Bs En 15512 Pdf

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Darci Carlton

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Aug 5, 2024, 2:48:18 AM8/5/24
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AR15512 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This represents the significant need for an effective chronic treatment that can provide rapid natural tear production.1

In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported.


AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024.


About Dry Eye

Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the United States and an estimated 719 million more adults globally.1 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.2 Many existing prescription options for dry eye disease are generally regarded by many eye care professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.3


Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.


Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.


I have 1 user who reported today that they could no longer log in to their computer through LMI. They could still hit the control-alt-delete button to log in, but after doing that, they were unable to type anything through LMI. But everything worked perfectly fine for me to remote control their computer using my user account.


The way that the permission descriptions are written (link), it's actually not clear to me whether checking the checkbox of these new permissions enables or disables the ability to use these functions. For example the description for the new Keystrokes permission says "Disable all keystrokes from the client sent to the remote host during remote control". So if I check that checkbox, am I enabling or disabling the user to send keystrokes? When I examine a user that has "full control", these checkboxes are all checked, so for example that makes it seem like checking the checkbox allows the user to send keystrokes.


I only really just discovered this a bit ago, so I haven't fully tested yet. But, if these new permissions could effectively default to locking out all non-admin users from using LMI, that might constitute a semi-emergency that should be raised sooner than later. That said, apologies if this winds up being a false alarm.


If I uncheck the "Keystrokes" permission, I am no longer able to type through LMI. (Although I can still access the on-screen keyboard.) Once I re-check the permission, I can type again.


So...yeah. Unless my experience is somehow unique, you probably won't want 15512 until maybe these new permissions can default to being enabled for users who already have remote control permissions.


Good to know that the rollout has been paused! This new option is easily overlooked and also caused me a bit of frustration today until I'd noticed the version difference. If I've already granted a user remote desktop access, maybe the default keystroke option should be enabled in this instance?


I had a somewhat of disaster of a morning because of this update. Many of my users were able to connect, but not type after connecting. After a fairly long tech support call the solution they offered was to give the users "full control" permissions which fixes the problem.


Same issue here today and yesterday. Two LogMeIn Central hosts had updated themselves, and the default permissions for BUILTIN\Users do not allow Keystrokes which means users cannot type when they connect via LogMeIn, nor Blank Screen because that's also been added.


Per Glenn's post above, hosts should have stopped getting updated to 15512 as of June 21st. But I checked the release notes again today, and I see that new version 15530 was released June 27th (today), and it is indicated for 15530 that this issue should be fixed. None of my hosts have been automatically updated to 15530 yet, so I don't know, but I'm just looking to plan accordingly as needed.


For your purposes, please don't take my word for it because I'm just a random guy, but maybe a workable solution could be to force the affected hosts to update to 15530? We can trigger hosts to update from the Central admin control web interface.


A solution I had in the works was to export the registry key from the BUILTIN\Users group that had the permissions for Blank Screen and Keystrokes granted, then to deploy that via group policy to affected machines.


The registry key is in Computer\HKEY_LOCAL_MACHINE\SOFTWARE\LogMeIn\V5\Permissions and it's called AccessMask. One subkey is created for each user being granted permission, so as long as I was targeting a group all users were in, it should apply fine.


1.1 ISO 15512:2016 specifies methods for the determination of the water content of plastics in the form of powder, granules, and finished articles. These methods do not test for water absorption (kinetics and equilibrium) of plastics as measured by ISO 62.


Method A is suitable for the determination of water content as low as 0,1 % with an accuracy of 0,1 %. Method B and Method C are suitable for the determination of water content as low as 0,01 % with an accuracy of 0,01 %.


? Method A is an extraction method using anhydrous methanol followed by a Karl Fischer titration of the extracted water. It can be used for all plastics and is applicable to granules smaller than 4 mm 4 mm 3 mm. The method can also be used for, e.g. prepolymer materials in the form of a powder that are insoluble in methanol.


? Method B1 is a vaporization method using a tube oven. The water contained in the test portion is vaporized and carried to the titration cell by a dry air or nitrogen carrier gas, followed by a Karl Fischer titration of the collected water. It can be used for all plastics and is applicable to granules smaller than 4 mm 4 mm 3 mm.


? Method B2 is a vaporization method using a heated sample vial. The water contained in the test portion is vaporized and carried to the titration cell by a dry air or nitrogen carrier gas, followed by a Karl Fischer titration of the collected water. It can be used for all plastics and is applicable to granules smaller than 4 mm 4 mm 3 mm.


? Method C is a manometric method. The water content is determined from the increase in pressure, which results when the water is evaporated under a vacuum. This method is not applicable to plastic samples containing volatile compounds, other than water, in amounts contributing significantly to the vapour pressure at room temperature. Checks for the presence of large amounts of volatile compounds are to be carried out periodically, for example by gas chromatography. Such checks are particularly required for new types or grades of material.


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Methods: In a Phase 2b study, patients with DED were randomized 1:1:1 to 0.0014% AR-15512, 0.003% AR-15512, or vehicle twice daily for 12 weeks. Eligibility criteria included DED signs and symptoms of prespecified severity levels. Outcomes assessed were DED signs (Schirmer score anesthetic, ocular surface staining, hyperemia), symptoms (Ocular Discomfort [ODS-VAS], Symptoms Assessment iN Dry Eye [SANDE], Eye Dryness-VAS, Ocular Pain-VAS), QoL-VAS, and adverse events. Co-primary endpoints were changes from baseline in ODS-VAS and anesthetized Schirmer score at Day 28.


For this reason, industrial racking systems must follow specific structural design criteria. The EN 15512 European standard defines the requirements to be considered in calculating the structure. In this post we will look at some of the key aspects and questions of this recently updated regulation.


EN 15512 is not the only standard that must be considered with respect to the design and manufacture of industrial racking systems. In Europe, there are 4 main standards that are considered and used jointly:

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