Acceptable level of safety

The EU will accept applications without supporting pre-clinical and clinical data, if it can be demonstrated that the active substances have been in well-established medical use in the Community for at least 10 years, with recognised efficacy and an acceptable level of safety. This route would be appropriate for many common over-the-counter (OTC) products. Safety and efficacy is supported by providing copies of published scientific literature as part of the submission that is, the submission relies on safety and efficacy data available in the public domain, as opposed to confidential data from authorised applications that is the cornerstone of generic applications. 

False. Fireworks do cause a large number of fires and injury accidents every year. However, if the user follows the Firework Code it is possible to enjoy them with an acceptable level of safety. A non-safety argument for banning them could be made on the grounds that their use often frightens animals and annoys nearby residents. 

To achieve an economical electrical installation which will provide an acceptable level of safety at the lowest possible cost. 

Detailed references in published scientific literature are sufficient to demonstrate that the constituents of the product have a well-established medicinal use, with recognised efficacy and an acceptable level of safety or... 

Schedule I—The drug has a high potential for abuse, is not currently accepted for medical use in treatment in the United States, and lacks accepted levels of safety for use under medical supervision. 

Generic studies of geologic disposal conducted by the Swedish KBS, the Commission of European Communities (CEC), and others have concluded that geologic disposal systems can achieve an acceptable level of safety to protect future generations from the radiological hazards associated with these wastes. 

Detailed references to published scientific literature are provided which demonstrate the components of the pharmaceutical speciality in an established medical use and provide a recognised efficacy with an acceptable level of safety. 

To qualify the preceding sbghfly — connechng the metal enclosure of the equipment to earth can sometimes be considered as an acceptable level of safety protechon — there are exceptions to this, as we will soon learn. However, assuming for now that earthing is acceptable, we know that to protect the user in case the earth connection fails (maybe due to something as simple as a loose contact), we need to provide one more level of protection. So this could simply be the 4 mm of separahon. 

Nonprescriptive standards are, of necessity, performance-based because there is no external specific standard against which they can be assessed. Also, it is never possible to be in compliance. Ultimately, the only measure of success is success. Consequently, from a theoretical point of view, it is impossible to achieve compliance. The only truly acceptable level of safety is perfection. Yet, no matter how well run a facility may be a zero accident rate is a theoretically unattainable goal. Risk can never be zero. Indeed, if a facility operates for long enough, it is certain—statistically speaking— that there will be an accident. Therefore, management has to determine a level for acceptable safety. And because risk can never be zero, there are always ways of improving safety and operability. 

That recommendation paved the way to a transition from prescriptive requirements to more goal-based requirements expressed in functional terms, which gave the operating party opportunities to choose which detailed solutions could be used to operate safely, and in accordance with the level of standard set in the regulations. That the activity is to be conducted in an acceptable manner expresses a legal standard which provides no direct specification of the level of safety required. The content of the standard will depend on current social perceptions, practice in the petroleum industry, and so forth. The requirement to maintain an acceptable level of safety can thereby change in line with developments (Hagen et ak, op cit, p. 449.)... 

The deterministic approach is mainly used to prove the acceptable level of safety. This approach is represented by the part of the safety analysis report (SAR) dealing with LPS during the plant operation. The probabilistic method is used to demonstrate the overall safety reached during LPS operation and to identify possible plant weaknesses during these operational modes. 

Since absolute safety is an unattainable goal, the aim is to use medicines with an acceptable level of safety. Various factors need to be considered in judging whether safety is or is not acceptable ... 

A hazard assessment using this level of process definition rarely provides an acceptable level of safety. 

For most processes a hazard assessment based on a process definition that includes non-specific faults (Section 2.4.3, page 18) is the minimum standard that leads to an acceptable level of safety. 

The directives shall set out the range of possible choices which can be considered which may be considered by the Council to give the authorities the acceptable level of safety they seek for a given product or product sector ... 

Note Up to this level, the goal-based safety criteria (either via regulations such as CS/FAR25.1309, or flowed down from the System Level 5 accident sequence models, refer Chapter 11) is the most appropriate method to evaluate an acceptable level of safety. 

Provides a systematised framework (driven by robust requirements V V) for reasoning that the equipment will execute in the operational context with an acceptable level of safety. The systematised framework provides confidence to certification authorities and developers that the most important properties have been addressed with suitable evidence. 

An AD is issued by the Regulator to end users. It mandates actions to be performed on an aircraft to restore an acceptable level of safety, when evidence shows that... 

Airworthiness Directive A document issued or adopted by the Agency which mandates actions to be performed on an aircraft to restore an acceptable level of safety, when evidence shows that the safety level of this aircraft may otherwise be compromised. [Regulation (EC) 748/2012 21 A.3B Airworthiness directives and Regulation (EC) 1702/2003 21A.3B Airworthiness directives]. 

The risk criterion is a term, which may distinguish between what is considered as an acceptable level of safety and what it is not. 

ACCEPTABLE LEVEL OF SAFETY RISK FOR COMBAT PISTOL AND AMMUNITION... 

Requirements for weapons and ammunition design safety are sufficiently elaborated and described in literature (Allsop, D. et al. 1997, Balia Fiser 2008, Beer et al. 2004, Fiser Balia 2004) and in standards today. On the other hand, the requirements for risks of safety failure of small arms and their ammunition have not been published and elaborated yet. No absolute guarantee of safety can ever be given. Therefore it is necessary to determine an acceptable level of safety risk in requirements for both new weapon and new ammunition. 

Challenges related to modification of existing hoist equipment is well is the adoption of new technologies are presented with suggested approaches to achieving acceptable levels of safety. 

If the hazard control measures (engineering or PPE) are not adequate to prevent exposure and provide an acceptable level of safety, laboratory management should not permit the experiment or procedure in question, and should explore whether a safe substitute for COCs can be identified. 

While national consensus and voluntary standards may not be enforceable, unless a regulatory agency adopts them, such as OSHA, they still serve as a recognized acceptable level of performance. In some cases, the national consensus standards may be viewed as the minimum acceptable level of safety performance. 

Safety measures to be taken on board ship must comply with international conventions adopted and put into force in the French merchant navy. They concern the 1974 SOLAS Convention for the Safety of Human Life at Sea (the establishment of an acceptable level of safety onboard ship), the MARPOL 73/78 Convention for the Prevention of Sea Pollution by Ships, and the 1972 Container Safety Convention (CSC). 

Produce safety case to show that acceptable level of safety is achieved. 

This leads us into the primary purpose of a Safety Case broadly, it is the documented means by which those who are accountable for on-going service provision, or for managing changes to that service and/or underlying system, assure themselves, that those services or changes deliver an acceptable level of safety. 

Argl focuses on the output of the Concept stage of the lifecycle - ie a set of Safety Requirements for the Change that ultimately satisfy the three safety criteria which define an acceptable level of safety. 

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