References for Annex

Draft Standard IEC 61508, Functional Safety of Electrical/ Electronic/ Programmable Electronic Safety-Related Systems , (Contact BSI/IEC for availability) 

J A Barton R L Rogers, (ed.), Chemical Reaction Hazards , 2nd Edition, IChemE, 1997, ISBN 0 85295 3410 

HAZOP and HAZAN - Identifying and Assessing Process Hazards , 3rd edition, IChemE, Rugby, 1992 

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As mentioned previously, the authorization process starts with the identification of a substance as substance of very high concern (SVHC). For this purpose, the ECHA on behalf of the European Commission or a member state competent authority prepares a dossier. It generally includes a proposal for the identification of a substance as SVHC, a justification for this proposal and information on the substance s use, exposure, and risks as well as on alternatives. The extent of the justification may differ considerably between substances and may range from a sophisticated assessment of the harmful effects caused by the substance to a simple reference to Annex VI Part 3 of the CLP Regulation if a harmonized classification... 

Unacceptable starting materials used in research must be replaced by those which meet the regulatory quality and safety criteria. Reference to standard volumes of pharmaceutical ingredients and excipients should be made to decide whether a certain ingredient can be used. Standards are described in the pharmacopoeias of relevant countries, the "Handbook of Pharmaceutical Excipients" or its Swiss anchestor the "Katalog pharmazeutischer Hilfsstoffe". Fiedler s "Lexikon der Hilfsstoffe" (Lexicon of Excipients) provides many useful informations about the safety and about applications for excipients. (For references see Annex B to the registration requirements chapter.)... 

Annexes 5.1 and 12.1 give examples of reporting forms elaborated in BCR (Bureau Communautaire de Reference) for the certification of inorganic and organic parameters in environmental matrices. They may be used as a basis to prepare reporting forms for all type of interlaboratory studies. The elaborate questions listed in the forms are intended to remind the participant of important parameters, which affect the quality of the final result. They can also be used in the technical discussion with the other participants when differences in results are noticed. Finally, they form the basic information for the preparation of certification reports in case certification is considered (see chapter 5). 

These are described briefly in the following sections, to give an appreciation of the variety of designs and some of their characteristics. Space constraints mean that it is only possible to include reference to a limited number of designs and the omission of a particular design should not be taken as a comment on its merits. Quoted kiln characteristics are based partly on manufacturers data and partly on achieved performances. References for further reading are included to assist the reader requiring more detailed information, but reference should also be made to recent editions of the trade journals (Annex 2) and to the manufacturers literature. 

Users and designers should refer to Annex A of this standard for guidance in techniques available to ensure SIS design satisfies performance relating to random hardware failures. 

Whereas Art. 6 relates to certain substances, Art. 7 relates to the Use of certain source materials, which is even more important in relation to herbs, spices, extracts, and essential oUs. This article refers to Annex IV of the regulation, which is a new Annex that was not in the former avoring directive 88/388/EC entitled List of source materials to which restrictions apply for their use in the production of avourings and food ingredients with avouring properties. Annex IV consists of two parts ... 

Alarms for which an operator or facility worker is required to evacuate an area (e.g., fire and gas alarms) and are not intended to direct the operator to take action on the process are generally not considered safety instrumented functions. These alarms should not be allocated to the BPCS but may be allocated to the SIS or to another independent protection layer. Refer to Annex F, Figure F.1, for an overview of protection layers. These alarms are generally classified as safety-related and are designed and managed in a manner that supports the allocated risk reduction. 

A risk reduction equal to or greater than 10 can be claimed where an operator, as a result of an alarm, takes action to place the process in a safe state. To take credit for a risk reduction equal to or greater than 10, a risk analysis should be performed to verify its feasibility. It is especially important to determine whether there is sufficient human response time. Refer to Annex B.5 for more discussion on human response time. 

Note 5 - Refer to Annex K for fault tolerance guidance. 

While the requirement in Clause 11.2.8 allows you to specify an alternate way to provide this protection in your Safety Requirements Specification, just stating that you will not provide it is not an acceptable alternative. Refer to Annex B of this technical report for a discussion of operator-initiated safety functions and to Annex F for a discussion of the relationship between the SIS and BPCS. Any procedures required to continue safe operation should be documented, including the training of operation and maintenance personnel. 

In this case, the process engineer determined that upon detection of a dangerous fault, the SIF should be initiated. A diagnostic alarm is displayed on the BPCS HMI to alarm when the SIF level signal falls below -5%, which indicates a failure of the SIF level transmitter. When the operator receives the alarm, the operator manually activates the SIF per the operating procedures to bring the system to a safe state. The hazard and risk analysis indicated that there was sufficient process safety time for the operator to respond effectively (refer to Annex B for more information on operator alarm with response). Alternatively, the SIF could be configured such that on detection of transmitter failure, the SIF is automatically initiated. 

Refer to Annex 5 for a more detailed discussion about the treatment of the BPCS in the LOPA for the overflow of an atmospheric storage tank. 

While ISO 16505 includes a qualitative requirement, UN Regulation No. 46 defines a limit of 20 % relative to the recto-linear or pinhole projection for Class I, II and III CMS. Regarding the test method, UN Regulation No. 46 refers to Annex G.3. of ISO 16505. 

Over the past decades, mirror systems have been adjusted due to changed and expanded regulations [83, Annex 6], [84, par. 1.5.2.4] and ergonomic developments by the system suppliers and car manufacturers to meet the requirements of changing transportation task (see Sect. 1.1.1). The current mirror systems thus are the reference for the development of new electronic vision systems, such as the CMS (see [90] Scope). 

For use with gaseous phase samples, refer to Annex Al. 

Note 7—Refer to Annex A6 of Test Method D 2892 for ftirther details concerning the calibration of pressure sensors and McLeod gages. 

DEKALB Genetics Corporation. 1997. USEPA CrylAc-corn registration submission, MRID (Master Record Identification) 439995 (The MRID numbers provided represent a package of documents submitted to support a registration submission. See Tables and References in Annex for individual reports). ... 

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