permeate stream by leaks through the tube sheet and past the tube sheet O-ring are possible. “Leaks” caused by broken fibers are not covered by these practices.
1.2.2 With spiral-wound devices, leaks may occur through damage of the membrane surface itself by punctures or scratches, by glue-line failure, and by O-ring leaks on product tube interconnectors.
1.2.3 With tubular devices, leaks due to membrane damage, tube end seal leaks, and leaks from broken tubes or product headers are possible.  
1.3 Three leak test practices are given as follows:
  Sections Practice A—Tube Sheet and O-Ring Leak Test for Hollow
Fiber Devices 8 to 9 Practice B—Vacuum Test for Spiral Wound Devices10 to 12 Practice C—Dye Test for Spiral Wound and Tubular Devices13 to 18
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

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SIGNIFICANCE AND USE
The results obtained by this test method should serve as a guide in, but not as the sole basis for, selection of a lining material for particular application. Simple chemical-resistance evaluations of the lining materials may be performed more conveniently by other pertinent methods as a prescreening test for this procedure in accordance with Test Methods C 267 and D 471.
SCOPE
1.1 This test method covers a procedure for evaluating the chemical resistance of a polymer-based protective lining in immersion service. The method closely approximates the service conditions, including the temperature differential between the external and internal surfaces of the equipment, which may accelerate permeation of the lining by a corrosive media.
1.2 This test may be used to simulate actual field use conditions insofar as a qualitative evaluation of the lining system after a predetermined period of exposure.
1.3 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 considered standard.
1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

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